Pharmaceutical Grade Large-Scale Plasmid DNA Manufacturing Process

For pharmaceutical applications of plasmid DNA, either direct or indirect, certain quality standards are required. Whereas for direct gene transfer into human “Good Manufacturing Practice” (GMP) grade is mandatory, for GMP production of, e.g., viral vectors (AAV, etc.) the plasmid DNA used needs not necessarily be produced under GMP.
Source: Springer protocols feed by Immunology - Category: Allergy & Immunology Source Type: news