Gene Therapy Comparability
March 30, 2021 - April 1, 2021 - KS USHanson Wade
info@hansonwade.com
Phone:+44 020 3141 8700
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. Join your peers online and discover: - How Biogen defined a robust comparability strategy for late phase gene therapy products - Gain insights into the planning and considerations for a comparability study and risk assessment and understand what defines process comparability vs analytical comparability with Amicus Therapeutics - Hear from the National Institute of Biology and discover if results of non-related analytical methods can be directly compared - Learn from the Italian Medical Agency and take a deep dive into regulatory expectations for ATMP comparability and comparability exercises - Explore next generation sequencing (NGS) and how its application can be utilized for comprehensive rAAV genome characterization with Biogen - Better understand the challenges associated with limited batch retention and sample availability in the context of comparability and learn best practices for mitigating such challenges with Gyroscope Therapeutics Visit our website and view the full event guide for more information: www.genetherapy-comparability.com