Product and Process Variants & Impurities

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Tuesday, October 22, 2013 (continued)Well Characterized Biologicals1:30 Chairman’s RemarksZiping Wei, Ph.D., Executive Director, Novavax, Inc.Characterization and Comparability of Vaccines1:45 FDA Perspective Regulatory Considerations in the SafetyAssessment of Vaccine Adjuvants and Adjuvanted VaccinesThis presentation provides background information on vaccine adjuvantsand adjuvanted preventive and therapeutic vaccines for infectious diseaseindications; present an overview of vaccine adjuvants under investigationand in U.S.-licensed vaccines; and delineates the regulatory considerationsfor the nonclinical and clinical safety evaluation of investigational vaccinescontaining novel adjuvants.Carmen M. Collazo-Custodio, Ph.D., Microbiologist, Primary Reviewer,Division of Vaccines and Related Product Applications, CBER, US FDA2:15 CASE STUDY/UNPUBLISHED DATA Analytical CharacterizationStrategies and Challenges of Protein Vaccine ProductsAn enhanced approach to product development requires building productunderstanding throughout the development lifecycle. The focus of thispresentation is on analytical characterization strategies and challengesduring protein vaccine development. Case studies are provided to elucidatethe value of characterization studies and orthogonal tools for virus-likeparticle and 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 and 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 and 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 Sandy), the conference went on and I had awonderful experience attending”– Wing-Yee Fu, Associate Scientist, Momenta Pharmaceuticals“…Very relevant with current events and trends. Itprovided a good arena to network and share ideas andbest practices.”– John Alvino, Manager, MedImmuneProduct and Process Variants & ImpuritiesAggregation and Subvisible ParticlesFeatured Presentation10:45 Practical Considerations to Characterize andControl Protein Aggregates During theDevelopment Cycle and 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 and setting specifications and QbD expectations.Erwin Freund, Ph.D. Scientific Executive Director, Drug ProductEngineering, Amgen Inc.11:15 UNPUBLISHED DATA Subvisible Particles and Associated Impacton Virus-Retentive Filter PerformanceTo ensure safety of antibody drug products, regulatory agencies requiresteps to ensure the removal of endogenous and 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 and explore methodologies todevelop robust processes for commercial scale production.Christopher Cowan, Ph.D., Staff Engineer, Preclinical ManufacturingProcess 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 and Exhibit/Poster Viewing1:30 Chairman’s Opening RemarksWayland Rushing, Ph.D., Senior Scientific Advisor, ABC Laboratories1:45 UNPUBLISHED DATA Understanding 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 and elongated. We have fabricated monodisperse polymerparticles of various shapes to understand the response of particle counters tonon-spherical particles. Detection technology considered includes: the human eye,electrical sensing zone (Coulter counter), light obscuration, and flow imaging.Michael Carrier, Bioprocess Measurements Group, National Institute ofStandards and Technology2:15 CASE STUDY Understanding and Implementing EffectiveExtractable and Leachable ProgramsImpurities 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 and efficacy. Understandingthe potential sources of these compounds and the analytical tools to detectthem can be vital to a development program. Designing and implementing anextractables and leachables program can save significant time/cost in developmentand potentially avoid pitfalls, which may increase time to market.Wayland 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 and needto be monitored. The identification and quantitation of low-level HCPs inbiopharmaceuticals using two-dimensional chromatography and 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 and Exhibit/Poster Viewing8 www.IBCLifeSciences.com/WCB Variant and www.IBCLifeSciences.com/VariantsImpurity Challenges in Vaccine
Tuesday, October 22, 2013 (continued)Well Characterized BiologicalsComparability Strategies for Biotechnology Products3:45 Similarity and Comparability: What’s in and What’s out?Biosimilar and novel protein products have overlapping but distinct criteriafor successful development, licensure, and post-approval changes. This talkwill describe the interactions between the different pathways for developingand 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 and 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 and how these ‘fingerprints’ can be used to establishconsistency in drug manufacturing and 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 andCritical Quality Attributes for changes in drug substance manufacturing.Alan V. Klotz, Ph.D., Advisor, Research and Development,Elanco Animal Health, a division of Eli Lilly & Co.5:45 Close of Day TwoProduct and Process Variants & ImpuritiesDevelopment and Production3:45 CASE STUDY/UNPUBLISHED DATA Control of Process-RelatedImpurities 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 and 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 Variantsand ImpuritiesThis talk discusses the need for developing a separate set of analytical assaysfor in-process testing, product release and product characterization; criteriafor selecting which assays can be used for which application; and examplesfrom vaccines produced in different systems.Indresh Srivastava, Ph.D., Vice President, Product Realization and SeniorProject Manager, Protein Sciences Corporation4:45 CASE STUDY/UNPUBLISHED DATA Removal of Product RelatedImpurities 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 and N-terminaldegradation during recovery and purification. Careful attention to theexpression parameters and 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, Process 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/Variants 9
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