Plasmids are a critical raw material for emerging modalities, whether it’s AAV, lentivirus, or any other cell and gene therapy. To meet demand for this material, the market has exploded with plasmid manufacturers in recent years. However, not all of these providers offer GMP-based services.
Many of the manufacturers entering the market may start with phase-appropriate plasmid DNA (pDNA) production and then add GMP manufacturing when it is needed. Developing a GMP production and release system while running a plasmid business does not allow for focused, GMP oversight from the beginning of a project.
Leveraging the consistent raw material supply and proven quality systems of an experienced, GMP-based plasmid manufacturer ensures high-quality production and a cost-effective process as you aim to bring your novel therapeutic to market.