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Thursday, September 23, 2010 • Main Conference 12:00 Concurrent Technology Workshops Hybrid Purification – The Next Generation of Cell Clarification Cell clarification in the biopharmaceutical industry has long been dominated by adsorptive depth filtration. Traditional cellulose-based depth filters feature natural materials that are prone to variation in performance and extractable profile. This workshop will present an overview of a fully synthetic “hybrid purifier” that is being designed to increase flexibility in cell clarification, minimize performance variation and improve overall process efficiency both upstream and downstream. Thomas P. O’Brien, Ph.D., Senior Applications Specialist, 3M Purification Inc Cell Culture Media Platform for the Rapid Production of Gram Quantities of Recombinant Antibodies from CHO Cells Transformed with the Selexis Vectors Results from a collaborative program between Irvine Scientific, CA., USA and Selexis, S.A., Geneva, Switzerland will be presented. Tom Fletcher, Director, Cell Culture R&D, Irvine Scientific Pierre-Alain Girod, Ph.D., Chief Scientific Officer, R&D, Selexis SA, Switzerland Multi-Fold Titer Improvement through Integrated Medium and Feed Design High cell densities and product yields require culture media and feeds formulated so that no one nutritional component becomes limiting. Integration of the basal medium and feed design ensures nutrient availability. IgG titers of 2.6 g/L were reached using an integrated design strategy compared with starting titers of 0.5 g/L. This represents a 10-fold improvement over batch culture. Potential challenges and solutions will be discussed. Shawn Barrett, Senior Manager, R&D, Invitrogen, part of Life Technologies POROS® XS: A High Capacity, High Resolution CEX Resin The features and performance of POROS® XS chromatography resin will be highlighted. The benefits of a high capacity, high resolution, salt tolerant CEX resin as they relate to improving downstream purification process performance and productivity will be proposed. Applications data and process productivity modeling will be used to demonstrate the benefits of utilizing POROS XS. Christine Gebski, M.S., Director, POROS Applications and R&D, Applied Biosystems, part of Life Technologies 12:30 Networking Luncheon in Exhibit and Poster Hall 1:00 Featured Presentation in Exhibit and Poster Hall The Enduring Need for Operational Excellence: Lessons Learned from the Oil Field to Biotech and How Great Companies can Still Fall Short BP’s oil disaster in the Gulf shows how decisions and events can impact global organizations. Genzyme was hit with a virus that was undetectable by the industry’s standard viral tests and led to a global shortage in supply of critical medicines. During this presentation, Mark Bamforth will reflect on the importance of relentlessly pursuing Operational Excellence and how events can still impact an organization. Mark R. Bamforth, President & CEO, Gallus Biopharmaceuticals; Former Senior Vice President, Corporate Operations and Pharmaceuticals, Genzyme Corporation Recovery & Purification 1:45 Chairperson’s Remarks Uwe Gottschalk, Ph.D., Vice President, Purification Technology, Sartorius Stedim Biotech, Germany Implementing the Latest Tools and Techniques to Optimize the Harvest Step 2:00 Optimization of the Harvest Step Cell culture harvest often involves centrifugation and filtration operations. The requirements for the filters depend on the size and amount of particles which remain suspended in the broth after centrifugation. Particle-size analysis of benchtop centrifuge clarification runs gives information which can be used for specification of the filters and for optimization without needing to gather data at the production scale. Roy Hegedus, Ph.D., Senior Scientist, Purification, Process Sciences, Abbott Bioresearch Center 2:30 Enabling Precipitation as an Operation to Manage Critical Contaminants in Bioprocessing Precipitation is a versatile technique for contaminant removal and product capture but not commonly used in the production of biologics. Reasons cited for this surround difficulty in finding the desired yield and purity. This dogma is removed if we adopt techniques to accelerate this search process, enabling evaluation of the large design spaces that result from combinations of precipitation agents. Daniel G. Bracewell, Ph.D., M.S., Department of Biochemical Engineering, University College London, United Kingdom 3:00 Exploring Expanded Bed Adsorption for Capture of Antibodies from CHO Cultures A New Protein A based expanded bed adsorption chromatography media was examined as a method of capture for monoclonal antibodies from CHO cell cultures. Purification performance of this resin was examined relative to conventional protein A chromatography. Capacity, cleaning alternatives, and stability of the resin in cleaning and storage solutions are examined. Richard S. Wright, Principal Research Scientist, Pfizer Biotherapeutics 3:30 Networking Refreshment Break in Exhibit and Poster Hall Overcoming Challenges of Production, Purification and Characterization of Next Generation Antibody-Like Molecules & Protein Therapeutics 4:00 CASE STUDY Investigation into the Concentration Limit of a PEGylated Protein This study illustrates concentration limitations for a mono PEGylated protein. The desired PEGylated protein concentration was 60mg/ml but only 24 mg/ml was achieved by UF/DF. We demonstrated that the protein could be concentrated to >60mg/ml while linear PEG could be concentrated to 25 or 35 mg/ml in formulation buffer or WPU, respectively, demonstrating that PEG was the limiting concentration factor. Sarah Holtschlag, M.S., Senior Scientist, Downstream Process Development, Diosynth Biotechnology 4:30 Assembly and Purification of Knob and Hole Bispecific Antibodies Abstract not available at press date. Please visit www.IBCLifeSciences.com/BPI for updates. Josefine Persson, Ph.D., Scientist, Early Stage Purification, Genentech, Inc. 5:00 Applications for Biopharmaceuticals in Regenerative Medicine Many biopharmaceuticals and biological products are designed to block disease pathways or replace missing factors but there is a growing interest in their application to regenerative medicine wherein biological systems are restored to their healthy state. This presentation will discuss some of the manufacturing and analytical challenges that are specific to products for regenerative medicine. Peter W. Wojciechowski, Ph.D., Director, Product and Process Development, Advanced Technologies and Regenerative Medicine, LLC (ATRM) 5:30 Immunodrugs TM – Development of a New Class of Therapeutic Vaccines Cytos Biotechnology is developing a new class of vaccines (Immunodrugs TM ) targeting several indications including major chronic diseases. By highly repetitive presentation of disease-related proteins on the surface of virus like particles (VLPs), Immunodrugs TM elicit a potent immune response against said disease-related proteins with the potential to offer therapeutic benefits. The concept, production and application of Immunodrugs TM will be presented. Frank Hennecke, Ph.D., Executive Vice President, Product Development, Cytos Biotechnology, Switzerland 6:00 Close of Day Interested in sending a team Take advantage of discounted group rates for 3 or more. For more information, contact 646-895-7445 Cell Culture & Upstream Processing 1:45 Chairperson’s Remarks Kevin J. Kayser, Ph.D., Associate Director, Cell Sciences and Development, SAFC Host Cell Engineering to Improve the Yield and Quality of Biotherapeutics 2:00 Proven Approaches to Determine Manufacturability of Candidate Molecules An early determination of the manufacturability of biological molecules is crucial for the successful development of biotherapeutics. This assessment begins with an evaluation of the drug-like properties of candidate molecules and continues with the development of cell line and downstream processing. This presentation will explore analytical approaches for the selection of the most suitable immunoglobulin molecules for development as biotherapeutics. Czeslaw Radziejewski, Ph.D., Senior Group Leader, Protein Analytics, Abbott Bioresearch Center 2:30 Profiling Highly Conserved MicroRNA Expression in Chinese Hamster Ovary Cells and Its Applications in Cell Engineering We used microRNA array and quantitative RT-PCR to profile highly conserved microRNA expression in CHO cells. miR-221, miR-222, miR-125b, miR-19a and let- 7b were differentially expressed in IgG producing lines. We also investigated miR-24 expression in CHO cell lines with different DHFR genotypes. The results represent initial effort towards understanding miRNA expression in CHO cells and towards using miRNAs in cell engineering. Nan Lin, Principal R&D Scientist, Cell Sciences and Development, Sigma-Aldrich 3:00 Use of RNAi to Transform Biotherapeutics RNAi technology can be utilized in bioprocessing to reduce levels of proteins in cellular pathways that impact biotherapeutic quality, activity, and specific productivity. 1 nM siRNA added directly to 40L of CHO cells reduced levels of a selected protein >80%. This approach is amenable to existing cell lines, and the expression of multiple proteins can be reduced simultaneously. David Kocisko, Ph.D., Principal Scientist, Alnylam Biotherapeutics 3:30 Networking Refreshment Break in Exhibit and Poster Hall Implementation of Novel Media Development and Feed Strategies 4:00 CASE STUDY Learning from High-Performance Chemically- Defined Media Formulations for CHO Platform Processes Chemically-defined media without hydrolysates were developed and compared for a platform fed-batch process and enhanced fed-batch processes. The development and implementation approach will be described. Key features will be presented including media component effects on performance and product quality. In addition, manufacturability aspects on implementing the platform process media will be described. Masaru Shiratori, Ph.D., Engineer II, Late Stage Cell Culture, Genentech, Inc. 4:30 How Media Optimization Impacts Quality Maintaining quality comparability while maximizing productivity creates constant challenges for bioprocess development. The effect of culture media on cell performance and product quality was investigated for antibodies with established quality profiles. Media composition impacted cell growth, productivity and posttranslational modifications. The results provide guidance for further correlation between media and product quality. Zhaohui Geng, M.D., M.S., Principal Scientist, Cell Process Development, Pfizer Biotherapeutics 5:00 From Hydrolysates to Unique Molecules: Identification of Bioactive Components Supplementation of cell culture media with hydrolysates has replaced serum to increase cell viability and productivity of recombinant bio-therapeutics. Although hydrolysates are a better option than animal-derived serum, they are still a biologically-based raw material with potential to add variability and risk to an already complex bioprocess. Deconstruction of hydrolysates using chromatography, peptide sequencing, and other biochemical techniques has allowed our team to utilize high resolution analysis techniques, such as LC-MS and GC-MS to identify unique components. DoE of these identified molecules has resulted in the formulation of a chemically-defined animal-free component supplement that provides the cell productivity properties of a hydrolysate in mammalian cell culture. Elizabeth Dodson, Ph.D., R&D Manager, BioAnalytical Chemistry Bionutrients R&D, BD Biosciences - Advanced Bioprocessing 5:30 Chemically-Defined Cell Culture Platform Development for Therapeutic Antibody Production We have developed a protein-free chemically-defined fed-batch process which could support cell growth at high cell density across several Abbott cell lines. The antibody titer produced from this CD process is comparable to the existing hydrolysate-based cell culture platform. To further optimize the process, we have applied genetic and metabolic analyses to identify key nutrients and possible limitations on cell growth and productivity. John Fann, Ph.D., Senior Group Leader, Cell Culture, Process Sciences, Abbott Bioresearch Center 6:00 Close of Day Strategy Discussion Forums 1:45 Development and Manufacturing Strategies for Biosimilars Products Topics for discussion: • Status of US regulatory framework • Role of contract manufacturing organizations in biosimilars • Lessons learned from Europe • Managing regulatory and market uncertainties in the Biosimilars sector Moderator: Thomas J. Vanden Boom, Ph.D., Vice President, Global Biologics R&D, Hospira, Inc. Panelists: Parrish M. Galliher, Founder and Chief Technology Officer, Xcellerex, Inc. Stanley S. S. Hong, Ph.D., Senior Vice President, Head of Research & Development, Celltrion, Inc., Korea Friedrich Nachtmann, Ph.D., Head, Biotech Cooperations, Sandoz Biopharmaceuticals, Austria Curran Simpson, Senior Vice President, Operations, Human Genome Sciences, Inc. Play an active role in this conference by showcasing your results in a poster display. Did you know that 85% of our conference attendees stated that reviewing posters is one of the most important features of our events Get your research in front of your peers and make your mark in this industry – gain the visibility you need to find exciting new opportunities in your company or your career. Justify Your Trip – presenting a poster at a scientific conference helps justify the time and cost for you to attend the conference. Not only are you attending the conference to learn new techniques and strategies, but you are also gaining for yourself and your company well-deserved recognition for innovative research findings, successful business models, unique service propositions, or creative business strategies. Share – this is your opportunity to offer your experience, expertise and insights to fellow colleagues and potential partners. Gain Recognition – all posters will be displayed for attendees, exhibitors, and presenters to see during exhibit hall hours and networking functions. The deadline to submit an abstract for inclusion in the BioProcess International Magazine September Issue Pre-Show Event Guide Insert is August 4th, 2010. (Abstract and full payment of conference and poster fees must be received by this date.) The size of the poster board is 4'x8'. Please note: Poster presentations may not be used as exhibit displays or for marketing purposes. All posters are subject to approval by conference organizers. The deadline to submit an abstract for inclusion in the conference documentation is August 20, 2010 (Abstract and full payment of conference and poster fees must be received by this date.) After that date posters are on a space available basis. To submit your poster and for additional details on the poster sizes and regulations, please visit www.IBCLifeSciences.com/BPI Visit www.IBCLifeSciences.com/BPI for up-to-date information on this event 10
Friday, September 24, 2010 • Main Conference 7:30 Coffee Recovery & Purification Cell Culture & Upstream Processing 8:00 Chairperson’s Remarks Pete Gagnon, MS., Chief Scientific Officer, Validated Biosystems Evaluation and Implementation of Next Generation Purification Technologies 8:15 CASE STUDY Strategies to Address Clarification of High Concentration Refold Pools for E. coli Based Therapeutics Abstract not available at press date. Please visit www.IBCLifeSciences.com/BPI for updates. Xuankuo Xu, Ph.D., Scientist, Process Science Downstream, Bristol-Myers Squibb 8:45 Evaluation and Implementation of New Alternatives to Standard Anion Exchange Resins and Membranes Standard industry monoclonal antibody purification processes generally include an anion exchange unit operation. Historically this has utilized a chromatography resin, but new flavors of antibody molecules in conjunction with the drive towards lower cost-of-goods and streamlined processes have led to development of alternative media forms such as membranes in flat sheet or hollow fiber configurations. This presentation will focus on evaluation of new anion exchange technologies that could improve robustness and flexibility of purification processes, presenting a comparison in terms of yield and specificity as well as robustness in a platform process. Judy Glynn, M.S., Senior Principal Scientist, BioTherapeutics R&D, Pfizer Inc 9:15 Bioengineered Protein A Polymer Beads for High-Affinity Antibody Purification Bacterial cells were engineered to cost-effectively produce polyester beads displaying the IgG binding ZZ domain of protein A at high density. The ZZ domain is part of a fusion protein which remains naturally cross-linked to the polyester core of the beads. The performance of these beads in antibody purification and their proposed use as disposable purification media will be discussed. Bernd H. A. Rehm, Ph.D., Chief Scientific Officer, PolyBatics Ltd, New Zealand 9:45 Networking Refreshment Break Process Characterization for Developing Design Space 10:15 Challenges of Technology Transfer Exacerbated by a Small Scale Model Artifact Abstract not available at press date. Please visit www.IBCLifeSciences.com/BPI for updates. Marcus P. Luscher, Scientist, Purification Process Development, Amgen Inc. 10:45 CASE STUDY Accelerated Methionine Oxidation Due to Viral Filtration A Case Study of the Limitations of Small Scale Models An accelerated stability study of protein solutions subjected to small-scale viral filtration found that viral filtered samples exhibited a higher rate of methionine oxidation compared with unfiltered controls. A series of troubleshooting studies were performed to determine if the source of the accelerant of methionine oxidation is the small-scale viral filter or the bench-scale viral filtration pressure apparatus. Tom Strickland, Ph.D., Principal Scientist, Purification Process Development, Amgen Inc. 11:15 CASE STUDY Downstream Process Characterization for a Highly Glycosylated Fc-Fusion Protein Glycosylation represents one of the most common yet complex post-translational modifications for protein biopharmaceuticals. Here we describe a case study on downstream process characterization for a highly glycosylated Fc-fusion protein. Results of this study were employed to establish a hydrophobicity specification for the HIC resin, harvest criterion for the production bioreactor and CPP acceptance criteria for the downstream chromatography steps. Canping Jiang, Ph.D., Senior Scientist, Manufacturing Sciences and Technology, Bristol-Myers Squibb 11:45 CASE STUDY Developing and Characterizing a High Concentration Ultra-Filtration Process As more products utilize high concentration formulations, the development of UFDF processes become more complicated and challenging. Process complexities combined with meeting product quality requirements, maintaining project timelines, and tailoring the process to fit into multiple manufacturing facilities create additional hurdles. This talk will discuss process development strategies used to develop, characterize, and scale up a high concentration UFDF process to full scale production. In addition, this presentation will include some of processing data collected at small, pilot, and manufacturing scale along with how they compared. Kelby Lau, Engineer II, Process Development – Late Stage Purification, Genentech, Inc. 8:00 Chairperson’s Remarks Denny Kraichely, Ph.D., Associate Director, CMC Team Lead, Portfolio Management & Technical Integration, Johnson & Johnson Pharmaceutical R&D, Inc. What Comes Next After Titer Increase 8:15 The Next Challenge(s) in Bioprocess Development Abstract not available at press date. Please visit www.IBCLifeSciences.com/BPI for updates. Martin S. Sinacore, Ph.D., Site Head, Cell Culture Development, Biogen Idec 8:45 Investigating Mammalian Cell Physiology using ‘Omics’ Tools Current strategies for bioprocess development rely on monitoring a limited set of process variables as proxies for cell physiology. Quite often, this information is insufficient and there remains a significant disconnect between these parameters and process outcomes. This presentation will provide a perspective on the use of ‘omics’ tools to query intracellular mRNA, protein and metabolite concentrations which are more likely reflective of the cell’s physiology. These tools can potentially be applied to define the molecular signature of a ‘good’ cell culture process. Karthik P. Jayapal, Ph.D., Process Development Scientist, Cell Culture Development, Bayer HealthCare 9:15 Taking a Leap Off the Platform: Reducing Timelines to Meet New Challenges The ubiquitous Platform for early-stage protein production has proven itself over the years to be very effective. However, the "one size fits all" nature lacks flexibility, and therefore is not always the right tool for the job. We have developed methods for making small to moderate amounts of protein; a scale more suited to supporting a variety of research needs, but with a flexibility, speed, and throughput that far exceeds our current platform, but remains compatible with it. Jim Mercer, Principal Engineer I, Culture Process Development, Pfizer Biotherapeutics 9:45 Networking Refreshment Break Featured Presentation 10:15 An Industrial View of Biopharmaceutical Comparability and Characterization Process and product changes (including manufacturing site, container-closure, and analytical changes) are an inevitable part of biopharmaceutical development, and have been made for every product currently on the market. Comparability studies are typically performed to assess whether the change(s) is likely to affect product safety and efficacy. Most of these have positive outcomes, but sometimes the results require additional nonclinical or clinical studies. Strategies for management of comparability study risks will be reviewed. Anthony S. Lubiniecki, Sc.D., Senior Fellow, CMC Strategy, Large Molecule Portfolio Management, Janssen Pharmaceutical Companies of Johnson & Johnson Approaches to Improve Product Quality and Achieve Process Optimization 10:45 CASE STUDY A Research Strategy to Enhance mAb Product Quality and Productivity in CHO Cell Culture Process An effective strategy was developed to support a mAb production in CHO cells. We observed a significant polymer increase with an IgG4 expressed from a CHO cell line by comparing to its NS0 counterpart. Evidence suggested that the aggregation is originated from cell culture oxidation. A new cell culture process was developed from a DOE study as well as antioxidant study. The oxidation and polymer growth were reduced significantly. The concept of QbD was also introduced to in the study. Min Zhang, Ph.D., Senior Research Scientist, BioProcess R&D, Eli Lilly and Company 11:15 CASE STUDY Maintaining Product Quality and Process Optimization from Early to Late Stage Process Development Maintaining product quality and optimization of monoclonal antibody production through all phases of clinical development creates many challenges. A case study will be presented on the efforts to maintain product quality and optimization of the cell culture process from early to late stage development. The effects of cell culture process conditions and media composition on protein production and product quality will be presented. Jason Goodrick, M.S., Senior Engineer, Late Stage Cell Culture, Genentech, Inc. 11:45 CASE STUDY QbD Approach to Cell Culture Process Characterization: A Case Study for a Monoclonal Antibody Production Process This case study presents a Quality by Design (QbD) approach used to characterize a Genentech CHO mammalian cell culture unit operation. The final outcomes of the QbD approach are both univariate and multivariate acceptable ranges for each parameter tested and a design space which ensures acceptable process performance and product quality. Szu-Han Wang, Engineer I, Late Stage Cell Culture, Pharma Technical Development, Genentech, Inc. Improving Biomanufacturing Efficiency through Recombinant Solution The current requirement for the biomanufacturing industry is to shorten the time taken to deliver new drugs to the market and reduce overall costs while maintaining regulatory compliance and product quality. During this workshop, Novozymes will discuss how the introduction of innovative technologies and products, such as recombinant protein solutions, and ongoing collaborative dialogue with the manufacturer is helping to drive efficiency improvements across the product lifecycle. Sally Grosvenor, Ph.D., Senior Scientist and Scientifict Communications Manager, Applied R&D, Novozymes Biopharma Founding Publication 12:15 Technology Workshops Simple, Innovative Technology Reduces Testing Complexity and Streamlines Bioprocessing Operations This case study details how a leading protein processing facility, Diosynth Biotechnology, implemented microvolume UV-Vis testing at critical points in the workflow to greatly reduce processing time and increase efficiency. NanoDrop microvolume UV-Vis spectrophotometers are simple tools which can be easily implemented throughout a processing organization including R&D, manufacturing and quality control with great impact on the entire workflow and on debottlenecking steps. Philippe Desjardins, Scientific Marketing Manager, Thermo Scientific NanoDrop Products 12:45 Lunch on Your Own Full Plastics - A Comprehensive Study on Using Single-Use Strategies for Generic Mab Manufacturing Using Total Disposable Technology The consistent and integrated use of disposable technologies enables a fast and reproducible GMP manufacturing and allows a substantial cost cutting for clinical supply. A comparative study on commercially available single-use technologies will be presented providing an in-depth cost comparison with conventional non-disposable facilities. Data from different stirred single-use bioreactor systems regarding operability and process kinetics at 250-L scale will be supplied as well as cell separation capacities assigned for using as disposable state-of-the-art filtration units. The integration of disposable downstream technologies will be discussed. Dethardt Müller, Ph.D., Rentschler Biotechnologie GmbH, Germany Gregor Dudziak, Ph.D., Vice President, Cell Culture, Rentschler Biotechnologie GmbH, Germany Featured Web Partner BioProcess International provides the biotechnology industry with monthly, peer-reviewed information necessary to successfully drive products through the biopharmaceutical, biovaccine and biodiagnostic development and manufacture process. BPI’s circulation consists of 30,017 mid-to-upper managers working in all phases of the biotherapeutic development and manufacturing process in the United States, Europe and Canada. Media Partners Association Sponsor For more information please visit www.bioprocessintl.com 11 To Register, Call: (800) 390-4078 • Fax: (941) 365-0104 • E-mail: reg@ibcusa.com
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