Conference • Tuesday, October 2, 2007 - IBC Life Sciences

THE Meeting Place for the BioprocessingIndustry to Learn New Approaches toBiopharmaceutical ManufacturingConference: October 1-4, 2007Exhibition: October 1-3, 2007Hynes Convention Center, Boston, MARecent changes in the biopharmaceutical manufacturing industry includeregulatory evolution, dramatic improvements in upstream yields and neweconomic pressures on biotech drugs. The design space concept opens thedoor to greater regulatory flexibility and reduced validation requirements.Upstream advances impact downstream processes. Regulatory changes affecteveryone. That’s why it’s more important than ever to be on top of all thesedevelopments to make the most of these changes at your company.BioProcess International Conference and Exhibition is the one place whereyou can get the information you need, benchmark your efforts againstpeers, get frank future forecasts in small group settings as well as visionarykeynotes – all in a program developed by the industry, for the industry.BPI is the most well-attended, highly-respected meeting focused just onbiopharmaceutial industry manufacturing challenges.This year IBC and our distinguished advisory committees have developeda program with a theme of evolving regulatory initiatives and processcapabilities so you can streamline process development and capacityplanning. Presenters will show you how they have utilized new typesof facilities, technologies and licensure avenues to quickly achievemanufacturing friendly processes in compliance with internationalregulatory guidelines.Hear experiences from theindustry leaders as well asmany small- to mid-sizedcompanies to find solutionsthat will work in yourspecific situation.EYE ON THEFUTUREFeatured Presentations:Future of Cell Line and Process DevelopmentBarry C. Buckland, Ph.D., Research Vice President BioProcess R&D,Merck Research LaboratoriesLessons Learned and Not – Future Directions in ChromatographyJohn Curling, Chief Executive Officer, John Curling Consulting AB, SwedenPoint/Counterpoint AudienceInteractive Panel Discussion:The Future of Downstream Processing:How Best to Handle Higher BioreactorOutputs and Greater Product Demands4 Conference Tracks for CustomizedInformation Gathering:• Production & Economics of Biopharmaceuticals• Scaling Up from Bench through Commercialization• Cell Culture & Upstream Processing• Recovery & PurificationNew Sessions for 2007:• Scale Down Models, Process Characterization and Validation• Early Stage Process Development – Getting to the Clinic Faster• Next Generation / Disruptive Purification Technologies• Overcoming the Challenges of the Ton Scale ProcessNew! In-Depth Pre-Conference Workshops:• Workshop A: Analytical Methods for Process Development, ProductCharacterization and Formulation Screening• Workshop B: Transient Expression SystemsAudience Interactive Panel Debates on:• Analytical Methods• Impact of Regulatory and Industry Trends on Process Development andManufacturing strategies• Scale Down Models, Process Characterization and ValidationSpecial Attractions:• Site Tours at Applied Biosystems, Biogen Idec and GE Healthcare• Exhibit Hall Packed with 120 Suppliers and 1300 Attendees• Collaborative Learning Experiences in Small Working Groups• Exhibit Hall Networking Receptions - The Place to Mix & Mingle!New! Co-Located Formulation Strategies for ProteinTherapeutics Conference:• Practical case studies and survey presentations to help accelerate andimprove formulation development• Joint industry/supplier panel on prefilled syringes• Interactive Scientific Exchange sessions in which delegates work through aproblem-solving exercise to resolve aggregation problems in formulatinghigh concentration antibody products• Purchase the Dual Conference Pass and gain access to conference sessionsand materialsNew! Professional Development Courses:• Technology Transfer of Biopharmaceuticals to Ensure a SuccessfulTransfer and Implementation of Processes• Introduction to Biopharmaceutical Manufacturing to Gain OverallPerspective on Processes and Operations, Understanding ofTechnologies, Testing Methods and Process Validation• Design of Experiments and How to Use Designed Experimentsto Perform Efficient Drug Development in BiopharmaceuticalManufacturing Processes“Off-the-Record” Break-Out Discussions:• Strategies for Small Companies Managing Late Stage Development• Modeling Up and Scaling Down: Use of Model Systems in ValidationAssurance*• Quality by Design: Aspiration and Application*• The Impact of Evolving Process Capabilities and Adaptation on Facilities• Making the Connection: How to Hire, Train, and Retain Talent• Building the Biomanufacturing Education and Training Infrastructure* Attendance is limitedNo other event provides you with a better return on your investment with new insights, new collaborators, new approaches – and new ways to help your candidate get to marketfaster, with more competitive COG, assured potency and patient safety.To maximize your return even further, see the vast majority of vendors in this space under one roof with one of the largest exhibitions of suppliers to biopharmaceutical manufacturersin the world.Reserve your place today at the industry event of the year and take advantage of early bird and team discounts.

Begin with strategic planning and continue through state-of-the-art technologies for a comprehensive conference programProduction & Economics of1 BiopharmaceuticalsLearn the latest strategies for capacity planning used by small and largecompanies, including outsourcing, building, offshoring, and optimizingpresent facilities, for a variety of molecule types. Hear about implementationof operational excellence, six sigma and lean manufacturing to mitigatecontamination risk at Genentech’s Vacaville plant, to improve operationaleffectiveness at Human Genome Sciences and to enable a high-throughputproject portfolio at Wyeth BioPharma. Understand how to evaluatepotential cost savings by using single-use or disposable technologies,and how biosimilars and follow-on biologics will affect the future ofbiopharmaceutical manufacturing.2Scaling Up from Bench throughCommercializationHear process development strategies from Amgen and Genentech includinghow these industry leaders plan production networks and design facilities, fromclinical through commercial manufacturing. Biogen Idec presents case study onchallenges of process development for a PEGylated protein and how they wereovercome in R&D, Manufacturing/Facilities and Quality departments. Learnabout Pfizer’s and Lilly’s recent experience with design space. Gain updateson PAT from a European regulator, and learn about industry experience withcomparability, post-licensure changes and ICH Q8, 9, and 10 from Genentech.Attend an in-depth session on scale-down models including case studies of thosethat were—and were not—predictive of large scale production and understandhow to use them in process validation and characterization with case studiesfrom VIRxSYS, Protherics, Biogen Idec and PDL BioPharma.Production and Economics TrackGeorge Avgerinos, Ph.D., Director, Technical Operations,Global Pharmaceutical Operations, Abbott Bioresearch CenterWolfgang Berthold, Ph.D., Chief Technical Officer, Biogen IdecFrank Jackson, Vice President, Genentech Vacaville Product OperationsHoward L. Levine, Ph.D., President, BioProcess TechnologyConsultants, Inc.Duncan Low, Ph.D., Scientific Executive Director, Process Development,Amgen, Inc.Abhinav Shukla, Ph.D., Associate Director Bioprocess Engineering,Bristol-Myers SquibbScaling Up from Bench throughCommercialization TrackJeffrey C. Baker, Ph.D., Senior Research Advisor, Six Sigma Black Belt,Manufacturing Sciences and Technology, Eli Lilly and Co.Alex Fotopoulos, Director of Engineering, Biogen IdecRichard Francis, Director of Process Development and Technical Support,Protherics, United KingdomRoger A. Hart, Ph.D., Scientific Director, Process Development, AmgenManinder Hora, Ph.D., Vice President, Process Development, PDLBioPharma, Inc.Dr. Günter Jagschies, Director R&D, Customer Applications,GE Healthcare Bio-Sciences, SwedenTom Ransohoff, Senior Consultant, BioProcess Technology Consultants, Inc.Frank J. Riske, Ph.D., Director, Purification Development, GenzymeCorporation3CellSpecial Thanks to the Scientific Advisory CommitteesCulture & Upstream ProcessingLearn how companies are accelerating development of high producing celllines while improving product quality through the successful combinationof proven approaches with a wide range of novel technologies. Case studiesfrom Avecia, Boehringer Ingelheim, Centocor, Genentech, Lonza Biologics,US Army and Wyeth will cover the latest breakthroughs during early stagedevelopment that will help dramatically decrease the time to clinic. Amgen willlead a discussion on approaches to reduce lot-to-lot hydrolysate variability thatwill include perspectives from the main media suppliers. Gain valuable insightsfrom industry leaders who are leveraging data to improve process consistency,reliability and productivity to help you achieve total process optimization.4Recovery& PurificationDiscover how companies are optimizing processes and avoiding costlybottlenecks with state-of-the-art technologies to increase robustness to ensureproduct quality. Hear the latest developments with chromatographic and nonchromatographicmethods, ultrafiltration, automation, analytical technologies,data analysis and process control to improve process efficiency, economy andquality. Thought leaders will discuss evolving regulatory guidelines and theirimpact on process validation, characterization and viral clearance. Exclusivecase studies from industry leaders will demonstrate companies that haveachieved significant improvements with new stationary phases and monoliths inchromatography, platform technologies, disposables, automated analytical assays,to increase the yield and speed of recovery and purification.Cell Culture & Upstream Processing TrackMike Berry, Ph.D., Director of Cell Culture & Fermentation, Process Sciences,Nuvelo Inc.Timothy S. Charlebois, Ph.D., Director, Cell & Molecular Sciences, Wyeth BioPharmaLaurel Donahue-Hjelle, Ph.D., Director of Cell Line Development, InvitrogenCorporationKevin J. Kayser, Ph.D., R & D Manager, Cell Line Engineering, SAFC BiosciencesDennis M. Kraichely, Ph.D., Principal Research Scientist, Pharmaceutical Development,Centocor R&D, Inc.Jim Michaels, Ph.D., Director of Cell Culture and Fermentation, BioMarinPharmaceuticals, Inc.John Mott, Ph.D., Director, Bioprocess R&D, Cell Line Development, Pfizer GlobalBiologicsCharles Sardonini, Ph.D., Associate Director, Process Engineering/Development,Genzyme CorporationThomas Seewoester, Ph.D., Director, Process Development, AmgenJanani Swamy, Ph.D., Director, Cell Culture Operations and Technical Services,Genzyme CorporationRon Taticek, Ph.D., Associate Director, Fermentation MSAT, SSF BiochemicalManufacturing, Genentech, Inc.Recovery and Purification TrackJoanne Beck, Ph.D., Director of Biologics Manufacturing, Abbott Bioresearch CenterEdward Cole, Ph.D., Senior Vice President, Protein Development, GenzymeCorporationChris Dowd, Ph.D., Senior Engineer, Late Stage Purification, Genentech, Inc.Uwe Gottschalk, Ph.D., Vice President, Purification Technology, Sartorius, GermanyBrian R. Hubbard, Ph.D., Scientific Executive Director, Process and Analytical Sciences,AmgenDavid W. Kahn, Ph.D., Director, Late-Stage Purification Development, Human GenomeSciences, Inc.Peter W. Wojciechowski, Director, Purification Technology, Global Biologics SupplyChain, Centocor

Pre-Conference Workshops • Sunday, September 30, 2007Note: The Pre-Conference Workshops take place at the Sheraton Boston Hotel (attached to the Hynes Convention Center). All other sessions will take place at theHynes Convention Center. Sheraton Boston Hotel, 39 Dalton St., Boston, MA 02199 • 800-664-6835Workshop A:Analytical Methods Utilized throughout ProcessDevelopment, Product Characterization andFormulation Screening:Matches Made in Heaven or Shotgun Weddings?In many organizations – even large ones - process development, analyticalmethod development, and formulation groups do not have meaningful linkagesamong them to assure that there is adequate alignment of the analyticaltest methods from which all data-driven decisions are made. For example,the process design space is often defined by increased amounts of API withdecreased amounts of process-related impurities (e.g. HCP).Product-related impurities (e.g. degradants) can easily arise duringmanufacturing operations. It is understood that methods used for drugsubstance testing should be verified for their stability-indicating capabilities.But what about methods used for process development? Or methods used forformulation development? Without adequate analytical method capabilities andappropriate alignment of test method procedures, process capabilities cannot beaccurately assessed and formulation optimization could be a wasted effort.This workshop will discuss both regulatory and practical issues necessary forassuring that the combined set of measuring tools used for making key process,product and formulation decisions end up as marriages made in heaven, notshotgun weddings. The workshop facilitators will emphasize highly interactivediscussions among attendees on their experiences and strategies with bothoutcomes.1:30 Co-Chairperson's Opening RemarksNadine M. Ritter, Ph.D., Senior Consultant,Biologics Consulting Group, Inc.Keith H. Wells, Ph.D., Senior Consultant, Biologics Consulting Group, Inc.1:40 Analytical Methods for Biotechnology Products: Heroicor Horrific?Nadine M. Ritter, Ph.D., Senior Consultant,Biologics Consulting Group, Inc.2:10 Regulatory Overview of Process DevelopmentKeith H. Wells, Ph.D., Senior Consultant, Biologics Consulting Group, Inc.2:40 Networking Refreshment Break3:00 Voraxaze: Meeting the Regulatory Challenge CaseStudyRichard Francis, Director of Process Development andTechnical Support, Protherics, United Kingdom3:30 Vaccine for CDAD – Challenges in AnalyticalMethod Development for Process,Formulation, and ProductHersh Mehta, Ph.D., Senior Director, Development, AcambisCaseStudy4:00 Audience Interactive Panel Discussion with all Speakers5:00 End of WorkshopWorkshop B:Transient Expression Systems1:00 Chairperson’s Opening RemarksYves Durocher, Ph.D., Project Leader, Mammalian Cell Technology,Biotechnology Research Institute, National Research Council Canada, Canada1:10 Introduction to Transient Expression SystemsMammalian cells are the host of choice to produce complex recombinantproteins (r-proteins) because of their capability for proper protein folding,posttranslational modifications and assembly. In order to accelerate thediscovery to clinical application phase, significant quantities of r-proteinsmust be available as quickly as possible. Large-scale transfection ofmammalian cells has become a key technology that can reliably delivermilligram to gram quantities of a r-protein in less than one month.Yves Durocher, Ph.D., Project Leader, Mammalian Cell Technology,Biotechnology Research Institute, National Research Council Canada, Canada1:50 Development Towards High Yield in Large ScaleTransient Protein Production in CHOTransient production in CHO has been problematic. Yields similar to HEK293 cells have been hard to achieve since some characteristics that makeCHO an excellent host for stable production hinder transient production. Wewill present data to demonstrate the utility of a new transfection system wedeveloped to overcome some of these hindrances to reach over 0.5g of MAbfrom only 10L of culture.Henry C. Chiou, Ph.D., Technology Area Manager, Molecular BiologyEssentials R&D, Invitrogen Corporation2:30 Protein Production Via Large Scale TransientTransfection of Mammalian CellsCaseStudyAbstract unavailable at press time. Please visit IBCLifeScience.com/BPI/USfor updates.Gerald F. Casperson, Ph.D., Associate Fellow, Biotherapeutics, Pfizer, Inc.3:10 Networking Refreshment Break3:40 Addressing IgG Expression Issues and ImprovingProductivity during Transient ExpressionCaseStudyAn efficient transient expression system facilitates rapid expression of IgGs forproof of principle studies during drug development at Cambridge AntibodyTechnology (CAT). This case study will highlight the efficient transientexpression system in use at CAT and strategies in place to address poor IgGexpression issues. Data will be presented from the analysis of some ‘difficult toexpress IgGs’.Lekan Daramola, Ph.D., Head of Antibody Format Technologies, CellSciences, Cambridge Antibody Technology, United Kingdom4:20 Novel Approaches for the Improvement ofTransient Expression using CHO CellsCaseStudyProtein production by transient gene expression in CHO cells, especially inprotein-free systems, has suffered from low productivities. This presentationdescribes Lonza’s experience with different chemical and physical approachesfor increasing recombinant antibody production in protein-free CHO systems.Concentrations up to 40 mg/L were achieved in shake-flask culturesAlison J. Mastrangelo, Ph.D., Science Leader, Cell Culture ProcessDevelopment,Lonza Biologics, United Kingdom5:00 End of Workshop5 To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com

Main Conference • Monday, October 1, 2007 (continued)4:00 Biomanufacturing Capacity –Chapter and VerseThe three historical chapters of biomanufacturing have beenidentified as: Just Make the Product, Break the Bottleneck andCover Your Assets. Review these past chapters, and define keyelements of the future, fourth chapter in the industry.Understand the dramatic improvements in manufacturing process outputs andthe emergence of standardized processes and facilities, and potential for morestrategic approaches. When coupled with extensive capacity sharing betweencompanies, the future growth of the industry may no longer be constrained byproduction capacity nor burdened by production costs.Michael E. Kamarck, Ph.D., Senior Vice President, Wyeth Biotech TechnicalOperations and Product Supply, Wyeth PharmaceuticalsKeynote Presentations4:45 Genentech's Manufacturing Strategyand Vision of Future NeedsThe presentation will focus on Genentech's manufacturingstrategy as it transitions from maximizing output tooptimizing its production network. The talk will include thestrategy for clinical as well as commercial productiondelivering current and anticipating future production needs as Genentechadapts and expands its network in South San Francisco, Oceanside, Vacavilleand Singapore.Markus Gemuend, Senior Vice President, Biochemical Manufacturing,Genentech, Inc.CO-LOCATED5:30 Exhibit Hall Opens with Cocktail Reception Sponsored byNetwork with your peers, learn about new products and services from over 100 exhibiting companies,and see cutting-edge data in a large group of posters.IBC’s 7th AnnualFormulation Strategies for Protein TherapeuticsA Case Study and Best Practices Forum Dedicated to Improving the Quality and Speed of Formulation DevelopmentMonday Highlights Include:• Pre-Conference Workshop: The Progression of Drug Product Formulation: Gates Between Discovery,Development, Approval and Post-Approval• Keynote Presentation: Mechanisms of Protein Degradation Processes and Implications for Shelf Life Predictionsand Rational Formulation; Bernhardt L. Trout, Ph.D., Associate Professor, Department of Chemical Engineering,Massachusetts Institute of Technology• Session on Advances in Stability Analysis, with topics including Predicting Chemical Instability from Protein Sequence, The Role of Bioassayin Formulation Stability Programs and Analysis of Regulatory Stability Guidances• Case Study: Post-Approval Formulation Changes for International MarketsFounding PublicationBioProcess International is concerned with theapplication of biotechnology to industry, particularly tothe development and manufacture of biopharmaceuticalapplications including: proteins, peptides, hormones,vaccines, oligonucleotides, gene therapies, cell and tissue therapies and biodiagnostics.BioProcess International provides biotechnology vendors with the most effective, most cost efficentprint and online access to 30,029 biotherapeutic decision makers working throughout the world.BioProcess International's advertisers are the leading suppliers of equipment, technologies, contractservices and materials necessary for biotherapeutics companies to complete each phase of thebiodevelopment process in the most timely, successful and economic matter.To learn more about BioProcess International visit www.bioprocessintl.comRegister for the DualConference Pass andGain Access to theseConference Sessions andMaterialsMedia PartnersMain Conference • Tuesday, October 2, 20077:15 Technology WorkshopReaching Extremely High Protein & Antibody Expression 30-80pg/Cell/Day in Three Weeks inFast-Growing CHO CellsAmProtein Corporation has just discovered a DNA structure-based common mechanism for possibly all eukaryotic gene expression. Based on this discovery, AmProtein has rapidly generatedmore than 10 cell lines, which produced more than 10 different proteins and antibodies at levels of 30-80 pg/cell/day. All these were achieved in three weeks in fast growing CHO cells afterstable gene trasnfections. These results strongly suggested that this discovery has revolutionized protein production industry and make mammalian protein production rapid, affordable anddominant over other transgenic production methods. Currently, AmProtein is working on the more detailed mechanism and is applying this discovery to plant and insect gene expression.Matthew Hui, Ph.D., Founder and Chief Scientific Officer, AmProtein Corporation8 Visit www.IBCLifeSciences.com/BPI/US for up-to-date information on this event

Main Conference • Tuesday, October 2, 2007 (continued)12:00 Concurrent Technology WorkshopsDisposable BiopharmaceuticalProcesses – Advances and BenefitsBiopharmaceutical processes require a high investment in capital equipment, which start-upcompanies shy away from either due to financial restrictions and/or drug development risk offailure. However, the need for flexibility and lower investments costs are not only restricted tostart-up companies, but also research organizations with multiple product lines and processparameters or needs in fast track capacity increases. The highest potential to fulfill suchprocess role are disposable technologies, known as already implemented process steps andcompleted by new disposable equipment developments We will review existing disposableequipment and future disposable technologies to be introduced soon. Additionally cases willbe presented, which show the benefits of individual disposable equipment and processes.Maik W. Jornitz, Group Vice President – Product Management, Sartorius Biotech Inc.Multimodal Chromatography –For New and Old Separation ChallengesThe preparation of multi-modal chromatographic media, with thecombinatorial introduction of new interactions, allows an easiermodulation and enhancement of chromatographic performanceas compared to more traditional media. Such approach is particularly effective in thedesign of media with new selectivites and has led to the development of Capto MMCand Capto adhere. Design and application work will be presented.Henrik Ihre, Ph.D., Product Manager, GE HealthcareA Rational Approach to Culture Media Designand Basic Process IntegrationEffective and timely methods are required to successfullymeet product needs during development and ultimatelycommercial manufacture of recombinant therapeutics. Theability to both develop and manufacture high-quality optimized culture media is akey to success. Case studies will be presented to illustrate the use of Rational CultureMedia Design for rapid and effective media and process development.Scott D. Storms, Ph.D., Principal Scientist, Irvine ScientificAdvances in Clone Selection: CloningMedia and Selection Criteria are CriticalClone selection is a key step in cell line development. Recent advances have focused nearlyexclusively on high throughput instrumentation that allow more clones with the desiredphenotypic attributes to be screened, thereby enhancing the ability to find the best producersThis workshop will focus on our experience using the ClonePixFL instrument highlightingboth our development of better algorithms for clone selection, as well as the often overlooked,but critical need to develop appropriate cloning media.Peggy Lio, Process Science Fellow, Invitrogen2:00 Chairperson’s RemarksHoward L. Levine, Ph.D., President,BioProcess Technology Consultants, Inc.2:15 Future of Cell Line and Process DevelopmentMiniaturization and high throughput screening have provento be very powerful tools for the rapid improvement of celllines for antibody production. Productivities in the range of1 g/l to 5 g/l have become achievable for CHO basedproduction. Examples will be given of how these same toolscan be used to improve the speed of process development.The focus on cellline development will increasingly switch to timelines and for this the Pichiabased platform for making antibodies with human glycosylation offers somevery interesting possibilities. Pichia offer two main attractions; the biology isknown in much better detail and the doubling time is several fold shorter.Barry C. Buckland, Ph.D., Research Vice President BioProcess R&D,Merck Research Laboratories3:00 Interactive Panel Discussion on the Future ofDownstream Processing: How Best to Handle HigherBioreactor Outputs and Greater Product DemandsFive experts will present their views on the evolving nature of downstream processing.Each speaker will give his views on how best to make downstream processing robustenough to handle the larger quantities of product produced with increased bioreactortiters, discuss ways to how to make chromatography sufficiently robust and productiveto meet these higher product demands, and also present alternative technologies thatmay replace or supplement chromatography for very large scale recovery. Followingthe brief speaker presentations, audience participation will be encouraged to join thediscussion and share their views on the topic.Moderator:Howard L. Levine, Ph.D., President, BioProcess Technology Consultants, Inc.Panelists:John Curling, Chief Executive Officer, John Curling Consulting AB, SwedenMichael R. Ladisch, Ph.D., Distinguished Professor and Director, Laboratoryof Renewable Resources Engineering, Weldon School of Biomedical Engineering,Purdue UniversityAlan Klotz, Ph.D., Research Advisor, Bioprocess Development,Eli Lilly and CompanyFred Larimore, Ph.D., Director of Scientific Affairs, Cook PharmicaAbhinav Shukla, Ph.D., Associate Director, Manufacturing Sciences,Bristol-Myers Squibb12:30 Networking Luncheon in Exhibit and Poster HallPlenary Session • Tuesday, October 2, 2007Keynote Presentations and Featured Discussion3:45 Networking Refreshment Break in Exhibit and Poster Hall4:15 Regulatory ModernizationThe Center for Drug Evaluation and Research is focusing onachieving the desired state for pharmaceutical productmanufacturing: “A maximally efficient, agile, flexiblepharmaceutical manufacturing sector that reliably produceshigh quality drug products without extensive regulatoryoversight.” Factors include international harmonization, pharmaceuticaldevelopment information, risk management, quality systems, and newtechnologies. This presentation will focus on implementation of the desired stateincluding quality by design with special attention given to biotech products.Helen N. Winkle, Director, Office of Pharmaceutical Sciences, CDER, FDA5:00 Industry Expectations of the NewPharmaceutical Quality Assessment SystemFor industry, utilization of science and risk-basedapproaches to product development should lead to a moreflexible regulatory environment with the establishment of “DesignSpace” and articulating the life-cycle commitments through theRegulatory Agreement. This should in turn lead to a regulatory environmentthat is more amenable to technical innovation. For the regulators, gettingknowledge-rich submissions will help reviewers and investigators gain a thoroughunderstanding of the product and any critical elements and risks associated withthe manufacturing processes and controls. Most importantly, patients will beassured of a continuous supply of high quality medicines.Tobias Massa, Ph.D., Vice President, Global Regulatory Sciences – CMC,Bristol-Myers Squibb5:45 Networking Reception in Exhibit and Poster HallSponsored by5:45-7:00 Dedicated Poster ViewingPoster presenters are asked to be at their posters.10 Visit www.IBCLifeSciences.com/BPI/US for up-to-date information on this event

CO-LOCATEDTuesday, October 2, 2007 (continued)IBC’s 7th AnnualRegister for the Dual Conference Pass and GainAccess to these Conference Sessions and MaterialsFormulation Strategies for Protein TherapeuticsA Case Study and Best Practices Forum Dedicated to Improving the Quality and Speed of Formulation DevelopmentTuesday Highlights Include:• Joint Industry/Supplier Panel: Resolving Characterization, Toxicology and Stability Challenges in Prefilled Syringes and Packaging• FDA Presentation: Risk-based Approach to Assessing the Impact of Extractable and Leachable Substances on Recombinant Therapeutic Protein Products• Case Studies, with topics including Overcoming Challenges of Developing an Alternative Formulation for Lifecycle Management of a CommercialProduct, Rational Design of a Lyophilized Formulation and A Forced Degradation Study Used to Demonstrate Product Comparability Following aManufacturing Process Change• Session on Advances in Stability Analysis, with topics including Predicting Chemical Instability from Protein Sequence, The Role of Bioassay inFormulation Stability Programs and Analysis of Regulatory Stability GuidancesTour Full to Capacity –Currently taking waiting listSITE VISITSTo be put on a waiting list contact customerservice at 800-390-4078.The Cambridge facility is Biogen Idec’s mainclinical production facility operating five2,000 liter bioreactor trains in 3 separatesuites. This is a multi-product facility capableof simultaneously operating three or moredifferent bulk drug substance campaigns. Capacity for the site also includesa licensed cGMP cell banking area. In addition to clinical manufacturing,the Cambridge site is licensed for the commercial manufacture of Avonex,Amevive and Zevalin. The Cambridge Manufacturing group employs over200 people and operates 24 hours per day, 365 days per year.Tuesday, October 2, 2007 from 8:00 am - 12:00 pm. Refreshments andtransportation will be provided. Space is limited.Where does high performance chromatographymedia come from? Take a tour of our manufacturingfacility and see for yourself. Please join us on Wed.Oct. 3, 2007 for a site tour of our state-of –the-art chromatography manufacturing facility.The ISO registered operation which was opened in 2003, was designed for the productionof POROS® Perfusion Chromatography® Media. The 30,000-sq/ft plant is located on theApplied Biosystems campus in Bedford, Massachusetts about 25 minutes from Boston. Thetour will include an overview of the new facility’s design, validation and operation and willprovide a unique insight into the manufacturing process and quality systems used to producehigh performance Protein A, and Ion exchange products for the bioprocess industry.Wednesday, October 3, 2007 from 2:00 pm-5:30 pm. Refreshments and transportation will beprovided. Space is limited.Westborough, Massachusetts site is located 30 minutes from downtown Boston isGEHC’s Life Science center of excellence for crossflow filtration. Visitors will seethe manufacturing and R&D operations for both cassette and hollow fiber productsmanufactured for FDA compliant uses. The technology to manufacture thesefilters results in one of the first examples of industrial scale nanotechnology. Finalassembly of GEHC’s new ReadyToProcess hollow fiber cartridges takes place inthe facilities’ new class 100,000 cleanroom. The pre-rinsed, gamma exposed ready to“plug and play” hollow fibers are part of a series of innovations that are from GEHCWestborough operations. On display will also be Wave Bioreactor and FlexMixer®and other single use innovations. The site produces over 700 different membraneproducts for research, process development and bioprocess customers where ourfilters are used to purify, clarify and concentrate high value proteins .This tour is by invitation only.The PERCIVIA Per.C6®Development Center inCambridge, Massachusetts,a joint venture of DSM andCrucell, develops the Per.C6®human cell platform for theexpression of recombinantproteins. PERCIVIA offers anintegrated technology platform,providing solutions for proteinproduction. The Per.C6® platform encompasses cell line generation technology,cell culture media development, up and downstream design processes, scale-up,technology transfer, and regulatory support. PERCIVIA’s state-of-the-art facilityaffords Per.C6® customers a hands-on experience of the technology.Tuesday, October 2, 2007 from 8:00 am – 12:00 pm. Refreshments and transportationwill be provided. Space is limited.11 To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com

Production & Economics of1 BiopharmaceuticalsScaling Up from Bench2 through CommercializationChoose from these Small GroupDiscussion SessionsSchedule for the following3 Discussion Sessions7:30 Coffee8:00 Co-Moderator’s Opening Remarksand Panel Introductions8:15 Discussion Begins9:45 Networking Refreshment Break inExhibit and Poster Hall10:30 Discussion Resumes12:00 Discussion EndsDiscussion Session 1:Strategies for SmallCompanies Managing LateStage DevelopmentSmaller companies often face a huge challenge whentheir candidate nears commercialization. In earlierstages a smaller number of experienced personnel maybe able to manage their CMO and other providers.How do companies deal with the sudden increasein responsibility, human resource needs, and otherpressures when they are developing a BLA submissionand managing late stage development? Come to thisbrainstorming session to ask your specific questions andhear from others who have been there.Co-Moderators: Tom Ransohoff, Senior Consultant,BioProcess Technology Consultants, Inc.Bob Steininger, Senior Vice President, Manufacturing,Acceleron PharmaFor the following sessions (2A and 2B), participation is limited to30 people for each topic on first come first served basis. Facilitatorswill introduce each topic, and small workgroups will collaborate toconsider in-depth hypothetical exercises. The groups will then eachpresent a summary of their tables' perspectives to the room.Discussion Session 2A:Modeling Up and Scaling Down:Use of Model Systems inValidation AssuranceModeling Up and Scaling Down: Use ofModel Systems in Validation AssuranceThis session will examine acceptable and unacceptable usesfor data derived from lab, pilot, or commercial scale modelsand experiments in assuring validity of routine commercialoperations. Groups will discuss realistic but hypotheticalscenarios. Participants will share whether the scenariopresented would be acceptable practice in their organizations,why their organizations would take this position, andwhether the currently accepted practices are evolving.Facilitators:Jeffrey C. Baker, Ph.D., Senior Research Advisor,Eli Lilly and CompanyJohn Finkbohner, Ph.D., Associate Director, RegulatoryAffairs, Vaccines, MedImmune, Inc.Main Conference • Wednesday, October 3, 20077:15 Technology WorkshopPlease visit website for updatesCell Culture &3 Upstream ProcessingRecovery & Purification4Session Sponsor:7:30 Coffee8:00 Session Sponsor's IntroductionKathie Fritchman, Manager, Bioprocess Application– Advanced Bioprocessing, BD Biosciences8:05 Chairperson’s Opening RemarksDennis M. Kraichely, Ph.D., Principal ResearchScientist, Pharmaceutical Development,Centocor R&D, Inc.Early Stage Process Development- Getting to Clinic Faster8:15 CHO BI-HEX - A UniqueImprovement Platform thatSecures Fast Time to ClinicMost biopharmaceuticals are currently expressedin Chinese hamster ovary (CHO) cells. Processdevelopment faces at least two challenges: (i) theneed to achieve high product titer at and (ii) shortdevelopment times to obtain clinical grade material.Boehringer Ingelheim’s high expression BI HEXcell line generation concept will be presented thatcombines many improvements including uniquegenetic elements, HTS concepts to reliably obtainhighly productive clones that grow to high densityin serum-free chemically defined media withproductivities > 50 pg/cell/d and product titers of4g/L in a 11-day fed-batch process for mAbs.Torsten W. Schulz, Ph.D., Associate Director, CellCulture Technology, Biopharmaceutical ProcessScience, Upstream Development, BoehringerIngelheim Pharma GmbH & Co. KG, Germany8:45 Behavior of GS-CHO Cell Lines ina Selection StrategyTransfection of mammalian cell lines generatesa population with heterogeneous growth andproductivity characteristics. Cell lines with thedesired characteristics must be isolated fromthis heterogeneous population. Strategies forimproving the ‘hit rate’ of identifying ‘good’manufacturing cell lines will be discussed.Alison Porter, Ph.D., Senior Scientist, CellCulture Process Development, Lonza Biologics,plc, United Kingdom9:15 A Platform Strategy for FastDevelopment of High-ProducingNS/0 Production Cell Lines inAnimal Protein Free MediumA platform has been established for fast and efficientdevelopment of NS/0 production cell lines. Thisapproach can generate several thousands cloneswith high cloning efficiency in animal protein free(APF) medium, within a short timeframe. Theshort duration for the cell line development helpsreduce the time to submit the initial IND. Thecomprehensive selection process ensures that the finalcell line has high (multiple grams/L) productivity andacceptable product quality and phenotypic stability.This presentation summarizes the key elements ofthe platform for the development of NS/0 cell linesin APF medium, including adaptation of cells to APFmedium, single cell cloning as well as the criteria forselection of the final clone that includes evaluation ofcell line stability and product quality.Jianguo Yang, Ph.D., Scientist/ Group Leader,Cell Line Development Group, Process CellCulture Department, MedImmune, Inc.7:30 Coffee8:00 Chairperson’s Opening RemarksEdward Cole, Ph.D., Senior Vice President,Protein Development, Genzyme CorporationFeatured Presentation8:15 Lessons Learned andNot – Future Directionsin ChromatographyProcess chromatography has a50 year history with majortransitions from the art of purification tothe science and technology of downstreamprocessing. New developments need to exploitthe potential of computer and material scienceswith engineering in a holistic approach tochromatographic unit operations. The barriersbetween membrane and bead technologiesneed to be removed.John Curling, Chief Executive Officer, JohnCurling Consulting AB, SwedenNext Generation / DisruptivePurification Technologies8:45 Self-Cleaving Inteins andAffinity Resin Substitutes forNon-Chromatographic ProteinPurificationTwo novel methods are reported for the nonchromatographicpurification of recombinantproteins. Both methods rely on self-cleaving,self-aggregating purification tags, where thetarget protein is recovered and purified usingsimple, mechanical solid-liquid separations.These methods have been very successful inE. coli and in principle will be applicable to awide range of expression systems and productsat large scale.David W. Wood, Ph.D., Assistant Professor,Chemical Engineering, Princeton University9:15 Design Optimal Process CaseFlow Platforms for StudyMonoclonal AntibodyDownstream PurificationManufactureThe increasing high IgG titer from mammaliancell fermentation and advanced analyticaltechnologies for various impurities andcontaminants characterization starts to reshapemAb downstream purification strategies.Besides the efforts on developing individual highcapacity and high resolution chromatographyprocess, we also studied process platform flow.Three new platform designs involving MEPand CHT offer several distinctive advantages toimprove overall DSP efficiency.Jie Chen, M.D., M.S., Associate Director,Process Sciences, Dyax Corp12 Visit www.IBCLifeSciences.com/BPI/US for up-to-date information on this event

Main Conference • Wednesday, October 3, 2007 (continued)Production & Economics of1 BiopharmaceuticalsScaling Up from Bench2 through CommercializationDiscussion Session 2B:Quality by Design:Aspiration and ApplicationQuality By Design: Aspiration andApplicationThis session will examine similarities and differencesbetween developing industry perspectives on Qualityby Design and actual current and anticipated practice.Participants will discuss how the scenarios providedwould be handled by their current regulatory and qualityorganizations and how they might be managed indeveloping Quality by Design "future states".Facilitators:Jeffrey C. Baker, Ph.D., Senior Research Advisor, Eli Lillyand Companyand Eric C. Jensen, Ph.D., Senior Regulatory Fellow, CMCRegulatory Affairs, Eli Lilly and CompanyDiscussion Session 3:The Impact of Evolving ProcessCapabilities and Adaptationson FacilitiesPanelists will analyze several scenarios of how facilitiescan adapt to accommodate varying quantities ofproducts being manufactured, increasing upstreamtiters, changing downstream schemes and differentproducts within a facility. Change-overs, automation,batch records and other related topics will be discussed.Process development and manufacturing scientistsand engineers will benefit from the discussion, tobetter understand how process development and newtechnologies impact manufacturing facilities. Input shallbe provided to the audience based on currently available,practical, technical solutions. Panelists will give briefintroductory remarks followed by an audience interactivepanel discussion.Co-Moderators:Dr. Günter Jagschies, Director R&D, CustomerApplications,GE Healthcare Bio-Sciences, SwedenAlex Fotopoulos, Director of Engineering, Biogen IdecPanelists:Kevin Hanley, Director of Pilot and ClinicalManufacturing Operations, WyethEd Goudreau, Senior Director, Manufacturing,Biogen IdecCell Culture &3 Upstream ProcessingRecovery & Purification49:45 Networking Refreshment Break inExhibit and Poster Hall10:30 Therapeutic Antibody ProductionCell Line Development with anImproved Selection Process andAccelerated TimelineWe explored a stringent selection method usinga novel vector in which the selection marker islinked to the antibody gene. By increasing themethotrexate (MTX) concentration, we are able toget good producers by screening fewer clones sincethe low producers could not survive this stringentselection. Clones from this one step approach haveprovided us PhaseI/II lines. To further shortenthe timeline, a complete serum-free transfectionand selection approach was explored. Since thewhole process is totally serum-free, there is notime needed for serum-free adaptation. Therefore,the timeline from transfection to banking of thetop clones is further shortened to 3.5 months. Thisplatform is used at Genentech to produce the PhaseI/II stable cell lines.Amy Shen, M.S., Scientist, Early Stage CellCulture, Genentech, Inc.11:00 Fluorescent Protein A/G BasedAntibody Secretion Detection AssayWe have developed a novel fluorescent assayto selectively identify and isolate clones thatexpress high-levels of recombinant protein. Cellsexpressing recombinant antibody are plated ina semisolid methylcellulose matrix containingfluorescent Protein A or Protein G and screenedfor fluorescence intensity. Total fluorescence of cellsurface and immediately surrounding each colonyhas been shown to be directly proportional to theamount of secreted protein. A strong correlationbetween total fluorescence intensity and volumetricproductivity has been observed (R2 = 0.74). Furtherstudies have now shown that this procedure workswell for selection of newly transfected parental celllines and sub-clones. Some advantages of this newscreening method will be presented.Sunil Mehta, B.Pharm., Ph.D., ResearchScientist, Pharmaceutical Development,Centocor, Inc.11:30 Suspension of DNA Mismatch RepairAllows for the Isolation of CHO CellsResistant to High OsmolarityWhen DG44 CHO cells are shifted fromiso-osmotic to hyper-osmotic conditions, asurviving population emerges after severalweeks. Is resistance to high osmolarity acquiredby genetic selection or metabolic adaptation?Application of Invitrogen’s REVOLUTIONtechnology has provided interesting insightsinto this question and others, for engineeringnew cell lines for bioproduction.Florence Wu, Ph.D., Director, Process Sciences,PD-Direct, Invitrogen9:45 Networking Refreshment Break inExhibit and Poster Hall10:30 Development of a Low pH CellRemoval and its Scale up to 10KLScale for Large-Scale AntibodyManufacturingA low pH cell removal procedure wasdeveloped at PDL to overcome difficulties ofhigh cell density and low viability cultures.It greatly increases microfiltration flux andcapacity; dramatically reduces depth filtrationsurface area post centrifugation. The methodhas been applied to many antibody candidatesat PDL and scaled up to 10 KL scale. Thedevelopment, optimization, and scale upexperiences will be presented.Ping Y. Huang, Ph.D., Associate Director,Process Sciences & Engineering,PDL BioPharma11:00 Charged Membranes andMonoliths in ChromatographySingle-use adsorptive membranes andmonoliths are inherently fit for capture ofbiomolecular impurities such as DNA, hostcellprotein, endotoxin, and viruses, and canachieve a much greater volumetric throughputthan traditional chromatography columnspacked with beads. In this work, we investigatethe use of strong anion exchangers for clearanceof pathogenic impurities and develop ascientific basis for practical implementation.Mark R. Etzel, Ph.D., Professor,Chemical and Biological Engineering,University of Wisconsin11:30 New Stationary Phases inChromatographyThe past few years have seen considerableactivity in the development of new stationaryphases for chromatography. These haveincluded new functionalities such as mixedmode chemistries and new chromatographyformats such as membrane chromatography.New stationary phases offer the opportunityto increase process efficiency and robustness.Process applications of new stationary phasesand their development requirements will bereviewed.John Liddell, Ph.D., Head of Process Science,Avecia Biologics, United Kingdom“An excellent conference for people in the biotech industry. There is a vast database of experience,very good quality of work that is presented and excellent energy during the conference sessions.”- Seshu Tyagarajan, Senior Manufacturing Team Leader, Biopharmaceuticals, Hoffmann-La Roche13 To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com

Main Conference • Wednesday, October 3, 2007 (continued)12:00 Concurrent Technology WorkshopsCell Xpress Technology Facilitates High-Producing Chinese Hamster Ovary Cell LineGeneration Using Glutamine SynthetaseGene Expression SystemCell Xpress is a powerful alternative to traditionalclone selection approaches. It uses the LEAP(Laser-Enabled Analysis and Processing) technologyplatform to identify, purify and monitor expansion ofindividual clones that secrete monoclonal antibodies.This presentation focuses on using both Cell Xpressand media formulation screening to generate highproducingclones using the Lonza glutamine synthetase(GS) gene expression system.Genova A. Richardson, Research Scientist, Cell LineEngineering, SAFC BiosciencesPOROS® Chromatography Media:The Fix for Your DownstreamProcess BottleneckThe features and benefits of POROS® chromatographymedia as they relate to improving downstreampurification process productivity will be discussed.Performance benchmarking of the NEW MabCaptureA rPA affinity media and other POROS medias will behighlighted. Process productivity modeling will be usedto demonstrate the benefits of utilizing POROS mediafor purification unit operations.Christine Gebski, M.S., Applications Manager,Applied BiosystemsSequential Multi-ColumnChromatography – Enabling ContinuousDownstream ProcessingA unique approach to continuous chromatography,when applied to single unit process operations(SMCC) promises impressive gains in productivity.More significantly, as the solution to the challenge ofcontinuous chromatography, SMCC is the technologythat can unite individual DSP unit operations into asingle continuous downstream process. We will presentinformation on the SMCC product, economic modeling,ease of installation and operation.Stephen K. Tingley, BSc, Vice President Sales &Marketing, Novasep Process12:30 Networking Luncheon in Exhibit and Poster HallProduction & Economics of Cell Culture &Recovery & Purification1 Biopharmaceuticals 3 Upstream Processing 4Scaling Up from Bench1:45 Chairperson’s RemarksOvercoming the Challenges of2 through CommercializationKevin J. Kayser, Ph.D., R & D Manager, Cellthe Ton Scale ProcessSchedule for the following 2Discussion Sessions1:45 Discussion Begins3:30 Networking Refreshment Break andLast Chance for Poster and ExhibitViewing4:15 Discussion Resumes5:30 Discussion EndsDiscussion Session 4AMaking the Connection: Howto Hire, Train and Retain TalentAs the Bio-Pharmaceutical industry continues tochange and evolve due to increasing competition andmarket growth, a company’s staffing needs becomemore challenging.What is the most successful way to juggle multiplecandidates, timing and the interviewing process? Whatare the “Best Practices” employed by your competitorswith regard to development and retention? Learnhow to court top-tier scientists, maximize your hiringbudget, develop individualized development plans, givefeedback, coach, mentor, and finally, reward the talentyou have worked so hard to attract.Megan Driscoll and Lisa Prior, leaders in executiverecruiting and management consulting, offer conferenceattendees their expertise on what strategies are themost effective to successfully hire, train and retaingreat talent in a dynamic and competitive job market.Individual break-out discussions may be developedupon request.Megan Driscoll, President, PharmaLogics RecruitingLine Engineering, SAFC Biosciences2:00 Differential Expression Profilingof Industrially Relevant CHO CellPhenotypes Using a ProprietaryCHO-Specific Microarray andProteomics Technology PlatformsLarge and diverse sets of CHO cell samples,which embodied several industrially relevantphenotypes, were interrogated using aproprietary CHO-specific oligonucleotidemicroarray, as well as proteomics technology.Key learnings and insights resulting from theanalysis of samples representing 29 differentrecombinant CHO cell lines expressingmonoclonal antibody, receptor-Fc fusionmolecules, coagulation factors or growthfactors will be presented.Martin S. Sinacore, Ph.D., Associate Director,Cell & Molecular Sciences, Wyeth BioPharma2:30 Mammalian Cell CultureMonitoring and Control byAutomated Flow CytometryAn automated flow cytometry system hasbeen developed to better understand howculture heterogeneity changes over time. Theobserved dynamics provides the basis for new,innovative process control strategies for scalingup cell cultures. The approach is in accordancewith the PAT initiative aimed at producingmore reliable products on the basis of bettercontrol and understanding of the biological–pharmaceutical manufacturing process.Friedrich Srienc, Ph.D., Professor,Chemical Engineering and Materials Scienceand The BioTechnology Institute,University of Minnesota1:45 Chairperson’s RemarksBrian R. Hubbard, Ph.D., Scientific ExecutiveDirector, Process and Analytical Sciences,Amgen2:00 Options to Overcome theCurrent Challenges inDownstream ProcessingThe enormous success of mammalian cell cultureto reach very high titers specifically with “normal”monoclonal antibodies has raised attention tothe next bottleneck in Biotech Manufacturing.There are at least two different drivers to addressthe challenges in downstream. One is morefacility related, the other more protein handlingrelated. Dependent on the situation a numberof different solutions can be projected at least ina foreseeable time. These in turn may still servefor only a certain time and a new set of potentialconstrains or designs will arise. The currentlyperceived challenges and the extrapolation ofsome solutions will be discussed.Wolfgang Berthold, Ph.D., Chief TechnicalOfficer, Technical Development, Biogen Idec2:30 Purification Process Developmentto Increase Capacity in an ExistingManufacturing FacilityLimited manufacturing capacity and highproduct demands have driven the needto produce and purify ever larger bulkmasses with minimal changes to existingmanufacturing facilities. This talk will exploreefforts to design MAb purification processesto increase the recoverable titer in an existingmanufacturing facility.Christopher Teske, Ph.D., Engineer II, Late-Stage Purification, Genentech, Inc.14 Visit www.IBCLifeSciences.com/BPI/US for up-to-date information on this event

Main Conference • Wednesday, October 3, 2007 (continued)Production & Economics of Cell Culture &1 Biopharmaceuticals 3 Upstream ProcessingRecovery & Purification4Scaling Up from Bench3:00 20g/L and Beyond:Case 3:00 Novel Technologies for Processing2 through Commercialization Development of Advanced StudyHigh Volumes in DownstreamExpression Solutions for theManufacturingManufacture of BiopharmaceuticalsThe production of large proteins, monoclonalDiscussion Session 4BThis presentation will describe how anantibodies, and some vaccines result in largeBuilding the Biomanufacturingunderstanding of the expression kinetics ofvolumes of dilute solutions containing targetexisting vector systems currently considered ‘statemolecules in complex media. The processingEducation and Trainingof the art’ was used to aid the design of advancedof these streams to maximize recovery ofInfrastructure‘broad host range’ systems (e.g. prokaryotic, yeast,product from molecules that foul or interferemammalian). This coupled with the developmentwith subsequent separation steps requiresof platform technology encompassing host,novel capture, membrane, and post-separationgrowth medium, fermentation system hasprocessing steps. Novel technologies,provided a significant advance in reducing processrobustness, and scale-up will be discussed.development times and achieving high levelMichael R. Ladisch, Ph.D., Distinguishedproductivity. Solutions will be exemplified usingProfessor and Director, Laboratory ofcase studies demonstrating the high level microbialRenewable Resources Engineering, Departmentproduction of a wide range of therapeuticallyof Agricultural and Biological Engineering,useful proteins (vaccines, cytokines, growthWeldon School of Biomedical Engineering,factors, etc) in soluble (cytoplasmic and periplasm)Purdue Universityand insoluble (inclusion body) form.Bo Kara, Ph.D., Director, Science and3:30 Networking Refreshment Break and LastTechnology, R&D, Avecia BiologicsChance for Poster and Exhibit ViewingIn 2005, the National Science Foundation funded anAdvanced Technological Education BiomanufacturingCenter. The purpose of the NBC2 is to• work with local biomanufacturers to develop a pipelineof biomanufacturing workers and a biomanufacturingcareer pathway for high school graduates throughBiomanufacturing Apprenticeships;• support professional development for faculty teachingbiotechnology/biomanufacturing, including a GlobalBiomanufacturing Curriculum Repository for depositingand withdrawing biomanufacturing curriculum,instructional materials and resources;• provide a public awareness of biotechnology/biomanufacturing careers.With biomanufacturers and educators workingtogether we hope to provide an appropriately outfittedbiomanufacturing workforce to support the expansion ofbiopharmaceutical manufacturing and the development ofa local, regional, national and global bioeconomy.Sonia Wallman, Ph.D., Director of Biotechnology and theNortheast Biomanufacturing Center and Collaborative(NBC2), a National Science Foundation AdvancedTechnological Education Biomanufacturing Center, NewHampshire Community Technical CollegeDiscussion Session 5Publishing with BPIFor readers and prospective authors interested incontributing to BPI, the editors (and an editorial advisoror two) present this workshop overviewing manuscriptpreparation, review, revision, and copyediting. Whatdetermines a "focus-on" article from a technical paper froma "vendor voice?" How can you be sure your topic is a goodone for the BPI audience? What are the most commonmistakes made in manuscript preparation? How do yourespond to critiques? What's the difference between BPIand an academic journal? Attend to find out how to bepublished in BioProcess International.CO-LOCATED3:30 Networking Refreshment Break and LastChance for Poster and Exhibit Viewing4:00 Development of High ProteinProducing Cell Lines fromHybridoma Clones UsingLentiviral VectorsA critical concern for national defense is the abilityto quickly and accurately detect biological agentsthat could be potentially used as biological warfareand terrorism. Detection devices require the useof reagents, such as antibodies, as a means ofidentifying a particular agent by its distinguishingcharacteristics. One of the biological agents ofmost concern is Bacillus anthracis, the causativeagent of anthrax. To meet this detection capabilityrequirement, monoclonal antibodies ( mAbs) thatbind specifically to spores of Bacillus anthracis weredeveloped under a Technology Transition Program.The resulting hybridoma cell lines produced mAbsranging from 29 mg/3L supernatant to 600 mg/3Lsupernatant. The mAbs were sent to outside labs fortesting and it was determined that clone JC8-5-1, alow producer, showed high specificity in diagnosticapplications. Since attempts to mass produce thisantibody have been unsuccessful, JC8-5-1 waschosen as a model hybridoma cell line for cell linetransduction and protein production.Darrel Menking, Ph.D., Senior Scientist,AMSRD, Edgewood Chemical Biological Center(ECBC), US ARMYRegulatory Guidance, Validation& Viral Clearance4:00 Evaluation of Process and ProductImpact of UVC Treatment on amAb ProcessShort wavelength ultraviolet (UVC) light is aneffective virucidal treatment. Application tobiotherapeutics has the potential to provide arobust orthogonal viral clearance mechanism.We investigated the impact of UVC treatment ona monoclonal antibody process with respect toprocess performance and product impact. Thestudy results will be discussed and a robust 3 stepviral clearance platform strategy proposed.R. Scott Rosenthal, Ph.D., Senior Scientist,Purification Process Development, Amgen Inc.IBC’s 7th Annual Formulation Strategies for Protein TherapeuticsA Case Study and Best Practices Forum Dedicated to Improving the Quality and Speed of Formulation DevelopmentWednesday Highlights Include:• Current Scientific Understandings of Protein Behavior in High Concentration Protein Solutions• Small Group Scientific Exchange Discussions: Interactive Hypothetical of Resolving AggregationProblems in Formulating a High Concentration Antibody Product• Integrating Quality by Design Principles in the Formulation Function• Optimizing the Relationship between Drug Product Formulation and Process DevelopmentRegister for the Dual ConferencePass and Gain Access to theseConference Sessions and Materials15 To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com

Cell Culture &3 Upstream ProcessingRecovery & Purification4:30 Secretion of Antibody Fragments and Target-BindingProteins with E. coliSecretion from E. coli into the culture broth is a unique feature and cuts downon manufacturing costs in down stream purification. Wacker has developed atechnology for efficient high level secretion of recombinant proteins from E. coliK12. This secretion technology is successfully used for technical applications ona 4000 L scale with yields of up to 7 g/l protein product in the culture broth. Thistechnology can also be applied for biologics manufacturing and a yield of 5 g/l ofa therapeutic protein has already been achieved. The presentation will focus oncase studies that showed that the expression system is also highly efficient for theproduction of antibody fragments and other binding proteins. It even proved tobe an enabling technology in the case of a lipocalin protein.Susanne Leonhartsberger, Ph.D., Head of Project Management, WackerBiotech GmbH, Germany5:00 Evaluation and Impact of Hydrolysates on ProductionYield ImprovementWhile chemically defined medium is the medium of choice it is often thecase that production yield is limited or even lessened with such lean media.With proper understanding of hydrolysates and their properties, increasedyields with consistent performance can be obtained. Multiple non animalhydrolysates are now available that work well with most cell types and highyields can be obtained with proper screening techniques.David Chang, Ph.D., Director of Process Development, Genentech, Inc.5:30 Implementation of High Throughput Systems for Mediaand Process DevelopmentSeveral high throughput (HTP) technologies are needed to accelerate processdevelopment within biotherapeutic manufacturers: 1) HTP assays duringoptimization, 2) HTP clone selection tool (e.g., ClonePixFL), 3) design ofexperiment (DOE) strategy, 4) liquid handler (e.g., Hamilton STARplus),5) HTP growth platforms (e.g., multi-well plates, micro-bioreactor arrays(MBA) of SimCell system), and 6) database to track, store and query. We willdescribe our approach to using these tools as well as problems encounteredand solutions implemented.Steven C. Peppers, Ph.D., Principal Scientist, Invitrogen Corp.6:00 Close of Day ThreeMain Conference • Wednesday, October 3, 2007 (continued)Share your research by presenting a poster at this event. This is a greatopportunity to discuss your findings and field questions from interestedattendees.• One poster award winner from each conference track will receivea $150 awardand certificate• Space is limited to 75 posters• Posters will be displayed by conference track• Dedicated poster viewing times scheduled in the exhibit hall• 15 poster abstracts will be published in a special event preview• Visit www.IBCLifeSciences.com/BPI/US for more informationWe are currently accepting poster abstracts in the following topics:Cell Culture • Recovery & Purification • Production &Economics• Scaling Up From Bench to ClinicSponsored by:16 Visit www.IBCLifeSciences.com/BPI/US for up-to-date information on this event44:30 A Novel Procedure for Validation ofCaseAdventitious Virus Removal from aStudyMonoclonal Antibody ProcessIt is an expectation of regulatory bodies globally that downstream processesdemonstrate robust clearance of model adventitious viruses prior to licensure. Auseful step employed in numerous purification processes is the use of viral filtration.To demonstrate the capability of this unit operation a representative feedstock isspiked with a preparation of model virus, the feedstock is passed through the filter,and the viral clearance is determined after measuring recovered levels in the filtrate.Due to the relatively high level of impurities in the viral spike in comparison to thenon-spiked feed, a significant degradation in the volumetric capacity of the virusfilter is commonly observed when processing a spiked load in comparison to nonspiked.This raises the question of whether virus filter sizing for routine processingshould be based on the capacity as determined with non-spiked feed or the morelimitedcapacity obtained with a spiked feed during process validation (which, inmost cases, is significantly smaller). In this presentation, we will present a novelprocedure for approaching the validation of adventitious.Yaling Wu, Ph.D., Senior Scientist, Process Development, Human GenomeSciences, Inc.5:00 The Importance of Virus Spike PreparationVirus spikes are required for demonstrating clearance. High virus titer spikes arepreferred to obtain higher log reduction values (LRV). Currently, there is no standardfor preparation of virus spikes, and sponsors may find variability in clearance studiesdue simply to the virus preparation methods. Some important factors include theaddition of proteins or other stabilizing agents to maintain virus viability, freezing andthawing of virus stocks, and virus titration methods. These factors and other relevantissues will be discussed. The current status of the PDA Technical Report on virusspike preparation will be presented.Gail Sofer, M.S., Director, Regulatory Compliance, GE Healthcare5:30 European Draft Guideline on Virus Safety Evaluation ofProducts in DevelopmentThe draft guideline on virus safety evaluation of biotechnological investigationalmedicinal products was released by CHMP for consultation in June 2006.Although the consultation phase ended on 31st December, 2006, a finaldocument or a revised draft has not yet been published. The requirements of theproposed guideline will be discussed and critical points illustrated.Hannelore Willkommen, Ph.D., CEO, RBS Consulting, Germany6:00 Close of Day ThreeCall for Poster SubmissonsSubmit your abstract online today at www.IBCLifeSciences.com/BPI/USAbstracts and all conference and poster fees must be received by July 25, 2007 for inclusion in the BioProcess International Show Preview andConference CD-ROM. After July 25, 2007, abstracts and all conference and poster fees must be received by September 7, 2007 for inclusion inthe Conference CD-ROM and to receive your poster assignments.Poster and Exhibit Viewing HoursMonday, October 1, 2007 5:30 pm – 7:00 pmTuesday, October 2, 2007 9:45 am – 7:00 pmWednesday, October 3, 2007 9:45 am – 4:00 pmDedicated Poster ViewingTuesday, October 2, 2007 5:45 pm – 7:00 pmPoster presenters are asked to be at their posters during this time.Poster Award PresentationWinners will be announced in the December issue of BioProcess International.Abstracts submitted for poster presentations will be reviewed on the basis ofscientific merit, novelty and practical application. All accepted poster abstracts willbe included on the conference CD-ROM and in addition, abstracts of the highestrelevance to bioprocessing research will be published in a special event preview. Posterpresentations can not be used as exhibit displays or for marketing purposes. Posterabstracts must be submitted online at www.IBCLifeSciences.com/BPI/US . Please note:to be included on the CD-ROM and event preview, you must be registered for theconference by September 7, 2007. Size of the conference posterboard is 4’hx 8’w. Onlyone poster presentation will be allowed per registered attendee/author.

Main Conference • Thursday, October 4, 2007Cell Culture & Upstream ProcessingRecovery & Purification3 47:30 Coffee8:00 Chairperson’s Opening RemarksLaurel Donahue-Hjelle, Ph.D., Director of Cell Line Development,Invitrogen CorporationLate Stage Process Development –Improving Yield and Quality8:15 Strategies for Changing Cell Lines and/or ProcessesDuring Late Stage DevelopmentSpeed is most critical in early development while yield is most critical inlate stage development. The yield of fast cell line and process developmentplatforms used in early phases often is insufficient for efficient late stage ormarket production. Strategies including a cell line and process switch cankeep the timelines short for early development and the yield high for latestage development but are associated with the additional efforts and cost forthe generation of a second cell line. Therefore, an ideal cell line developmentplatform combines speed, that allows fast early phase development, with ayield, that is sufficient for market production. Some aspects of improving ourplatform towards high yielding fast processes will be presented.Thomas Jostock, Ph.D., Principal Scientist Biotechnology Development, Celland Process R&D, Novartis Pharma AG, Switzerland8:45 Industry Perspective on Reducing Lot-to-LotHydrolysate VariabilityHydrolysates are still widely used in clinical and commercial manufacturingprocesses, primarily to enhance yield. They can have a profound influenceon the overall performance of the process and even some product qualityattributes. Controlling the quality but also the supply of this often criticalraw material becomes important for every company that has high volumecommercial products. We will present some case studies leading into a paneldiscussion to illustrate that today’s hydrolysate business will only continue ifsuppliers and customers start working together and share data to understandthe cause and effects of the entire hydrolysate manufacturing process to thedrug manufacturing process.Thomas Seewoester, Ph.D., Director, Process Development, Amgen Inc.9:15 Panel DiscussionReducing Hydrolysate Variability –Perspectives from the SuppliersModerator:Thomas Seewoester, Ph.D., Director, Process Development, Amgen Inc.Panelists:Kathie Fritchman, Manager, BioProcess Application - AdvancedBioprocessing, BD BiosciencesEd van der Ent, Ph.D., Product Transition Manager, DMV InternationalShawn R. Smith, Global Market Director, Cell Nutrition, Sheffield PharmaIngredients, Kerry Bio-Sciences9:45 Networking Refreshment Break10:15 Development of a Robust Small-Scale ProductionFormat that is Predictive of Bioreactor PerformanceA small-scale fed-batch culture model system has been developed andshown to be a reliable predictor of pilot and production-scale bioreactorperformance. The parameters that influence the growth characteristics insmall-scale systems were determined and addressed. The resulting formatis flexible and simple to operate, and allows for good sample throughput,making it compatible with rapid cell line development timelines.Gene W. Lee, Principal Research Scientist II, Cell & Molecular Sciences,Wyeth BioPharma7:30 Coffee8:00 Chairperson’s Opening Remarks: Disposables inChromatography – The Good, the Bad, and the UglyUwe Gottschalk, Ph.D., Vice President, Purification Technology,Sartorius AG, GermanyImproving Downstream Economies and Efficiencieswith Disposables, Platforms and Quality by Design8:15 The Role of Primary Recovery TFF in Non-Affinity CasePurification Schemes for HuMab Production StudyIn the development of non-Protein A purification platform technologies,primary recovery TFF for concentration & buffer exchange plays a crucialrole. Feed conditioning below neutral pH for cation capture chromatographycan be obtained by buffer exchange at TFF stage. This filtration step notonly results in reduction of batch volume and processing time but alsoprovides partial purification by lowering host cell contaminants. In addition,HuMabs are generally more stable in buffer exchanged bulk conditions thanin cell culture supernatant. Therefore, TFF bulk stage can be a convenientintermediate hold step and allows flexible schedules for multiple capturecycles in large scale manufacturing. HuMab case studies will be presented.Jue “Michelle” Wang, Ph.D., Senior Manager, Purification ProcessDevelopment, Medarex8:45 Application of Platform Technologies inDownstream Development: Benefits and Limits17 To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.comCaseStudyYield and speed are two major drivers for development of down-streamingprocesses. Increased expression levels (above 2-4 g/L) of therapeutic monoclonalantibodies have significantly increased the challenge for downstream processingwith respect to process economy and process robustness. Case studies arepresented demonstrating significant improvements and limits with respectto purity, process times, buffer volumes and yield. Finally, new concepts foroptimization and acceleration of process development by establishing BI´sautomation platform (RAPPTor®) are addressed.Dorothee Ambrosius, Ph.D., Director, Downstream Development, ProcessScience, Boehringer Ingelheim, Germany9:15 Impact and Benefits of Applying Quality by Design(QbD) inCell Line Development to Downstream Process DevelopmentAmgen has developed expression platforms to expedite and streamline processesleading to clinical manufacturing. A highly effective CHO cell stable expressionsystem and automated processes have allowed Amgen to expedite preclinical andclinical development. At the same time as cell line development is being platformed,process development needs to bear in mind the QbD and product comparabilityaspects for later phase studies and commercialization. The ease of developing arobust cell culture and purification process that consistently delivers the criticalproduct quality attributes depends in part on the recombinant protein and the cellline. The prescreening methods used to predict potential process developmentproblems for candidate molecules and the use of screening processes to evaluatekey product quality attributes will be discussed. We will also illustrate how we applyaspects of QbD to clone selection to minimize product micro heterogeneities andisoforms using small scale cell culture models to streamline our expression platformfor titers and product quality while accelerating speed to clinic.Pranhitha Reddy, Ph.D., Scientific Director, Process and Analytical Sciences,Amgen Inc.9:45 Networking Refreshment Break10:15 BioSMB: Scaled Down MAb Capture in aDisposable-Format Continuous, Multi-ColumnChromatography ProcessCaseStudyThe downstream processing bottleneck is leading to the exploration ofgreater effiiciencies. BioSMB is a technology that refines traditional SMB, viadisposable components, into a viable option biopharmaceutical purification.This talk will present data of a MAb downstream process using a 'PD scale',50L bioreactor to a scaled down BioSMB system. The PD data suggests thatBioSMB will show unique benefits at large scale including reduced buffer,WFI and media consumption, semi-continous processing, high cycle rateand overall greater manufacturing efficiencies as well as flexibility (disposablecolumns, valves and sensors). The data set includes an economic projection tolarge (5000L to 20,000L) scales using data from the PD scale.Marc Bisschops, Scientific Director, BioProcess, Tarpon Biosystems

Main Conference • Thursday, October 4, 2007 (continued)Cell Culture & Upstream ProcessingRecovery & Purification3 410:45 Topic and presenter to be determined11:15 The Application of Root Cause Analysis andInvestigational Tools to Identify and Resolve CellCulture Issues Observed at Commercial Scale duringTechnology TransferUnexpected cell culture performance was observed during the transfer and scaleup of a commercial scale process to 15,000L. This presentation discusses theapplication of root cause analysis and investigational tools to identify and resolvethe process issues. The investigational tools include multivariate data analysis,computational fluid dynamics, bench and pilot scale evaluation.Kenneth Green, Ph.D., Principal Scientist, Amgen Inc.11:45 Concurrent Technology WorkshopsNext Generation Process Control10:45 A Systematic Approach for Process Improvementvia Process Data Analysis: Example for ImprovingUFDF Recovery EfficiencyCaseStudyIn a biological manufacturing process, a large number of process variables are typicallymonitored. These data can be used to increase process efficiency and improve stability.In this work, an approach is presented to systematically analyze process data forimproving the efficiency and operation consistency of an ultrafiltration/diafiltration(UFDF) process step which is used to concentrate a purified protein product.Michael J. Bartkovsky, Ph.D., Process Engineer, BioPharma Group, BayerTechnology Services, Bayer Corp.11:15 Process Characterization during Development and ValidationDriven by competitive and regulatory compliance demands, there is increasingemphasis to optimize including process identification, process validation, processcontrol, and process improvement throughout process development. Thispresentation describes statistical techniques that are used to identify critical processcharacteristics. Topics include design of experiments and analysis of variance.Steven Walfish, M.S., President, Statistical Outsourcing ServicesProcess Optimization Using Peptones – CaseStudies Demonstrating Increased PerformanceWith Peptone Blends and Feed StrategiesOne of the most important factors in any production processis the selection of an appropriate base medium that is coupledwith an effective feed strategy. Animal Free peptones havebeen successfully used to achieve increased production levelswith minimal cost and timeline requirements. Several casestudies will be shown in this presentation where significantproduction improvements were achieved through the use ofpeptone blends or an appropriate peptone feeding strategy.Stacy Holdread, M.S., Senior Scientist, R&D, BDBiosciences – Advanced BioprocessingAbstract and speaker nameunavailable at press time.Please visit www.IBCLifeSciences.com/BP/USfor program updates.Preview of a Novel and Robust Viral Clearance Solutionfrom MilliporeThis workshop will provide a preview of Viresolve® Pro, a novel virus clearancesolution under development at Millipore. It combines a high capacity/highflux virus filter with a high level of parvovirus retention and novel intergritytesting technology. Case studies will be presented, with virus clearance resultsthat demonstrate the anticipated performance of Viresolve Pro devices. Thisinformation is critical for process development scientists and manufacturingengineers who are looking for effective and efficient virus clearance solutions.Inese Lowenstein, Group Product Manager, Virus Clearance, Bioprocess R&D,Millipore CorporationMani Krishnan, Program Manager - Virus Clearance, Bioprocess R&D,Millipore CorporationSal Giglia, R&D Manager, Bioprocess R&D, Millipore Corporation12:15 Luncheon and Technology WorkshopSponsored by:Integration, Implementation and Validation of Single-use Bioprocessing TechnologiesSingle use disposable technology is a proven alternative solution for the biopharmaceutical industry (upstream, downstream, formulation and filling) offeringseveral significant advantages over standard reusable stainless steel systems. Key factors for successful single use system integration are: Process Knowledge,Experience with Single Use Systems, Single Use Product Portfolio offering, Strong Technical Capability, Full Documentation Package, Validation SupportMonica Cardona, Marketing Manager, Pall Life SciencesCell Culture & Upstream ProcessingRecovery & Purification3 41:30 Chairperson’s RemarksSuzanne Kuo, Ph.D., Senior Engineer, Late Stage Cell Culture ProcessDevelopment, Genentech, Inc.Commercial Process Readiness, Troubleshootingand Improvements1:45 BioProcessing Challenges for Large ScaleDisposable BioreactorsDisposable bioreactors have been shown to be effective in performing batch,fed-batch and continuous cell culture processes. At large scale, the traditionaland expected challenges arise such as oxygen transfer, CO2 removal andadequate mixing time for addition of nutrients and pH control fluids. Large scaleperfusion operation presents the most extreme challenges including volumecontrol, steady feed addition, harvest removal, cell recycle and maintenance ofsterile operations in a more complex large scale system. The presentation willhighlight these challenges at large scale and will present data from a case study.Jin Yin, Senior Bioengineer, Shire Human Genetic Therapies, Inc.Geoffrey Hodge, Vice President, Process Development and Technology,Xcellerex Inc.1:30 Chairperson’s RemarksChris Dowd, Ph.D., Senior Engineer, Late Stage Purification, Genentech, Inc.Novel Process Development Strategies1:45 Process Development Strategy for High-Concentration UF/DF of MAbsProducing antibody products formulated at high concentrations is useful todeliver adequate product in small injection volumes. However, at large scalethis may be a challenge. In this presentation we will describe a well-definedexperimental approach to optimizing and scaling up the ultrafiltration/diafiltration step for the concentration and formulation step used inmanufacturing processes to produce antibody products. We have developeda robust, scalable UF/DF step that allowed us to produce clinical supplies atproduct concentrations up to approximately 125 g/L of protein. We will alsoshare observations made during the development of the diafiltration step.The experimental results for diafiltration will be presented along with theexpected theoretical trends and values for pH, conductivity, osmolarity, andconcentrations of components in the diafiltration buffer.Robert G. Luo, Ph.D., Senior Scientist, Purification Sciences, Human GenomeSciences, Inc.18 Visit www.IBCLifeSciences.com/BPI/US for up-to-date information on this event

Main Conference • Thursday, October 4, 2007 (continued)Cell Culture & Upstream ProcessingRecovery & Purification3 42:15 Comparisons of Product Quality from Disposable andStainless ReactorsAbstract unavailable at press time. Please visit IBCLifeScience.com/BPI/USfor updates.Sadettin Ozturk, Ph.D., Head, Bioprocess Technology, Centocor, Inc.2:45 Efficient Cell Culture Characterization and ValidationStudies Using a Scale-down Model for Changes to aLicensed Antibody ProcessFor a previously licensed antibody process, several process changeswere implemented. These changes required the completion of newcharacterization and validation studies. As part of the characterizationexercise, a scale-comparability assessment was performed on small-scale andpilot-scale models. Results from this study will be presented. In addition,several strategies developed to reduce the number of test cases and toincrease the efficiency of the characterization/validation exercise will bediscussed. By determining an appropriate scale-down model and performingthorough characterization and validation studies, post-approval processchanges were supported in an efficient manner with confidence in keyproduct quality attributes.Marion Piquet, Engineer I, Late Stage Cell Culture, Genentech, Inc.3:15 Networking Refreshment Break3:30 A Custom Developed Integrated Bioreactor CaseControl and Data Management System for StudyProcess Development – Leveraging Information fromEarly Stage Process Development through CommercialManufacturingOur case study represents a custom developed bioreactorSCADA(Supervisory Control and Data Acquisition) system and theassociated data management architecture to achieve the following objectives:improve process consistency, reliability of information, and productivity.A new strategy was implemented whereby available commercial controlsystems were customized for both development and GMP areas.Nicole Bleckwenn, Ph.D., Scientist II, Process Cell Culture & Fermentation,MedImmuneMichael Gammons, Associate Director, Development Information Systems,MedImmune4:00 Characterization of the Operating Parameters for theWAVE Bioreactor Expansion Stages of a CommercialScale Cell Culture Production ProcessWAVE Bioreactor technology was implemented in the cell cultureexpansion stages of a commercial production process. Operating parameterswere characterized using a Design of Experiments approach. Worstcaseconditions were identified and evaluated to determine recoveryin subsequent expansion stages. Experimental results led to operatingparameter classification based on the significance to process performanceover the characterized range. Bench and full-scale data was utilized to setacceptance criteria for monitoring process performance. Characterizationdata supporting the process scale-up will be presented.Carin Gray, Associate Scientist, Cell Sciences and Technology, Amgen Inc.4:30 Data Mining with Avastin® for ProcessImprovements and OptimizationCaseStudyAvastin® (bevacizumab) was approved in 2004 as the first therapydesigned to inhibit angiogenesis. With product growth and evolution hascome the need to align manufacturing capacity and product demand,thereby creating opportunities to improve yield, reduce cost, andincrease efficiency. This talk highlights Genentech’s approaches to miningmanufacturing data and driving such opportunities while sustainingmanufacturing process governance.Eric Fallon, Ph.D., Associate Director, Manufacturing Sciences andTechnology, Genentech, Inc.5:00 Close of Conference2:15 Accelerating Process Development: Automation ofAnalytical AssaysThe development of a protein or vaccine purification process is guided by theanalysis of samples from trial purification processes, which define processperformance. A variety of quantitative assays are used to monitor the clearanceof contaminants and excipients, and to determine the recovery and quality of thetarget biomolecule. A strategy is presented which enables complete automationa variety of process monitoring assays, from sample preparation through to datareduction and data reporting. This strategy uses commercially available robotichardware and software, augmented by a custom user interface developed usingMicrosoft Excel with Visual Basic for Applications. The interface adds the abilityto dynamically program the robotic systems, and is also structured to collect andmanage raw data, calculations, and the reporting of results. This approach has beenused to automate a variety of assay formats, such as colorimetric, dye-binding,specific protease and nuclease activity assays, fluorescence polarization assays,antigen-binding, and ELISAs. The design and function of these automated systemsis discussed here, along with the routine operation in an automated assay lab.Peter DePhillips, Ph.D., Director, Bioprocess and Bioanalytical Research,Merck and Co.2:45 Exploring “Hot Spots” In Recombinant MonoclonalAntibody MoleculesPost-translational modifications during synthesis and additional chemicalmodifications during production and storage add to molecular heterogeneityof recombinant monoclonal antibodies. This presentation will focus on howglycosylation, cysteinylation, and methionine and tryptophan oxidation mayor may not affect structure, in vitro activity, stability, and/or in vivo behaviorof monoclonal antibodies.Yuefeng Lu, Ph.D., Principal Scientist, Global Process Engineering, Amgen Inc.3:15 Networking Refreshment Break3:30 Humira After Launch – Opportunities and Challenges inDownstream ProcessHumira (Adalimumab) was successfully launched in 2002 and is currentlymanufactured at both 3,000L and 6,000L scales. During the past years ofmanufacturing, there has been a continuous effort to: (1) increase processrobustness and ensure high quality, (2) satisfy and harmonize divergent globalregulatory demands, and (3) ensure that an identical process could be launchedat the 12,000L scale. First generation process improvements were developed in2003 and implemented in 2004 to improve process robustness and harmonizethe processes at different scales. Process mapping studies were undertaken laterto refine our knowledge of process attributes like intermediate purity, yield andthe dynamic performance of each unit operation. As a result, a fine-tuned revisedadalimumab downstream process is currently approved for both 6000L and12000L scales. Data from at scale validation demonstrating improved productquality, HCP clearance, and yield will be presented.Diane D. Dong, Ph.D., Senior Scientist, Technical Operations,Abbott Bioresearch Center4:00 Use of Complex Analytical Methods to Support ProcessDevelopmentOver the past few years, significant advances have been made in complexanalytical technologies, including capillary electrophoresis and massspectrometry. These techniques routinely allow for a rigorous evaluationof the biochemical characteristics of therapeutic proteins and have provenindispensable to successful development of robust manufacturing processes.In this presentation, we will discuss potential applications of selected analyticaltools, and how and where they may be best used to support process development.Daotian Fu, Senior Director of Analytical Development, Genzyme Corporation4:30 Evaluation of Conformation and Bioactivity of aMonoclonal Antibody Product as a Function of Timeand pH Following Protein A ChromatographyEvaluation of process design space throughout development and commercialmanufacturing of a monoclonal antibody product provides improved understandingof the effects of processing conditions on conformation and bioactivity of theproduct. Such increased understanding has the potential to be used for bothnonconformance investigations and justification of process improvements.Paul Baptiste, M.S., Senior Process Scientist, Purification Technology,Centocor (GBSC)5:00 Close of Conference19 To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com

Two-Day Courses • Monday, October 1, 2007 to Tuesday, October 2, 2007Maximize your learning experience at BPI … combine one of the following training courses with thescientific conferencce sessions on Wednesday & Thursday at a special 4-day rate. See page 25 for details.Technology Transfer ofBiopharmaceuticals 101:Ensuring Successful Transfer andImplementation of ProcessesYou will Learn:• The fundamentals inherent of all types of technologytransfer• The tools required to create and implement atechnology transfer• About the key players on technology transfer teams– who, what, when• How to avoid the common pitfalls inherent in alltransfersBenefits of Attending:• Learn the different types of technology transfer andhow to design and implement programs specific toeach type of transfer• Understand the technical and regulatoryrequirements for successful transfer• Explore the different types of team structures usedin various types of technology transfer programs• See why tech transfers “go wrong” and learn how toavoid the common mistakes• Receive a comprehensive course book that serves asa future referenceWho Should Attend:Scientific, regulatory, and quality personnel involved indesigning, conducting, participating, or reviewing thetransfer of production processes (both upstream anddownstream), analytical methodology, and entire drugprograms. This includes managers, supervisors and staffmembers from R&D, production, engineering, QC,quality assurance and regulatory affairs groups.Course Description:Transfer of developed processes or procedures betweengroups and/or sites has been, historically one of theweak links in the biopharmaceutical chain. This coursedetails the technical, regulatory, and philosophical issuessurrounding the process of technical transfer. Definitionsand examples of the different types of transfers, includingdiscussions on the levels of complexity inherent in eachtype of transfer will be discussed. Topics will includeproject management, team structure, implications ofengineering, scale-up, and comparability programs. Byattending you will learn what makes for a successful andunsuccessful transfer as well as participate in exercisesto help delineate the skills required to participate in atransfer process.Introduction toBiopharmaceuticalManufacturingYou will Learn:• Fundamental processes and operations in themanufactureof biopharmaceuticals• Primary issues faced by manufacturing anddevelopment personnel and how to overcome them• Regulatory aspects of manufacturing and the role ofmanufacturing in meeting quality standardsBenefits of Attending:• Gain an overall perspective on the manufacture ofbiopharmaceuticals and the component steps usedin production• Gain an understanding of the technology employedin manufacturing, even if you have a non-technicalbackground• Identify the major methods for testing and wherethey are used• Understand the concepts underlying processvalidation• Receive a comprehensive course book that serves asa future referenceWho Should Attend:• Individuals who need a working knowledge ofbasic biotechnology design principles, or whoare responsible for process design, facility design,equipment/system design/selection or operation of abiopharmaceutical production facility• Those who are involved in biopharmaceuticalproject engineering and management or QA/QC,facility design, or facility construction• Individuals beginning work in productionoperations, quality assurance, regulatory complianceor other areas in a biopharmaceutical facility orbiopharmaceutical development companyCourse Description:This course introduces the fundamental processes andoperations in the manufacture of biopharmaceuticals.Beginning with expression systems and moving throughfermentation, cell culture, recovery, purification,formulation and filling, we will discuss the process stepsinvolved in producing biological products. We willalso introduce the basic concepts of process design andanalytical methods for characterization of biologicalproducts. The course will conclude with a description ofthe role of quality and the regulatory environment underwhich biologicals are produced, including validation.Though the manufacture of biopharmaceuticals iscomplicated and difficult, this course will provideperspective around the many operations that make upa manufacturing process and help you understand howthey work together to provide safe and effective products.Design of Experimentsin BiopharmaceuticalDrug DevelopmentYou will Learn:• How to apply Design of Experiments to developcritical parameters for biopharmaceuticalmanufacturing and analytical development• How DOE leads to efficient drug development bysaving cost and resources• How to demonstrate that you understand yourprocess by generating imperical models from yourdata• How to identify critical process attributes andinteractions for robust product specificationsBenefits of Attending:• Gain understanding of the criteria for establishingprocess control parameters• Interact with fellow process development andprocess validation professionals who are trying toaddress similar issues• Gain understanding of how your process meetscritical quality attributes• Optimize strategies to reproducibly align yourprocess control parameters with meeting finalproduct specifications• Use hands-on training in protocol design tosuccessfully support drug development activitessuch as: Assay Qualification, Pre-Validation,Manufacturing Process• Receive a comprehensive course book that serves asa future referenceWho Should Attend:This course is tailored to process development scientists,engineers, and managers. Biopharmaceutical processesare studied to determine the process control parametersand ranges of acceptable operation.• Engineers, managers from product development,manufacturing, research and quality control• Project directors in process development tooutsourcing• Professionals from Pre-IND, Phase 1, 2, 3 throughclinical trialsCourse Description:In this course, you will learn about Design ofExperiments and how to use designed experimentsto perform efficient Drug Development inbiopharmaceutical manufacturing processes. You willexamine and have an understaning of formulation andanalytical development and how it relates to DOE.Designed experiments are a powerful tool to improveproducts, processes and practices to determine the cuaseand effect relationship between controlled variables andoutputcharacteristics. You will also learn to improveprocess output characteristics including quality, cost, androbustness through generating empirical models of yourprocesses in the fewest experiments possible.20 Visit www.IBCLifeSciences.com/BPI/US for up-to-date information on this event

Two-Day Courses • Monday, October 1, 2007 to Tuesday, October 2, 2007 (continued)Technology Transfer ofBiopharmaceuticals 101:Ensuring Successful Transfer andImplementation of ProcessesThe Curriculum Includes:Introduction to Technology Transfer• What is Technology Transfer?• Types of transfers and levels of complexity• What are the elements of technology transfer– who, what, when, where• Tools of the trade• Terminology – wading through the alphabetsoup• Technology transfer teams – composition andevolution• Protocols and reports• Project management tools “can’t everyone justget along?”Starting from the Beginning –It’s My Process – Just Do It!• Development with transfer as a goal• Engineering and scale• Quality and regulatory perspectives• Repeat transfers• Development and transfer as a continuum• Building in comparabilityWhen Good Processes Go Bad• Pitfalls of a poorly planned transferThe NIH syndrome – We Can ImproveYou!• Special cases – transfers to contract organizations• Legal and business implications• Negotiating site specific process changes(regulatory implications)Course Instructor:Barry Rosenblatt, Ph.D., Director of Technical Services,Charles River Laboratories and President, SME BiotechConsultantsBarry is a subject matter expert on the chemistryand manufacturing control (CMC) of biotheraputicswith a proven 20+ year track record in biotechnologyand the pharmaceutical industry. He has developed,transferred, and validated purification processes formultiple new molecular entities through all stages of drugdevelopment, including licensure by the application of aninnovative and comprehensive approach.Dr. Rosenblatt has been on the scientific advisorycommittee for numerous IBC conferences, including“BioProcess International,” and “Post TranslationalModifications.” He has presented and given workshopson Techology Transfer, Virus Validations and ProteinCharacterization and eveloped numerous internaltraining courses.Introduction toBiopharmaceuticalManufacturingThe Curriculum Includes:Expression Systems• Alternative Expression Systems: Microbial,Mammalian, Other, Including Transgenic • PostTranslational Modification • Cell BankingFermentation and Cell Culture• Fermentation: Key Process Parameters • CellCulture: Key Process Parameters • Other SystemsRecovery• Overview of Unit Operations Purification •Overview of Unit Operations • Chromatography:Principles of Chromatography, Methods andTechniquesProcess Development• Process Design and Optimization • UpstreamProcessing: Fermentation, Cell Culture, OtherSources • Downstream processing: Recovery,Purification • Formulation and Filling• Process CharacterizationScale-Up• Large Scale Constraints • Transferring Processes toManufacturing : Technology Transfer, OvercomingOrganizational BarriersAnalytical Methods• In Process • Release • Other CharacterizationRegulatory Aspects of Manufacturing• The Role of Quality in Manufacturing • CurrentGood Manufacturing Practice • InvestigationalDrugs and License ApplicationsValidation• Equipment Qualification and Facility Validation •Analytical Method Validation • Process, Cleaningand Viral Clearance ValidationCourse InstructorScott M. Wheelwright, Ph.D., President and CEO,Strategic Manufacturing Worldwide, Inc.Scott M. Wheelwright, Ph.D., has over 20 yearsexperience in biopharmaceutical manufacturing,both with startup biotech firms and with large biotechand pharmaceutical companies, including AbbottLaboratories, Chiron and Scios. Dr. Wheelwright has ledthe design and implementation of many manufacturingprocesses for biopharmaceuticals, including licensedproducts. Dr. Wheelwright holds a Ph.D. degree inchemical engineering from the University of Californiaat Berkeley. He is the author of a book on proteinpurification and has authored numerous articleson manufacturing and process development. Dr.Wheelwright currently works with several large and smallbiotech and pharmaceutical firms, where he preparesstrategic plans for manufacturing and development,audits the compliance of manufacturing operations(particularly in Japan; he reads and speaks Japanese), andassists with contract manufacturing.Design of Experimentsin BiopharmaceuticalDrug DevelopmentThe Curriculum Includes:• Examination of biopharmaceutical manufacturingprocess unit operations – fermentation, lysis/extraction, clarification/TFF, chromatography,refolding, UF/DF – with the objective ofdetermining critical process control parameters andinteractions.• Development of cost effective pre-validationstrategies to mitigate risk and maximize value forvarious activitiesParticipants will plan, execute, and analyze variousdesigned experiments. In addition they will developa designed experiment plan to run at the workplace.Specific attention will be focused on:• Basic understanding of experimental design• Ability to identify key process and product variables• Understanding of sequential experimentation• Determining the most economical design that willmeet objectives• Planning and conducting an experiment• Understanding random response variation andexperimental error• Determining main effects and range of significance• Determining what interactions are and why they areimportant• Testing underlying assumptions• Improved analysis and presentation of results• Addressing extremely complex problems in anefficient manner• Using DOE without being a highly skilledstatistician• Generating empirical models of your processes inthe fewest experimental trials possibleCourse Instructor:Dr. Rajiv Nayar, President and Founder, HTDBiosystems, Inc.Dr. Nayar received his Ph.D. in Biochemistry fromUniversity of British Columbia, B.C. After a MedicalResearch Council postdoctoral fellowship at M.DAnderson Tumor Institute, Houston, TX, he joined theCanadian Liposome Company in Vancouver, B.C. Hewas head of the Formulation and Drug Delivery Unitat Bayer Corp. Biotechnology Division in Berkeley, CAfrom 1991 until 2000. At Bayer, he was the recipient of 3consecutive awards in process continuous improvementsat Bayer Corporation. He has published over 60 scientificarticles in various disciplines including liposomes, cancerbiology, drug delivery systems, protein formulationand biochemical characterization of pharmaceuticals.He is an inventor on 8 U.S patents. Dr. Nayar is anadjunct Professor of Pharmaceutics at the Universityof Colorado School of Pharmacy. His research interestsinclude protein formulation, drug delivery systems, andpharmaceutical drug characterization. He is an expert inmultivariate statistical methodology in pharmaceuticalproduct development and a course instructor inexperimental design.21 To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com

The Largest Display of New Products & Technologies from Over 130 Exhibiting CompaniesSold Out Exhibit Hall!Professor/Academic1%Research Scientist6%Engineer13%Management(Project, Business)24%Profile of AttendeesJob FunctionsConsultant/Analyst1%Senior Scientist28%Executive Level (VP, Director,President, CEO, Principal)27%As of September 7, 2007Charles River LaboratoriesAAAS/ScienceCharter Medical, Ltd.Advanced Instruments, Inc*Cinvention AGAdvantaPure/ New Age Industries* Clonex Development, Inc.*ALFA LAVAL INCCobra Biomanufacturing PlcAlfa Wasserman Separation Technologies Colder Products CompanyAlthea Technologies, Inc.Consolidated Polymer TechnologiesAnaliza, Inc.Cook Pharmica LLCApplied BiosystemsCorning IncorporatedApplikon Biotechnology*Covance Inc.Appropriate Technical Resources, Inc. CUNO, Inc. a 3M Company*AppTecCytovance BiologicsAsahi Kasei MedicalDASGIP BioTools, LLCATMI Life SciencesDCI, Inc.AveciaDiosynth BiotechnologyAvid BioservicesDoe & Ingalls of Maryland, LLCBaxter BioscienceDow Corning CorporationBD Biosciences- Advanced Bioprocessing DowpharmaBellco BiotechnologyDSM BiologicsBIA SeparationsEden Biodesign LtdBioDtech, Inc.EMD Chemicals Inc.Bioengineering Inc.FinesseBiogen Idec IncFormatech, Inc.Biomedical Resources International, Inc ForteBio*BIOMEVA GmbHGE HealthcareBioPro International, Inc.*GenetixBioProcessorsGoodwin Biotechnology Inc.Bio-Rad Laboratories*Gore*Broadley JamesGroton Biosystems*Catalent Pharma SolutionsICOSCeleros Separations*Innovatis Inc.Cellexus Biosystems*InVitriaNow in its fifth year, the BioProcess International Conference & Exhibition exhibit hall onceagain offers the most comprehensive display of bioprocess technology in the world, includingboth upstream and downstream technologies. As an attendee, you’ll be able to evaluate theindustry’s most promising new technologies, the latest innovations to existing technologies andnever before seen product launches from some of the industry’s most inventive companies. Over25 new products will be launched at this year’s event.“BioProcess International has become a fixture on our calendar. It’s a well attended event thatdelivers us consistent opportunities for targeted networking and the chance to attend a widerange of interesting and relevant presentations from industry experts and opinion leaders.”-- Roger Lias. Ph.D., Vice President, Sales & Business Development, Cytovance“This conference renewed my faith in the combination exhibit / conference as avaluable use of time for both vendors and industry people.”-- Paul Priebe, Head of Product Management - Process Filtration & Disposable Technology, Sartorius Biotech Inc.The Most Extensive Biopharmaceutical Marketplace –Over 130 Vendors!InvitrogenIrvine ScientificKBI BioPharma, Inc.Kerry BioScienceLancaster Laboratories, Inc.*Laureate Pharma, Inc.LevTech, Inc.LonzaMallinckrodt BakerMediatech, Inc.Meso Scale DiscoveryMicroCal, LLCMillipore CorporationNalge Nunc International**NCSRT*New Brunswick Scientific Co.*Nova Biomedical*Novasep Inc.Novexin Ltd.Novozymes Delta Ltd.*Nysa Membrane Technologies*optek-Danulat, Inc.Pall Life SciencesPendotechPneumatic ScaleAngelus*Exhibit Hall HoursMonday, October 1Tuesday, October 2Wednesday, October 35:30 pm - 7:00 pm9:45 am - 7:00 pm9:45 am - 4:00 pmPolestar Technologies, Inc.ProMetic BioSciences Ltd.QSV Biologics, Inc.Rentschler Inc.RepliGen CorporationResearch OrganicsRohm and Haas Advanced BiosciencesSachem, Inc.*SAFC BiosciencesSANDOZ GmbHSartorius Stedim BiotechSciLog, Inc.*Spectrum Laboratories, Inc.TechniKromThe IMPACT Marketing GroupThermo ScientificTosoh Bioscience, LLCWave Biotech, LLCWestfalia Separator, Inc*Xcellerex, Inc.* The companies planning on launchingNew Products at BioProcessInternational Conference & Exhibitionare indicated with an asterisk *Drive Your Global Sales & MarketingThe best marketing vehicle to reach the Bioprocessing market is BioProcess International Conference & Exhibition – the largest and most recognizedindustry event of the year! Exhibiting and sponsorships include:• Exhibit Booths (Sold out!) • Tote Bags (Sold out!) • Receptions (Sold out!) • Focus Groups• Technology Workshops (Sold out!) • Laynards/Badges (Sold out!) • Hospitality Suites (Space is limited) • Site Tours (Sold out!)• Session Sponsorships • Portfolios • Luncheons (Only 1 remaining)Additional avenues to raise awareness of your company's products or services can be tailored to meet your marketing needs. To learn more aboutsponsoring or exhibiting at BPI or other events within IBC's Biopharmaceutical Production Series, please contact Mike Washkowitz, Ph.D., SeniorBusiness Development Manager at (508) 614-1439 or mwashkowitz@ibcusa.com22 Visit www.IBCLifeSciences.com/BPI/US for up-to-date information on this event

Event SponsorsExecutive Sponsor:SAFC Biosciences is the world’s leading supplier of critical raw materials and specializedcell culture reagents to producers of marketed biological products. Fully dedicated to theneeds of customers at every stage of the clinical pipeline, SAFC Biosciences has the expertise,manufacturing capabilities, quality systems and technical support necessary to acceleratecustomer success. SAFC Biosciences is not just a supplier, but an extension of our customers’capabilities. A global organization with multiple cGMP facilities for cell culture applicationsin the United States, Europe and Australia, we supply the broadest range of highly customizedservices and products to companies involved in cell culture-based manufacturing. We haveunique offers for those involved with industrial-scale biopharmaceutical research; processdevelopment, materials management; quality assurance; and manufacturing. We focus ontailored solutions and manufacturing processes designed to meet the specific needs of ourcustomers. Visit www.safcbiosciences.com to view our unique Cell Culture Capabilities Cube.Corporate Sponsors:Sartorius is an international leader in process technology in biotechnology. Sartoriusspecializes in the manufacture and support of separation and purification equipmentscaleable from R&D to production levels. This includes process, pilot and laboratoryfiltration systems for pharmaceuticals and biotech industries, and a portfolio which includesmembrane and depth filter cartridges, capsules, fermentors, bioreactors (both reusable anddisposable), crossflow micro and ultrafiltration systems, life science laboratory devices,cell culture products, sanitary housings and filter integrity test equipment, single use fluidhandling and mixing technology.Session Sponsor:Associate Sponsor:Scientific excellence that achieves new standards of care drives the company's work. Over 20products are currently in clinical development addressing a variety of key medical needs. Inaddition to Biogen Idec's promising portfolio of drug candidates, the company's capabilitiesand capacity for protein manufacturing are world-class in quality and scale. The company isone of a handful of biotechnology companies that has three licensed and dedicated biologicalbulk-manufacturing facilities, including its large-scale manufacturing plant in Research TrianglePark, NC, which is one of the world's largest cell culture facilities. An additional large-scalemanufacturing plant is under construction in Hillerød, Denmark. Biogen Idec has sufficientcommercial manufacturing capacity for its own pipeline, as well as potential partners' products.GE Healthcare Bio-Sciences provides a broad range of products and services for proteinseparation, medical diagnostics and drug discovery. For bioprocess protein separation a widerange of products and services for chromatography and membrane separations, from lab toproduction scales are offered. Our products are used in the manufacture of the majority of allFDA-approved biopharmaceuticals on the market. Chief products include: • Chromatographysystems and media • Filtration systems and devices • Disposable bioreactors and mixers • Cellseparation for isolating and purifying cells, viruses, and sub-cellular particles • Fast TrakBioPharma Services. GE Healthcare Biosciences is a part of GE Healthcare, a General Electriccompany with more than 42,000 employees, providing transformational medical technologiesthat are shaping a new age of patient care.Invitrogen Corporation develops technologies for life science research, drug development,and commercial bioproduction. We strive to accelerate biological understanding throughtechnologies and services that include leading industry names such as GIBCO, MolecularProbes, Dynal, Quantum Dot, Zymed, and BioSource. Our product and service portfoliospans the breadth of drug discovery and development applications, as well as emerging areassuch as diagnostics, nanotechnology, and regenerative medicine.Bio-Rad has the chromatography products that allow you to achieve results. Visit ourbooth to learn more about our innovative process chromatography columns, CHT ceramichydroxyapatite and CFT ceramic fluoroapatite, UNOsphere and Macro-Prep IEX media,Macro-Prep HIC supports, and Chelex and AG resins.Technology Workshop Sponsors:Applied BiosystemsAmProteinBD Biosciences – Advanced BioprocessingDiosynth BiotechnologyForteBioGE HealthcareInvitrogenIrvine ScientificMillipore CorporationNovasep Inc.SAFC BiosciencesSartorius Stedim BiotechThermo ScientificBiopharmaceutical Production Series Sponsor:With over three decades of lifescience innovation, Irvine Scientific provides superior industrial cellculture media products and custom media manufacturing for the biopharmaceutical industry. Ourongoing personal service, technical support, and accessibility to our key team members ensures thatyour questions and concerns are addressed every step of the way. Our world-class cGMP facility wasthe first media manufacturing facility in the United States to receive ISO 13485:2003 certification.At Irvine Scientific our staff is virtually an extension of yours. Our objective is to become thesupplier of choice for custom media formulations, optimization, and contract manufacturing.Novasep Process specializes in solving purification solutions for the Pharmaceutical,Biopharmaceutical and Industrial Biotech markets. The company offers a full range ofservices including process development, multi-ton scale custom purification and performanceoptimization to solve your separation challenges. Novasep Process provides bio-purificationprocesses (studies, process design development, equipment, systems) from lab to industrialscale. Novasep Process provides innovative solutions (preparative LPLC,MPLC, HPLC systems,membranes and more…) to purify your vaccines, therapeutic proteins, mAbs…SAFC Biosciences develops, manufactures and markets cell culture reagents, specialtychemicals, bioproducts and biodisposables to organizations involved in developing andmanufacturing biopharmaceuticals. An industry leader providing reliable products andcustomized services for more than 30 years, SAFC Biosciences has GMP, ISO certifiedmanufacturing and distribution facilities in the United States, Europe and Australia.Reception Sponsors: SAFC Biosciences, Biogen IdecLuncheon & Technology Workshop Sponsor:Pall Life SciencesTote Bag Sponsor: Sartorius Stedim BiotechBadge and Lanyard Sponsor: SAFC BiosciencesSite Tour Sponsors: Applied Biosystems, Biogen Idec Inc.,DSM Biologics, GE HealthcareSupporting Organization: Pfizer Inc.23 To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com

Visiting Boston and New EnglandBoston boasts a wealth of historic landmarks in a dynamiccultural setting. The Freedom Trail, Old North Church, PaulRevere’s House, and Faneuil Hall Marketplace are just a fewexamples of this city’s rich and varied history. For informationon sightseeing activities and organized tours of Boston andthe New England area, please contact the Boston Conventionand Visitors Bureau at 1-888-SEE-BOSTON.Venue: Hotels: Hotel, Venue and Travel InformationJohn B. Hynes Veterans MemorialConvention Center900 Boylston Street,Boston, MA, 02115Phone: 617-954-2000Fax: 617-954-2299www.mccahome.comBack Bay Hilton40 Dalton Street,Boston, MA, 02115-3123Tel: 1-617-236-1100Fax: 1-617-867-6104The Boston Park Plaza50 Park Plaza at Arlington Street,Boston, MA 02116Tel.: 1-617-426-2000The Colonnade Hotel120 Huntington Avenue,Boston, MA 02116Tel: 1-617-424-7000Reservations: (800) 962-3030Reservations Fax (617) 425-3222DISCOUNTED HOTEL RESERVATIONS: Please call the hoteldirectly before September 7, 2007, to be included in IBC’s dedicatedroom block for this conference. Please be certain to mention IBCalong with the conference title and date of the conference.For additional assistance in finding a hotel room for theBPI conference, please call 1-800-516-4265 or1-203-431-8950 or visit this website:https://www.etouches.com/reg/newreg.php?eventid=1281AIR TRAVEL RESERVATIONS: For all air travel arrangements,including International, please call or write IBC’s official air travelagency, Commonwealth Travel Advisors, to book your travelvia IBC’s airline of choice, American Airlines. E-mail: jdwyer@traveladvisors.com or call: USA: 888-703-4286 or 508-366-3660;International: 508-366-3660. Please be certain to mention IBC alongwith the conference title, date and conference code B3171 whene-mailing or calling. Please note that there is a $29.00 booking feefor using this service.Additional Registration InformationUnauthorized solicitation is strictly prohibited at this eventand failure to comply could result in revokation of your accessprivileges. This is a trade only event. For your safety and security,a photo identification and industry related business card arerequired at the conference check-in to complete your registration.Program content and speakers subject to change. Children under18 are not permitted in the exhibit hall under any circumstances.Conference badges are non-transferable and lost badges will not bereplaced without payment of the full conference registration fee.Other Information: Conference registration fee includes luncheons,exhibit hall, receptions, technology workshops, refreshments, andCD-ROM with speaker documentation. Please note that payment isrequired in advance of the conference. Please make check(s) (in U.S.funds drawn on a U.S. bank) payable to IBC USA Conferences andattach to the registration form. Confirmation of your booking will besent. Should you elect to pay by MasterCard, Visa or American Express,please send your credit card number, expiration date, name as itappears on card and signature along with the registration form.Substitutions/Cancellations: Should you be unable to attend for anyreason, please inform IBC in writing prior to September 14, 2007 and acredit voucher for the full amount will be issued which must be usedwithin one year of issuance. If you prefer, a full refund less a $395 nonrefundabledeposit will be issued. No refunds or credits will be givenfor cancellations received on or after September 14, 2007.Substitutions of enrolled delegates may be made at any time. Pleaseindicate upon registration whether you are eligible for a discount.No two discounts can be combined. If, for any reason, IBC decidesto cancel this conference, IBC does not accept responsibility forcovering airfare, hotel, or other costs incurred by registrants includingdelegates, speakers, sponsors, and guests. Program content subject tochange without notice. The press may not quote speakers or delegatesunless they have obtained their approval in writing.SPECIAL NEEDS: If you have a disability or special dietary needs,please let us know in order that we may address your specialneeds for your attendance at this show. Please sendyour special needs via email to custserv@ibcusa.com orfax 508-616-5522.24 To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com

BioProcess International Conference & Exhibition Registration Form5 Easy Waysto Register!1. Phone: (800) 390-40782. Fax: (941) 365-01043. Email: reg@ibcusa.com4. Online: www.IBCLifeSciences.com/BPI/US5. Mail: IBC USA Conferences,P.O. Box 414525, Boston, MA 02241-4525Step One: Please complete the followingNAMEJOB TITLEE-MAIL q Yes, I would like to receive occasional e-mail messages and offers from other organizations.ORGANIZATIONDEPARTMENTMAILING ADDRESSCITYSTATE POSTAL CODE COUNTRYB3171PDFStep Eight: Payment informationPayment is required in advance of the conference.r Mastercardr Visar American Expressr Checkr Wire Transfer Total: $_____________Please make check(s) (in U.S. funds drawn on a U.S.bank) payable to IBC USA Conferences and attach tothe registration form. Confirmation of your bookingwill be sent. Payment by bank transfer: If you wouldlike to remit via ACH or wire transfer please emailaccount-liaison@informausa.com for details.TELEPHONE FAX APPROVING MANAGERData Protection: The personal information shown on this form, and/or provided by you, will be held on a database and may be shared with companies in the Informa group in the UK and internationally. Sometimesyour details may be obtained from, or made available to, external companies for marketing purposes. If you do not wish for your details to be used for this purpose, please email data-admin@ibcusa.com.Step Two: Please select your conference packageOn or before On or before On or before On or before AfterIndustry Fees June 8, 2007 July 13, 2007 August 3, 2007 August 31, 2007 August 31, 2007Dual Conference Pass (Mon.-Thur.) – NEW! o $2099 o $2199 o $2299 o $2399 o $24994-Day Main Conference plus Co-located Formulation Conference & Materials4-Day Conference Pass & Pre-Conference Workshop (Sun.-Thur.) t o $2099 o $2199 o $2299 o $2399 o $24994-Day Conference Pass (Mon.-Thur.) o $1699 o $1799 o $1899 o $1999 o $20993-Day Conference Pass & Pre-Conference Workshop (Sun.-Wed.) t o $1899 o $1999 o $2099 o $2199 o $22993-Day Conference Pass (Choose one: o Mon.-Wed. o Tues.-Thurs.) o $1499 o $1599 o $1699 o $1799 o $1899Training Course (Mon. - Tues. ) & 2-Day Main Conference Pass (Wed.-Thur.) n o $2399 o $2399 o $2399 o $2399 o $2399Training Course Only (Mon. - Tues. ) n o $1599 o $1599 o $1599 o $1599 o $1599On or before On or before On or before On or before AfterAcademic/Government* Fees June 8, 2007 July 13, 2007 August 3, 2007 August 31, 2007 August 31, 2007Dual Conference Pass (Mon.-Thur.) – NEW! o $1099 o $1199 o $1299 o $1399 o $14994-Day Main Conference plus Co-located Formulation Conference & Materials4-Day Conference Pass & Pre-Conference Workshop (Sun.-Thur.) t o $1099 o $1199 o $1299 o $1399 o $14994-Day Conference Pass (Mon.-Thur.) o $699 o $799 o $899 o $999 o $10993-Day Conference Pass & Pre-Conference Workshop (Sun.-Wed.) t o $899 o $999 o $1099 o $1199 o $12993-Day Conference Pass (Choose o Mon.-Wed. o Tues.-Thurs.) o $499 o $599 o $699 o $799 o $899Training Course (Mon. - Tues. ) & 2-Day Main Conference Pass (Wed.-Thur.) n o $1399 o $1399 o $1399 o $1399 o $1399Training Course Only (Mon. - Tues. ) n o $899 o $899 o $899 o $899 o $899*Academic/Government rate is extended to full-time employees of government, universities, and university-affiliated hospitals only. For securityprecautions, a photo identification will be required of ALL attendees at check-in. For on-site conference registrations, please add $100.Step Three: To reserve a posterboard (space is limited)o $50 Commercial o FREE Academic/GovernmentStep Four: Please indicate if you wish to attend a Sunday Workshop (Only for packages identified with t)o A. Analytical Methodso B. Transient TransfectionStep Five: Please indicate if you wish to attend a Training Course (Mon-Tues.) (Only for packages identified with n)o 1. Intro to Biopharmaceuticals o 2. Design of Experiments o 3. Tech TransferStep Six: Please select which conference track you primarily plan to attendo Production & Economics of Biopharmaceuticalso Scaling Up from Bench through Commercializationo Cell Culture & Upstream Processingo Recovery & PurificationStep Seven: Please indicate if you wish to attend a Site Touro Biogen Idec (Tues.) o DSM Biologics (Tues.) o Applied Biosytems (Wed.)Space is limited. You must register for a site tour by August 31. You will notified by September 14 if you are confirmedto attend. You must register for the BPI Conference to be eligible to attend the site tours.Card #Exp. DateName (as appears on card)SignatureUnable to Attend? Purchase the Conference CD-ROM. The conference CD-ROM containing a selectionof speaker presentation slides from the conferencewill be available four weeks after the conference.o I cannot attend. Please send ______ MainConference CD-ROM(s). Enclosed is my paymentfor $399 each, plus shipping and handling($25 in the U.S., $45 outside the U.S.).Team Discount:Register 3,the 4th goes FREE!When three members of the samecompany register for the conferenceat the same time, the fourth attendsfor FREE! Complete registrationforms for all parties must be senttogether with complete paymentsfor the entire group to qualifyfor team discounts. No partialpayments or registrations sentwithout payment are eligible for thisdiscount. Note: The free registrationwill be applied to the lowestconference fee option.25 Visit www.IBCLifeSciences.com/BPI/US for up-to-date information on this event