Cambridge Healthtech Institute’s Inaugural
Analytical Support for Drug Product Development
( 药物开发的分析面支持 )
Overcoming the Analytical and Formulation Challenges of a New Generation of Drug Products
Advances in protein science, drug combinations, delivery technology and analytical methods are supporting an unprecedented wave in novelty in the design of biologic drug products. With these new products comes the urgent need for analytical support of product development, regulatory filings and manufacturing – in ways that require a constant adaptation by analytical and formulation groups to new modalities and technologies. New for 2019, the PEGS Analytical Support for Drug Product Development provides a best practices exchange for scientists now working to develop these new products – or for those wishing to be prepared for forthcoming programs in their organization’s pipelines.
KEY ASSAYS AND ISSUES IN DRUG PRODUCT DEVELOPMENT
Developability Evaluation: Right Tools at the Right Time?
Rachana Shah, PhD, Scientific Leader, Drug Design and Selection, GlaxoSmithKline, United Kingdom
Approaches to Optimizing the Manufacturability of Monoclonal Antibodies
John Liddell, PhD, Senior Scientific Advisor, National Biologics Manufacturing Centre, Centre for Process Innovation, United Kingdom
Characterizing Product Specific Host Cell Proteins
Jennifer Kessler, Senior Development Associate, MacroGenics, Inc.
Phase Appropriate Potency Assays: What Is Needed and When?
Sheila G. Magil, PhD, Principal Consultant, BioProcess Technology Consultants, Inc.
DRUG PRODUCT DEVELOPMENT CHALLENGES
Development of Co-Administered and Fixed Dose Combinations of Two mAbs
Tarik Khan, PhD, Senior Scientist, Late-Stage Pharmaceutical and Processing Development, F. Hoffmann-La Roche Ltd., Switzerland
Tools for Developing a Mechanistic Understanding of Specificity in Post-Translational Modification Targeting Antibodies
Yongku Cho, PhD, Assistant Professor, Chemical and Biomolecular Engineering, University of Connecticut
Protein Engineering for Improved Developability
Qing Chai, PhD, Principal Scientist, Eli Lilly & Co
IV Set Compatibility Studies for ADCs
Alexandra (Sasha) Zaitsev, Development Associate, ImmunoGen
Device Considerations in Drug Product Development – Case Study of Ophthalmic Injections of Anti-VEGF Therapies
Susan Dounce, PhD, Principal SME, Prefilled Syringes, West Pharmaceutical Services
Oligomericity Status Changes and its Effects on the Stability of Proteins in Solution
Bettina Bommarius, PhD, Senior Research Scientist, Chemical and Biomolecular Engineering, Georgia Institute of Technology
Method Bridging: Fit or Mis-fit
Abbie Esterman, PhD, Senior Scientist, Methods and Analytical Development, Bristol-Myers Squibb
The Challenges of Comparability Testing Scenarios; Clinical Stages, Manufacturing Sites, Process/Product Changes
Vijay Dhawan, PhD, Associate Director, Sanofi
ANALYTICAL ISSUES IN QUALITY AND PROCESS CONTROL
Development of Process and Product Understanding: Use of Prior Knowledge and Challenges for Setting of Specifications
Gerald Gellermann, PhD, Senior Fellow, Novartis, Switzerland
Theoretical Constraints on Design Space for High Concentration Filling: Minimizing Clogging and Increasing Filling Precision
Richard Galas, PhD, Senior Scientist, Takeda