Case Study: Sustainable Plasmid DNA Strategies

With many advanced therapy products reaching commercialization and an ever-increasing pipeline planned for transition to late phase clinical studies, there is significant demand for reliable plasmid DNA supply. In addition, evolving and sometimes undefined regulatory requirements and quality standards present a range of opportunities and challenges for developers.

In this webinar, we are joined by Amanda Weiss, VP CMC, Purespring Therapeutics, whose team is developing the first gene therapy platform to specifically target kidney diseases. She presents a case study and highlights key lessons learned that can help developers set themselves up for success when working with CDMOs.

Andrew Frazer, Associate Director, Scientific Solutions, also explores some of the common challenges encountered when sourcing plasmid DNA and provides valuable recommendations to achieve sustainable plasmid supply to support clinical programs to market.

Learn:

• Common pitfalls and regulatory guidance when outsourcing plasmid DNA
• Key considerations to support long-term program delivery
• How to set yourself up for success when working with CDMOs