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X-WR-CALDESC:Events for Pharma Journalist
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DTSTART;VALUE=DATE:20210330
DTEND;VALUE=DATE:20210402
DTSTAMP:20260515T163040
CREATED:20201202T152441Z
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SUMMARY:Gene Therapy Comparability
DESCRIPTION: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. \nThis 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. \n \nFocused 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. \nIncorporating 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. \nJoin your peers online and discover: \n\nHow Biogen defined a robust comparability strategy for late phase gene therapy products\nGain 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\nHear from the National Institute of Biology and discover if results of non-related analytical methods can be directly compared\nLearn from the Italian Medical Agency and take a deep dive into regulatory expectations for ATMP comparability and comparability exercises\nExplore next generation sequencing (NGS) and how its application can be utilized for comprehensive rAAV genome characterization with Biogen\nBetter 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\n\nView the full event guide to find out more!
URL:https://www.pharmajournalist.com/event/gene-therapy-comparability/
LOCATION:Digital Event
ORGANIZER;CN="Hansonwade":MAILTO:info@hansonwade.com
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