Expediting development and manufacture of advanced therapies: critical starting materials case study

Live30 webinars are thirty-minute presentations designed to update you on the latest innovations, applications, and data in a fast yet interactive format.

With 27 FDA-approved cell and gene therapy products to date, plus many on the horizon, plasmid DNA continues to play a crucial function within advanced therapies medicinal product (ATMP) development, both as a direct therapeutic and as a critical starting material where it contributes to the quality and function of drug products.

Dedicated to supporting developers as they navigate the complex path to clinic, and in response to increased demand, Charles River’s integrated plasmid CDMO service offering has expanded. This now includes a broader range of screening options, predictable platform manufacturing for phase-appropriate High Quality (HQ) and GMP grade plasmids, and an off-the-shelf plasmid product portfolio to reliably support viral vector manufacture, with 100% in-house testing for supply chain simplification.

This webinar will review the role of plasmid DNA as a critical starting material, explore the latest advancements in associated regulatory guidance to safeguard therapy programs, and present case studies to demonstrate expedited development and manufacture of advanced therapies.

• Understand common manufacturing and quality standards for plasmid DNA and how they align with regulatory guidance
• Determine manufacturing strategies and mitigation plans to streamline ATMP programs
• Explore case study examples

Andrew Frazer

Associate Director, Scientific Solutions, Gene Therapy CDMO Services at Charles River Laboratories

Since graduating with A 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. Andrew now holds a commercial role as Associate Director, Scientific Solutions within Charles River CDMO Services with a focus on the plasmid DNA manufacturing platform and service offering.

Watch now

SPEAKERS

Andrew Frazer

Associate Director, Scientific Solutions, Gene Therapy CDMO Services at Charles River Laboratories

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