The Benefits Of Streamlining And Standardizing Plasmid DNA For Cell And Gene Therapies

By Meagan Gelinske, Director, DNA Product Technology, Aldevron

Prompted by the rapid exponential growth in the cell and gene therapy (C&GT) space, manufacturing standardization has received increased focus in the last several years. The resulting need for improved access to high-quality raw materials, including plasmid DNA, has made standardization integral to streamlining the development process for this biologic product category.

Standard sets of helper and packaging plasmid constructs are generally used for viral vector production for both adeno-associated virus (AAV) and lentiviral C&GT applications. Within each set, all but one construct – the program-specific plasmid containing the gene of interest, or transgene – are potential candidates for standardization. Establishing standardized plasmids conferring helper and packaging functions for viral vector production provides significant time and cost reductions for researchers, expediting time to market and de-risking specialized, transformative therapeutic development.

Researchers can streamline their upfront development while minimizing supply chain disruption throughout their program’s lifecycle by partnering with a contract development and manufacturing organization (CDMO) offering standardized plasmid options for viral vector production.

Explore how to optimize therapeutic development through standardized materials and one company’s plasmid solutions.