Points to Consider No. 11: Development, Classification, Manufacture, Control, and Testing of Plasmids and Vectors Used in ATMP Production​

This Points to Consider document 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. The topics addressed are diverse and include plasmid and viral vector categorization and control, quality by design, control strategies, filtration, comparability, platform technologies and potency assays. The topics are presented in a question-and-answer format, presenting a specific problem statement and an accompanying recommendation to assist the reader in formulating a strategy to address the topic.