Characterization and Compliance focuses on application of advanced analytical technologies throughout development. It presents characterization of the complex heterogeneity of ADCs by means of sophisticated technologies such as new inductively-coupled plasma mass-spec ICP-MS, capillary electrophoresis and protein mass spectrometry. A range of technologies for aggregate characterization will also be presented together with an FDA study on pathways that lead to aggregation. Because host cell proteins have become very hot, we have included a presentation (and short course) on the most advanced technologies for their characterization. Practical case studies on control and monitoring of Critical Quality Attributes and on phase-specific characterization will be presented.Reference standards for product quality and manufacturing consistency will be presented by the FDA and backed up with examples from NIST and a case study from the industry. Regulatory issues are further addressed by regulatory and FDA on concerns such as reference standards, product comparability and the new topic of mycoplasma detection.
Regulative Perspectives on the Use of Reference Standards in the Development of Therapeutic Proteins
Baolin Zhang, Ph.D. Senior Investigator, Therapeutic Proteins, Office of Biotechnology Products, CDER / FDA
The NIST mAb: A Reference Material to Supplement Biopharmaceutical Characterization and Compliance
John E. Schiel, Ph.D., Research Chemist, Biomolecular Measurement Division, NIST
Strategy for Building an In-House Reference Standard System for Early Development through to Commercialization
Michael Huang, Ph.D., Senior Scientist, Analytical Biotechnology, Biopharmaceutical Development, MedImmune
New Approaches to Characterization of Specific Products such as ADCs and Interferons
Igor Kaltashov, Ph.D., Associate Professor, Chemistry, University of Massachusetts
Overcoming Analytical Challenges in Characterization of Heterogeneities of Antibody Drug Conjugates
April Xu, Ph.D., Senior Principal Scientist & Group Leader, BioTx – Analytical R&D, Pfizer, Inc.
Imaging of Next Generation Bi-Specifics to Reveal Antigen-Binding and Product Dynamics
Czeslaw Radziejewski, Associate Director, Protein Analytics, Process Sciences, Abbvie
CHARACTERIZATION AND CONTROL OF SUB-VISIBLE PARTICLES AND AGGREGATES
Assessing Aggregation of Therapeutic Proteins in Human Plasma
Shen Luo, Ph.D, Senior Staff Fellow, Therapeutic Proteins, Office of Biotechnology Products, CDER/FDA
Development of Mass Spectrometry-Based Approaches to Study the Dimerization of Therapeutic Monoclonal Antibodies
Shunhai Wang, Ph.D., Scientist, Analytical Chemistry, Regeneron Pharmaceuticals, Inc.
Reversible Self-Association and Stability in a Monoclonal Antibody
Julie Wei, Ph.D., Scientist II, Protein Pharmaceutical Development, Biogen Idec, Inc.
Application of Different Approaches for Assessment of HCPs: Traditional Immunoassays, Mass Spec and a Proteomic Approach
Martin Vanderlaan, Ph.D., Director, Analytical Operations, Genentech
Case Study on Control and Monitoring of Critical Quality Attributes during Process and Product Development
Tamer Eris, Principal Scientist, Attribute Sciences, Amgen, Inc.
Regulatory Guidance on Phase Specific Characterization
Emily Shacter, Ph.D., Consultant, ThinkFDA
Integration of Product Comparability into Process Development Strategies to Ensure Regulatory Approval
Alain Bernard, VP, Technical Operations GPS, UCB Pharma
A Regulatory Perspective on the Detection of Mycoplasma in Biotechnology Products
Laurie Graham, Ph.D., Product Quality Reviewer, Monoclonal Antibodies FDA/CDER
Case Studies on Phase-Specific Characterization of Therapeutic Proteins
Ping Feng, Ph.D., Director, Analytical Sciences, Biological CMC, Teva Pharmaceuticals, Inc.
For questions about the meeting, please contact:
Nicole Lyscom, Ph.D.
Cambridge Healthtech Institute
Phone: +44 7791 866489
For partnering & sponsorship information, please contact:
Manager, Sponsorship & Exhibits
Cambridge Healthtech Institute