Tuesday, October 22, 2013 (continued)Well Characterized Biologicals1:30 Chairman’s RemarksZiping Wei, Ph.D., Executive Director, Novavax, Inc.Characterization <strong>and</strong> Comparability of Vaccines1:45 FDA Perspective Regulatory Considerations in the SafetyAssessment of Vaccine Adjuvants <strong>and</strong> Adjuvanted VaccinesThis presentation provides background information on vaccine adjuvants<strong>and</strong> adjuvanted preventive <strong>and</strong> therapeutic vaccines for infectious diseaseindications; present an overview of vaccine adjuvants under investigation<strong>and</strong> in U.S.-licensed vaccines; <strong>and</strong> delineates the regulatory considerationsfor the nonclinical <strong>and</strong> clinical safety evaluation of investigational vaccinescontaining novel adjuvants.Carmen M. Collazo-Custodio, Ph.D., Microbiologist, Primary Reviewer,Division of Vaccines <strong>and</strong> Related <strong>Product</strong> Applications, CBER, US FDA2:15 CASE STUDY/UNPUBLISHED DATA Analytical CharacterizationStrategies <strong>and</strong> Challenges of Protein Vaccine <strong>Product</strong>sAn enhanced approach to product development requires building productunderst<strong>and</strong>ing throughout the development lifecycle. The focus of thispresentation is on analytical characterization strategies <strong>and</strong> challengesduring protein vaccine development. Case studies are provided to elucidatethe value of characterization studies <strong>and</strong> orthogonal tools for virus-likeparticle <strong>and</strong> protein nanoparticle vaccines.Ziping Wei, Ph.D., Executive Director, Novavax, Inc.2:45 Validation of a Multiplexed Serological Method for thePotency Testing of Multicomponent VaccinesA serological potency assay on Guinea pigs is now referenced in the EuropeanPharmacopoeia for DTacP vaccine. This alternative assay will reduce thenumber of animals due to the ability to use the same animals for multipleantigens. We developed a common immunogenicity assay on guinea pigswith a multiplex antibody detection method. The current potency assay wascompared to the new potency assay. Data supporting the replacement of thecurrent potency by the new alternative assay is presented.Martine Chabaud-Riou, Scientist, Analytical R&D, Sanofi Pasteur, France3:15 Networking Refreshment Break <strong>and</strong> Exhibit/Poster ViewingWhy Do Attendees Return toWell Characterized BiologicalsYear after Year?Don’t Take Our Word for It – Read TheseRave Reviews from the 2012 Event“Well organized <strong>and</strong> balanced conference”– Parag Goyal, Principal Scientist, Dr. Reddy’s Laboratories“It’s a great conference in the biologics arena”– Shenjiang Yu, Associate Director, Merck & Co.“Even with obstacles from Mother Nature (namelyHurricane S<strong>and</strong>y), the conference went on <strong>and</strong> I had awonderful experience attending”– Wing-Yee Fu, Associate Scientist, Momenta Pharmaceuticals“…Very relevant with current events <strong>and</strong> trends. Itprovided a good arena to network <strong>and</strong> share ideas <strong>and</strong>best practices.”– John Alvino, Manager, MedImmune<strong>Product</strong> <strong>and</strong> <strong>Process</strong> <strong>Variants</strong> & <strong>Impurities</strong>Aggregation <strong>and</strong> Subvisible ParticlesFeatured Presentation10:45 Practical Considerations to Characterize <strong>and</strong>Control Protein Aggregates During theDevelopment Cycle <strong>and</strong> Commercializationwith a Focus on the Visible Size RangeThe focus will be on the value of putting in place a number of proactivesteps that anticipate the need to address aggregation within the setting ofmanufacturing <strong>and</strong> setting specifications <strong>and</strong> QbD expectations.Erwin Freund, Ph.D. Scientific Executive Director, Drug <strong>Product</strong>Engineering, Amgen Inc.11:15 UNPUBLISHED DATA Subvisible Particles <strong>and</strong> Associated Impacton Virus-Retentive Filter PerformanceTo ensure safety of antibody drug products, regulatory agencies requiresteps to ensure the removal of endogenous <strong>and</strong> adventitious viruses.The implementation of a virus-retentive filter in the purification processis intended to provide robust, size-based virus reduction orthogonal tochromatographic steps. Virus-retentive filters are vulnerable to prematurefouling by impurities, such as subvisible particle (SVP) species, present insome feed streams. This study aims to characterize the direct impact SVPshave on the virus-retentive filter performance <strong>and</strong> explore methodologies todevelop robust processes for commercial scale production.Christopher Cowan, Ph.D., Staff Engineer, Preclinical Manufacturing<strong>Process</strong> Development, Regeneron Pharmaceuticals11:45 Presentation Sponsorship OpportunityFor more information on sponsored opportunities to present an excitingtechnology or application in this conference session, please contact JenniferThebodo at jthebodo@ibcusa.com12:15 Networking Luncheon <strong>and</strong> Exhibit/Poster Viewing1:30 Chairman’s Opening RemarksWayl<strong>and</strong> Rushing, Ph.D., Senior Scientific Advisor, ABC Laboratories1:45 UNPUBLISHED DATA Underst<strong>and</strong>ing the Response of ParticleDetection Instruments to Non-Spherical ParticlesWhile most particle imaging/analysis instruments work well with sphericalparticles (e.g., polystyrene beads), actual particles (such as aggregated protein)are often irregular <strong>and</strong> elongated. We have fabricated monodisperse polymerparticles of various shapes to underst<strong>and</strong> the response of particle counters tonon-spherical particles. Detection technology considered includes: the human eye,electrical sensing zone (Coulter counter), light obscuration, <strong>and</strong> flow imaging.Michael Carrier, Bioprocess Measurements Group, National Institute ofSt<strong>and</strong>ards <strong>and</strong> Technology2:15 CASE STUDY Underst<strong>and</strong>ing <strong>and</strong> Implementing EffectiveExtractable <strong>and</strong> Leachable Programs<strong>Impurities</strong> resulting from contact surfaces in the manufacturing process or in thefinal container closure system are referred to as leachables. These compounds canhave a significant impact on the drug product’s safety <strong>and</strong> efficacy. Underst<strong>and</strong>ingthe potential sources of these compounds <strong>and</strong> the analytical tools to detectthem can be vital to a development program. Designing <strong>and</strong> implementing anextractables <strong>and</strong> leachables program can save significant time/cost in development<strong>and</strong> potentially avoid pitfalls, which may increase time to market.Wayl<strong>and</strong> Rushing, Ph.D., Senior Scientific Advisor, ABC Laboratories2:45 Analysis of Host-Cell Proteins in Biotherapeutic Proteinsby Comprehensive Online Two-Dimensional LiquidChromatography/Mass SpectrometryResidual host cell proteins (HCPs) are ppm-level contaminants inbiotherapeutics that may elicit an unpredictable immune response <strong>and</strong> needto be monitored. The identification <strong>and</strong> quantitation of low-level HCPs inbiopharmaceuticals using two-dimensional chromatography <strong>and</strong> dataindependentmass spectrometry will be discussed. The incorporation of ionmobility to resolve peptides in multiple dimensions is demonstrated.Weibin Chen, Ph.D., Senior Manager, Scientific Operations, Late StageDevelopment, PLS Business Operations, Waters Corp.3:15 Networking Refreshment Break <strong>and</strong> Exhibit/Poster Viewing8 www.IBCLifeSciences.com/WCB Variant <strong>and</strong> www.IBCLifeSciences.com/<strong>Variants</strong>Impurity Challenges in Vaccine
Tuesday, October 22, 2013 (continued)Well Characterized BiologicalsComparability Strategies for Biotechnology <strong>Product</strong>s3:45 Similarity <strong>and</strong> Comparability: What’s in <strong>and</strong> What’s out?Biosimilar <strong>and</strong> novel protein products have overlapping but distinct criteriafor successful development, licensure, <strong>and</strong> post-approval changes. This talkwill describe the interactions between the different pathways for developing<strong>and</strong> licensing a quality protein product, examining high level issues as well asthe details that form the core of regulatory decision-making.Emily Shacter, Ph.D. Consultant, ThinkFDA, LLC;Former Chief, Laboratory of Biochemistry, CDER, US FDA4:15 Health Canada Perspective CASE STUDY High Resolution NMRFingerprinting the Higher Order Structure of Biosimilars:A Comparability ToolIn this paper, we show through a case study that a simple NMR methodcan provide detailed information on the higher order structure of proteintherapeutics. The NMR fingerprint assay applied to Filgrastim providedresidue specific information of the structure of the active ingredientof a product. In addition to current methods, the ability to assess theconformation with a high degree of resolution can greatly facilitate thecomparability exercise.Yves Aubin, Ph.D., Research Scientist, Centre for Vaccine Evaluation,Biologics <strong>and</strong> Genetic Therapies Directorate, Health Canada4:45 UNPUBLISHED DATA High-resolution NMR Analysis of ProteinTherapeutics: An Inter-laboratory Round Robin StudyHigh-resolution NMR methods can yield spectral ‘fingerprints’ related tothe structure of the bioactive form(s) of protein therapeutics at atomicresolution. This presentation reports on an inter-laboratory study aimedat establishing NMR methods for obtaining spectral ‘fingerprints’ ofprotein therapeutics <strong>and</strong> how these ‘fingerprints’ can be used to establishconsistency in drug manufacturing <strong>and</strong> for comparing a biosimilar to aninnovator reference product.John P. Marino, Ph.D., Leader, Biomolecular Structure & Function Group,IBBR-NIST5:15 CASE STUDY/UNPUBLISHED DATA Comparability Assessments LinkingClinical Trial Batches to Commercial ManufacturingChanges in scale, process chemistry or manufacturing site may suggest aneed for a comparability assessment in order to link the manufacture ofpivotal study materials to the proposed commercial manufacturing process.This presentation presents a case study around the risk assessment <strong>and</strong>Critical Quality Attributes for changes in drug substance manufacturing.Alan V. Klotz, Ph.D., Advisor, Research <strong>and</strong> Development,Elanco Animal Health, a division of Eli Lilly & Co.5:45 Close of Day Two<strong>Product</strong> <strong>and</strong> <strong>Process</strong> <strong>Variants</strong> & <strong>Impurities</strong>Development <strong>and</strong> <strong>Product</strong>ion3:45 CASE STUDY/UNPUBLISHED DATA Control of <strong>Process</strong>-Related<strong>Impurities</strong> for a Recombinant Seasonal Influenza VaccineFlublok influenza received FDA approval for the prevention of influenza inadults aged 18 to 49 in January 2013, making this product the first licensedrecombinant influenza vaccine. Our strategy regarding control of processrelated impurities <strong>and</strong> maintaining product quality for a recombinantproduct whose composition changes annually will be discussed.Penny L. Post, Ph.D., Vice President, Regulatory, Protein Sciences Corporation4:15 Analytical Considerations for Isolating <strong>Variants</strong><strong>and</strong> <strong>Impurities</strong>This talk discusses the need for developing a separate set of analytical assaysfor in-process testing, product release <strong>and</strong> product characterization; criteriafor selecting which assays can be used for which application; <strong>and</strong> examplesfrom vaccines produced in different systems.Indresh Srivastava, Ph.D., Vice President, <strong>Product</strong> Realization <strong>and</strong> SeniorProject Manager, Protein Sciences Corporation4:45 CASE STUDY/UNPUBLISHED DATA Removal of <strong>Product</strong> Related<strong>Impurities</strong> for a Recombinant Malaria VaccineThe development of highly-purified malaria vaccines remains a challenge.Using the Pfenex Pseudomonas fluorescens expression system, arecombinant vaccine was produced to support Phase I clinical trials. Themolecule was shown to be prone to rapid multimerization <strong>and</strong> N-terminaldegradation during recovery <strong>and</strong> purification. Careful attention to theexpression parameters <strong>and</strong> recovery of the vaccine protein from thebiomass were an essential components of the manufacturing process. Thedevelopment of a robust, orthogonal purification process resulted in a highyield,GMP-compliant process that generated high-quality protein that wasshown to be potent in animal models.Steven L. Giardina, Ph.D., Director, <strong>Process</strong> Analytics/Quality Control,Biopharmaceutical Development Program, SAIC-Frederick, Inc.5:15 Late-Breaking Presentation5:45 Close of Day TwoReserve Your Exhibit Booth or Sponsorship TodayThe exhibit hall for this conference has been growing annually as event attendance has increased. Reserve your booth today orcontact us to find out about opportunities to promote your product or service via sponsorship or other marketing programs.For more information, contact: Jennifer Thebodo: Tel: 508-614-1672; E-mail: jthebodo@ibcusa.comConfirmed Exhibitors (as of July 19, 2013):www.IBCLifeSciences.com/WCB www.IBCLifeSciences.com/<strong>Variants</strong> 9