PDA Releases Points to Consider Number 11 for Plasmids and Vectors in ATMP Production 18 February, 2025

PDA has released Points to Consider No. 11 Development, Classification, Manufacture, Control, and Testing of Plasmids and Vectors Used in ATMP Production on its bookstore and membership technical report portal.

In Advanced Therapy Medicinal Product (ATMP) production, plasmids and vectors play a crucial role in the development of gene therapies, cell therapies, and tissue-engineered products. Both are fundamental components in the manufacturing of gene therapies, CAR-T therapies, and RNA-based treatments. The Report is focused on the use of viral vectors for delivery of a therapeutic gene, both in vivo and for ex vivo modification within the overall classification of ATMPs.

"PDA's Points to Consider documents help the industry by providing clear information and strategies to address ATMP areas where current regulations and practices are unclear," said Josh Eaton, PDA Sr. Director of Scientific and Regulatory Affairs.

The Report clarifies plasmid and viral vector categorization and control, quality by design concepts, control strategies, filtration, comparability, platform technologies and potency assays. Eaton adds, "We are grateful for the hard work and dedication of the authoring team in providing valuable guidance on navigating the complex and varied regulatory and quality considerations involved in manufacturing ATMPs using viral vectors. Special thanks go to the co-leads, Monica Commerford, PhD of Autolus and Qiang Qin, PhD of Novartis, for helping drive this effort to completion."

The report is presented in a convenient, easy-to-use, question-and-answer format, citing specific problems with corresponding recommendations to assist professionals formulate strategies to address the issues.

PDA PTC No. 11 is available at PDA's Bookstore: https://www.pda.org/bookstore/product-detail/8228-points-to-consider-no-11