〈1040〉 Quality Considerations of Plasmid DNA as a Starting Material for Cell and Gene
Therapies Including RNA Products
1. INTRODUCTION
Plasmids are double-stranded, circular DNA biological molecules that can be used as starting materials during the manufacture of cell and gene therapy (CGT) products, including linearization and subsequent in vitro transcription (IVT) for mRNA drug production. The goal of this general chapter is to describe considerations for the manufacture and release of plasmids for use as starting materials in the production of CGT products.