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?