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

2019年4月11~12日

 

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.

Preliminary Agenda

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

COMPARABILITY ANALYSIS

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


* 活动内容有可能不事先告知作更动及调整。

 

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