BRIEFING

 〈1040〉 Quality Considerations of Plasmid DNA as a Starting Material for Cell and Gene Therapies. The Biologics Monographs 5—Advanced Therapies Expert Committee is proposing the following new general chapter. The goal of this general chapter is to describe considerations for the manufacture and release of plasmids for use as starting materials in the manufacture of cell and gene therapy drug products. Because plasmid DNA suppliers have been taking different approaches to manufacturing and applying different specifications, this general chapter was developed to assist manufacturers of gene therapy drug substances and drug products in building a control strategy for the plasmid DNA used as a starting material.

 (BIO5: R. Potts)

 Correspondence Number—C320084