The Backbone Of Biologics: Enhancing Development And Mitigating Challenges With Plasmid DNA

Plasmids, essential in biologics manufacturing, pose challenges in their development and scale-up due to difficulties integrating and optimizing them with the appropriate cell lines during process development. Aldevron's NanoplasmidTM vector, a next-generation solution, addresses these issues, enhancing safety and performance for cell and gene-based therapy applications.

Transitioning to manufacturing presents further challenges in producing the required volume, concentration, and quality of plasmids. Moreover, producing GMP-grade plasmids at scale is problematic due to strict FDA regulations prohibiting the culturing of E. coli cells in facilities used for eukaryotic cell lines. To overcome these challenges, companies can collaborate with Contract Development and Manufacturing Organizations (CDMOs) with the necessary resources and expertise.