Strategies for minimizing the impact of stability testing on gene therapy batch yield

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It is acknowledged that gene therapy manufacturing processes often result in low yields, especially in the early stages of product development.
Gene therapy products, however, are largely subject to many of the same regulatory requirements and expectations as other large molecule biopharmaceuticals, which are produced at much greater scales.
In terms of stability studies, this situation means that if gene therapy manufacturers adhere to common paradigms, the outcome would often be little, if any, remaining product for patients or studies to support investigational new drug applications.
By presenting a concrete case study and discussing the available mitigation strategies, this webinar will provide clear guidance on how to minimize the impact of stability studies on batch yield and maximize the amount of material available for the patients.
If you are in QC, QA, regulatory, or CMC leadership, this webinar will help you avoid getting lost in generic considerations that may not be relevant to your product and guide you to apply them specifically to gene therapies.
Our speakers 🗣️
Gael Debauve, Head of Gene Therapy CMC Analytics, ‪@ucbofficial‬
Chapters:
0:00 Webinar and BioPhorum introduction
6:23 The problem and benchmarking survey
15:15 Mock product and assumptions
18:49 Baseline strategy
22:58 Opportunities for protocol optimization
27:42 Optimized stability program
29:55 Conclusion
#CGT #genetherapy #Stability #BioPhorum #advancedtherapy #advancedtherapies #AdvancedTherapyMedicinalProducts