Interactive Breakout Discussion Groups

Join a breakout discussion group. These are informal, moderated discussions with brainstorming and
interactive problem solving, allowing participants from diverse backgrounds to exchange ideas and
experiences and develop future collaborations around a focused topic.  

Method Development, Qualification & Validation
Characterizing Aggregates & Impurities
Monday, March 4, 3:45-4:45pm

Protein Footprinting – HDX, FPOP and Other Approaches

Moderator: Michael L. Gross, PhD, Professor, Chemistry, Immunology and Medicine, Washington University in St. Louis

• Advantages and disadvantages of HDX
• Advantages and disadvantages of FPOP
• FPOP and other approaches vs. Synchrotron footprinting
• Role of other footprinting approaches (e.g., NEM, GEE, BHD)

Challenges in Establishing Bioassay Acceptance Criteria and Bioassay Method Validation & Transfer

Moderators: Liming Shi, MS, MA, Senior Director, Quality Control, CMAB Biopharma Inc. and

Marla Abodeely, PhD, Head, Bioassay/Immunoassay Method Development, Shire

• Stage appropriate acceptance criteria set up along with method development
• Accumulation of so-called “enough” historical bioassay data
• Both scientific and statistically sound bioassay acceptance criteria
• Challenges in bioassay method validation and transfer

Analytical Tools and Techniques for Host Cell Protein Characterization

Moderator: Christopher Yu, PhD, Principal Scientist, Protein Analytical Chemistry, Genentech, Inc.

Computational Re-Design of Protein Solubility

Moderator: Salvador Ventura, PhD, Director, Institute of Biotechnology and Biomedicine, Autonomous University of Barcelona

• The role of protein sequence
• The role of protein structure
• The role of protein stability
• The role of extrinsic factors

Advances in Characterization Methods & Approaches
Wednesday March 6, 9:35-10:35am

Challenges with Characterizations of Antibody-Drug Conjugates

Moderator: Zhiqi Hao, PhD, Scientist, Protein Analytical Chemistry, Genentech

• Current analytical technologies used to perform ADC Characterization
• Technical challenges due to the complexity associated with ADCs and how the challenges are addressed
• Application of LC-MS (MS/MS) on ADC characterization
• Phase of ADC development and regulatory requirement of characterization

Techniques for Characterizing Novel Molecules – Bispecifics and Fusion Proteins

Kevin Cook, PhD, Senior Scientist, Pharmacokinetics & Drug Metabolism, Amgen, Inc.

• How many assays are needed when a therapeutic has multiple targets?
• What are the benefits/weaknesses of “intact” and “total” assays?
• How to choose assay platform between LBA and LC-MS?

Strategies and Considerations for Characterization of Gene Therapy Products

Moderator: Xiaoying Jin, PhD, Senior Principal Scientist, Sanofi

• Characterization strategy due to material constraint
• General biochemical/biophysics characterization for gene therapy characterization
• LC-MS characterization/application

Comparability & Analytical Similarity
Friday March 8, 10:10 – 11:10am

Repeatability and Reproducibility in Higher Order Structure Analysis

Moderator: Joshua S Sharp, PhD, Asst Professor, Pharmacology, Biomolecular Sciences, University of Mississippi

• What level of repeatability and reproducibility in higher order structure analysis is necessary (or meaningful)?
• How should repeatability/reproducibility requirements change at different levels of product development (discovery vs. development vs. biosimilar equivalency testing)?
• What level of repeatability/reproducibility in higher order structure analysis is feasible with current technology?
• What are the current bottlenecks in achieving the desired level of repeatability/reproducibility in higher order structure analysis?

The Study of Biologics Structure and Immunogenicity Correlation with Novel Technologies

Moderator: Xing Wang, PhD, President, Array Bridge, Inc.

• What are the technologies available to study correlation between biologics structure and immunogenicity?
• What are the pros and cons for each of the technologies?
• What kind of assays are available?
• What are the pros and cons for those assays?

Analytical Comparability for Innovator and Biosimilar Products - How Much Is Enough?

Moderator: Sonia Taktak, PhD, Principal Scientist, Analytical R&D, Biotherapeutics Pharmaceutical Sciences, Pfizer, Inc.

• How should one design a comparability study in early/late stage development vs commercial?
• Should there be a comparability plan with pre-determined acceptance criteria?
• What stability/stress studies need to be included in comparability studies?
• Should one use statistics for assessing comparability/evaluating rates or routes of degradation?