Plasmid DNA is a critical starting material in the production of many advanced therapies including viral vectors and RNA vaccines; manufacturing plasmid DNA to support these therapies brings with it both supply chain and regulatory challenges for product developers. As the number of products in development increases, and with more products entering late clinical phase development, companies are being required to develop strategies to address these needs from a commercial and regulatory perspective.
This webinar will address the technical challenges around plasmid production, emerging regulatory guidelines, and offer up phase dependent approaches to plasmid supply for product developers, such as HQ (High Quality) plasmid DNA:
- Plasmid production including processing and testing
- Regulatory requirements
- Phase dependent approaches
Cobra Biologics, A Charles River Company
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