Sustainable plasmid DNA strategies: achieving streamlined, secured supply to clinic and commercialization
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, Andrew Frazer (Associate Director, Scientific Solutions, Charles River Laboratories) will explore some of the common challenges encountered when sourcing plasmid DNA, and provide valuable recommendations that will help navigate common pitfalls to achieve sustainable plasmid supply to support clinical programs to market. Additionally, Amanda Weiss (VP CMC, Purespring Therapeutics), part of a team developing the first gene therapy platform to specifically target kidney diseases, will present a case study and highlight key lessons learned to help developers set themselves up for success when working with CDMOs.
Common challenges and regulatory guidance for sourcing plasmid DNA
Key aspects of plasmid supply that you need to consider
How to plan your plasmid supply to support long-term program delivery
Associate Director, Scientific Solutions, Charles River Laboratories
Since earning his PhD in biochemistry from Queen’s University Belfast, Andrew has attained over 10 years of experience in the design, implementation, and tech-transfer of processes for the manufacture of biocatalysts, small molecule APIs, and biologics. In his current commercial role, Andrew focuses on the Charles River plasmid DNA manufacturing platform, eXpDNA™, and plasmid CDMO service offering.
Vice President CMC, Purespring Therapeutics
Amanda Weiss is the VP of CMC at Purespring Therapeutics, a kidney gene therapy company. Prior to this she was responsible for Validation & Commercialisation for the lead ophthalmology product, Choroideremia, at Nightstar, a retinal disease gene therapy company, and also at Biogen post Nightstar’s acquisition. She has over 27 years of industrial experience in the development, manufacture, and analysis of biological products and has held posts at both product development companies and CDMOs. She trained as a Biochemical Engineer at the University of Birmingham.