Product and Process Variants & Impurities

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Well Characterized Biologicals 8:30 Chairman’s Remarks Michael G. Mulkerrin, Ph.D., Vice President, Process Development, OncoMed Pharmaceuticals Characterization of Novel Antibody Constructs and Monoclonal Antibodies 8:45 UNPUBLISHED DATA Physicochemical Characterization of Maytansinoid ADCs Manufacturing of maytansinoid ADCs using ImmunoGen’s technology relies on the attachment of the cytotoxic agent molecules (DM1 or DM4) via a linker to amino groups on antibodies. This attachment changes some of the properties of the antibody molecules. This presentation will describe development and implementation of an appropriate panel of analytical techniques for release and characterization of maytansinoid ADCs. Alex Lazar, Ph.D., Head of Analytical and Pharmaceutical Sciences, ImmunoGen, Inc. 9:15 UNPUBLISHED DATA Strategy for the Characterization of Bispecific Antibodies Bispecific Antibodies are a class of therapeutics gaining in prevalence. Advances in protein engineering are generating a number of solutions for the generation of bispecific antibodies. There are common challenges in the manufacture of these molecules, which include quantitating the amount of the homodimer and heterodimer and characterizing the nature of unwanted variants. This presentation will discuss the strategy and analytical approaches to characterize bispecific antibodies. Michael G. Mulkerrin, Ph.D., Vice President, Process Development, OncoMed Pharmaceuticals 9:45 CASE STUDY Analytical Characterization Strategies for Bispecific Molecules and Novel Antibody Constructs Bispecific antibody-like molecules and other formats investigated present new therapeutic opportunities. However, analytical challenges are encountered when adopting platform monoclonal antibody formats to evaluate these complex molecules. In this presentation we will highlight a few case studies to illustrate our approach to studying antigen binding and other pharmaceutical properties of these molecules. Leslie T. Alessandri, Senior Scientist II, Protein Analytics, AbbVie Bioresearch Center 10:15 Networking Refreshment Break and Exhibit/Poster Viewing 10:45 Development of a Flow-through Dialysis System – A Novel Approach in Evaluating Biological Relevance of Recombinant Proteins For recombinant proteins, understanding of in vivo behavior of product variants is important and desirable but often is very challenging to achieve. In this presentation, we describe the development of an in vitro flow-through dialysis system to mimic in vivo behavior of disulfide isoforms in monoclonal antibodies and Fc-fusion proteins. The system is capable of maintaining a low level redox concentrations found in human blood. Using this system, we studied the conversion kinetics of disulfide variants in vitro under physiological conditions. Gang Huang, Ph.D., Scientific Director, Process and Product Development, Amgen, Inc. 11:15 CASE STUDY/UNPUBLISHED DATA Characterization of an Fc Fusion Protein Therapeutic Candidate: Lessons Learned, Experiences and Future Challenges An Fc fusion protein therapeutic comprised of a receptor extracellular domain (ECD) fused with the Fc portion of an IgG1 antibody was analyzed by multiple methods to confirm the predicted structure and establish the product profile. The ECD, containing two additional N-linked glycosylation sites as well as a disproportionately high number of acidic amino acids, afforded some unique analytical challenges. The particular challenges confronted by Fc-fusion product candidate characterization will be discussed. James Bourell, Senior Scientist, Process Development, OncoMed Pharmaceuticals Reference Standards for Biologicals 11:45 Regulatory Perspectives on the Use of Reference Standards for Licensed Therapeutic Proteins Ashutosh Rao, Ph.D., Product Quality Reviewer, Division of Therapeutic Proteins, CDER, US FDA Monday, October 21, 2013 7:00 Registration and Coffee Product and Process Variants & Impurities 8:00 Chairman’s Opening Remarks David Ouellette, Senior Scientist II, Protein Analytics, Process Sciences, AbbVie Bioresearch Center Featured Presentation 8:15 The Challenges of Product- and Process-Related Impurities to an Evolving Biopharmaceutical Industry C. Mark Smales, Centre for Molecular Processing & School of Biosciences, University of Kent, United Kingdom Analytical Methods and Technologies for Identifying and Controlling Product-Related Variants and Impurities 8:45 Optimizing Host Cell Protein Assay to Enable Rapid Process Development Abstract not available at time of print. Please visit www.IBCLifeSciences.com/Variants for updates. Brett Carter, Associate Scientist, MedImmune 9:15 Stable Isotope-Tagged Reference Standards for Detection of Sequence Variants and PTMs The current analytical methods that are used to identify the presence of mutations or modifications in an antibody sample may not always be able to detect these changes when they are present at a low level. A quantitative mass spectrometry-based approach, the SITRS method, was developed and further optimized to identify these minute differences down to 1%. Fully-automated data analysis enables high resolution comparability of therapeutic proteins at the peptide level without a prior knowledge of the presence or nature of the variant. The utility of the SITRS method in discovering and quantitating sequence variants and PTMs will be demonstrated by specific case studies. Anton V. Manuilov, Ph.D., Senior Scientist II, Protein Analytics, AbbVie Bioresearch Center 9:45 Use of Standard Analytical Tools for Screening Product Variants During Candidate Selection of Antibodies Manufacturing well-characterized biologics has become an expectation for antibody and bispecifics production within the biotech industry. Analytical methods that examine physicochemical properties of molecules when screening multiple candidates are helpful in identifying sequence liabilities. This information is important for identifying candidates with appropriate shelf life, desired quality attributes and ensuring manufacturing consistency during clinical development. David Ouellette, Senior Scientist II, Protein Analytics, Process Sciences, AbbVie Bioresearch Center 10:15 Networking Refreshment Break and Exhibit/Poster Viewing 10:45 CASE STUDY/UNPUBLISHED DATA Mutation Detection and Discovery by the Nucleic Acid Technologies Sequence variants as a product quality attribute needs to be analyzed for pharmaceuticals generated by recombinant technology. Mutations at the DNA level can lead to protein sequence variants and may not change the amino acid coding. Nucleic acid technologies allow earlier detection of mutations, and serve as complementary tools to sequence variant analysis at the protein level. Judith Shimoni, Ph.D., Senior Scientist / Group Leader, Protein Analytical Chemistry, Genentech 11:15 CASE STUDY/UNPUBLISHED DATA Assess Product-Related Variants by Targeted Multi-Dimensional Characterization Methods Monoclonal antibodies (mAbs) are well characterized proteins and established as the most promising drug classes in the biopharmaceutical industry. This talk discusses a balanced strategy to assess product-related variants of mAbs in early stage as part of the QbD approach. Case studies will be used to elucidate the application of the strategy in evaluating potential product-related variants of mAbs. Wei Xu, Ph.D., Principal Scientist, Bioprocess Development Extended Characterization, Merck Research Laboratories 11:45 Presentation Sponsorship Opportunity For more information on sponsored opportunities to present an exciting technology or application in this conference session, please contact Jennifer Thebodo at jthebodo@ibcusa.com 4 www.IBCLifeSciences.com/WCB www.IBCLifeSciences.com/Variants
Monday, October 21, 2013 (continued) 12:15 Networking Luncheon and Exhibit/Poster Viewing with “Hot Topic” Roundtable Discussions Please join us during this afternoon’s luncheon for informal, “hot topic” roundtable discussions moderated by conference speakers. To suggest a topic you would like to discuss, please email Michael Keenan at mkeenan@ibcusa.com. Confirmed Discussion Topics and Moderators: What Are Requirements for Highly Similar and Fingerprint-Like Biosimilars? Andreas Seidl, Ph.D., Head, Analytical Characterization and Site Head, Sandoz Biopharmaceuticals, Hexal AG, Sandoz Biopharmaceuticals, Germany Regulatory CMC Considerations for Phase 2b and Phase 3 Vaccines Cara Fiore, Ph.D., Master Reviewer, Office of Vaccines Research and Review, CBER, US FDA Regulatory Considerations in the Safety Assessment of Vaccine Adjuvants and Adjuvanted Vaccines Carmen M. Collazo-Custodio, Ph.D., Microbiologist, Primary Reviewer, Division of Vaccines and Related Product Applications, CBER, US FDA Analytical Characterization Strategies and Challenges of Protein Vaccine Products Ziping Wei, Ph.D., Executive Director, Novavax, Inc. Utilization of Forced Degradation Data in Product Regulatory Filings Nadine M. Ritter, Ph.D., Senior CMC Consultant, Biologics Consulting Group Bridging from Old To Modern Potency Assays: How Much Bridging Data is Sufficient and are We Measuring the Right Attributes? Maura C. Kibbey, Ph.D., Senior Scientific Liaison, Biologics & Biotechnology, US Pharmacopeia Comparability Strategies Alan V. Klotz, Ph.D., Advisor, Research and Development, Elanco Animal Health, a division of Eli Lilly & Co. High End Characterization of Biosimilars (Using NMR , XRD) – a Scientifically Justified Requirement or a Check Box? Sridevi Khambhampaty, Ph.D., Director, Product Characterization and Bioanalytical Development, Dr. Reddy’s Laboratories Ltd., India Modern Molecular Methods for Impurity and Contamination Analysis Wesley Straub, Senior Product Manager, Bioproduction, Life Technologies Well Characterized Biologicals 1:30 Chairman’s Remarks Andreas Seidl, Ph.D., Head, Analytical Characterization and Site Head, Sandoz Biopharmaceuticals, Hexal AG, Sandoz Biopharmaceuticals, Germany CMC Strategies for Biosimilars 1:45 FDA Perspective Update on the United States Biosimilars Program FDA continues to receive applications to the abbreviated licensure pathway afforded by section 351(k) of the Public Health Service Act which permits a biosimilar biological product to be licensed on less than a full compliment of product-specific preclinical and clinical data. This talk provides an overview of the biosimilars program at FDA and discusses emerging technical considerations to assure safe and efficacious biosimilar products. Jeffrey C. Baker, Ph.D., Deputy Director, Office of Biotechnology Products (OBP), CDER, US FDA 2:15 CASE STUDY/UNPUBLISHED DATA Characterization Strategies for Demonstration of Biosimilarity Thorough characterization of a biosimilar candidate in comparison with the reference product is the basis for a targeted clinical development program. FDA biosimilar guidelines suggest not only to analyze isolated quality attributes but also to focus on combinations of quality parameters. This presentation will give an overview about characterization strategies for biosimilars and will also provide case studies on quality attribute combinations and the impact on structure/function. Andreas Seidl, Ph.D., Head, Analytical Characterization and Site Head, Sandoz Biopharmaceuticals, Hexal AG, Sandoz Biopharmaceuticals, Germany 2:45 CASE STUDY/UNPUBLISHED DATA Characterization of Charge Variants in Monoclonal Antibodies: Case Study of a Proposed Rituximab Biosimilar Characterization In this presentation, the case study of a proposed rituximab biosimilar along with the innovator product demonstrates a detailed characterization of the charge variant profile for a Mab. The characterization approach uses peptide map LCMS and reduced LCMS techniques to arrive at the identification of the charge isoforms. In addition, the functional assessment of the isolated and purified charge variants will be shown to demonstrate any functional relevance of these changes. Sridevi Khambhampaty, Ph.D., Director, Product Characterization and Bioanalytical Development, Dr. Reddy’s Laboratories Ltd., India 3:15 Networking Refreshment Break and Exhibit/Poster Viewing Product and Process Variants & Impurities 1:30 Chairman’s Opening Remarks Jason C. Rouse, Ph.D., Director, Mass Spectrometry and Biophysical Characterization, Analytical Research and Development, Biotherapeutics Pharmaceutical Sciences, Pfizer, Inc. Analytical Methods and Technologies for Identifying and Controlling Product-Related Variants and Impurities (continued) 1:45 Rapid Mass Spec Approach for Monitoring Process Impurities and CQAs This presentation focuses on the utility of peptide and glycan mapping strategies for identifying and monitoring product variants and critical quality attributes. A particular emphasis is placed on informatics tools which provide efficiency gains in product variant identification. IgG2 and IgG1 molecules are used as representative material. Justin Prien, Ph.D., Senior Scientist, Process and Product Engineering, Amgen Inc. 2:15 The Ever-Changing “Characterization Roadmap” for Protein Therapeutics: Integration of New Technologies for Increased Product Understanding and Speed Contemporary mass spectrometers offer significant improvements in critical performance parameters such as resolution, mass accuracy, and sensitivity, thereby, enabling new approaches to protein characterization. Ultrahighresolution MS, in combination with UHPLC and the FabRICATOR® enzyme, have led to a highly resolving, antibody subunit mapping method that rivals traditional peptide mapping in terms of rapid confirmation of the expected amino acid sequence and post-translational modifications. Jason C. Rouse, Ph.D., Director, Mass Spectrometry and Biophysical Characterization, Analytical Research and Development, Biotherapeutics Pharmaceutical Sciences, Pfizer, Inc. Process Monitoring and Control Strategies for Purifying Variants and Impurities 2:45 CASE STUDY Variations in the Glycosylation of Biopharmaceuticals: Approaches to Controlling the Pathways and Analyzing the Glycans Glycosylation pathways are determined at many levels from the genome to the proteome and by the environment of the cells in culture. Glycans have an influence on the safety and efficacy of many biological drugs, so it is necessary to understand the outcome that is relevant to the mode of action of the product. There are many possibilities for manipulating the glycosylation pathways and to monitor the interventions and some of these will be discussed in this talk. Pauline M. Rudd, Ph.D., NIBRT Research Professor, Dublin-Oxford Glycobiology Laboratory, NIBRT, Ireland 3:15 Networking Refreshment Break and Exhibit/Poster Viewing www.IBCLifeSciences.com/WCB www.IBCLifeSciences.com/Variants 5
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