Pioneer Effective CMC & Analytical Comparability Studies to Maintain Safety, Quality & Efficacy at Every Stage of Manufacturing
The inaugural Gene Therapy Comparability Summit is the only industry dedicated meeting to ensuring your manufacturing processes are effective and comparable at every stage of development, supporting a seamless transition to the larger scales required for commercialization.
This meeting will unite large pharma and innovative biotechs including Pfizer, Biogen, BioMarin and Takeda as they share best practices, lessons learned and analytical data across the comparability lifecycle.
Focused specifically on enhancing your gene therapy comparability approach, join us to ensure you maintain safety, quality, consistency and efficacy throughout scale-up from clinical to commercial-scale manufacturing, and satisfy regulatory demands to avoid costly delays to clinical programs.
Incorporating insights from leading CMC, Regulatory, Analytical and Process Development experts, this is your opportunity to gain extensive technical information on challenges like ensuring manufacturing processes are comparable when changing facilities and cell lines, developing effective bioassays for use in comparability studies and handling the limited gene therapy lots available.
View the full event guide here to see the full agenda, speaker faculty and more!
Previous Gene Therapy attendees have said:
“Inspiring virtual meeting allowing efficient learning about the most recent advances in gene therapy immunogenicity while still having interactions with peers.”
Cornelia Ciorciaro, Director - Safety Science Group Medical, Roche
“It was great to have a conference focused on analytical challenges for testing immune markers and modulating immune responses to gene therapies.”
Michele Stone, Vice President - Translational Development, Kriya Therapeutics
“I learned a lot about the what, who & how of the AAV gene therapy field.”
Robert J Kubiak, Clinical Pharmacologist, AstraZeneca
What Will You Learn?
A robust comparability strategy for late phase gene therapy products
Insights into the planning and considerations for a comparability study and risk assessment
What defines process comparability vs analytical comparability
Regulatory expectations for ATMP comparability and comparability exercises
Next generation sequencing (NGS) and how its application can be utilized for comprehensive rAAV genome characterization
The challenges associated with limited batch retention and sample availability in the context of comparability and learn best practices for mitigating such challenges