Analytical Development 101 Day
Monday, November 29 2021 | 10.00AM - 2.00PM EST
Looking to understand basic principles and familiarize yourself with key terms and technologies?
Look no further than the 101 Day at Gene Therapy Analytical Development where you will learn the important foundations to the analytical development field, preparing you and increasing your confidence in the discussion that lie in the deeper-dive days ahead!
10.00 Next Generation Analytical Characterization of Gene Therapy Vectors
- On top of the challenges GT companies are already facing in developing the analytical "tool kit" for gene therapy vectors, more companies will be facing new challenges in meeting Late Phase expectations for analytical characterization and release testing
Elizabeth Higgins
Vice President CMC
NysnoBio
What are the Assays?
An introduction to the individual assays used in gene therapy analytical development, discussing the advantages and limitations of each, and how they compare to protein analytics
10.30 Bioassays
- An introduction to the bioassays required: what does each assay mean?
- What technologies are being used for analysis?
- In vivo vs in vitro bioassays
- Highlighting standards and controls
Vess Mitaksov
Senior Principal Scientist
Pfizer
11.00 Molecular Biology
- PCR-based applications for the characterization of aav gene therapy vectors
- Brief overview of qPCR vs. ddPCR
- Applying PCR-based methods to characterize AAV vectors
Peter Clarner
Scientist, Gene Therapy Accelerator Unit
Biogen
11. 30 Lunch Break
12. 30 Round Table Discussion
Chair:
Cecilia Della Valle
Associate Director
PTC Therapeutics
Elizabeth Higgins
Vice President CMC
NysnoBio
Peter Clarner
Scientist, Gene Therapy Accelerator Unit
Biogen
Vess Mitaksov
Senior Principal Scientist
Pfizer