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Gene Therapy CMC & Analytics - EST/EDT (Eastern Daylight, GMT-4)
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Gene Therapy CMC & Analytics - EST/EDT (Eastern Daylight, GMT-4)
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Showing 1 of 1 Streams
Gene Therapy CMC & Analytics
08:30 - 08:35
Opening Remarks
08:35 - 09:35
Regulatory Considerations for Gene Therapy Analytics
09:35 - 10:05
Navigating regulatory expectations and challenges with gene therapy products
10:05 - 10:35
Networking Break
10:35 - 11:05
Strategies to Overcome the CMC material Requirements
11:05 - 11:35
Advanced Characterization of DNA Molecules in rAAV Vector and Plasmid DNA manufacturing Preparations by Next Generation Preparations Sequencing
11:35 - 12:05
Networking Break
12:05 - 12:35
Full and Empty Capsids: Product-Related Impurities
12:35 - 13:05
Capsid Characterisation
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