By Kristin Heller, Plasmid Core Manager, and Andy Moreo, Head of Process Development, Plasmid and Viral Vector Core Facilities, Andelyn Biosciences
The proliferation of targeted cell and gene therapies as first-line treatments for many rare and complex disease states has spurred demand for materials that meet the downstream needs for these applications. Plasmid DNA, purified from bacteria, serves several important roles in the biologics and cell and gene therapy spaces – from transfection to sequencing, cloning to PCR, plasmids have a ranging utility that has helped drive personalized medicine innovations.
Securing the right plasmid for a given application can be a complex endeavor. Between the wide variance that can occur in their development to the shifting regulatory standards that define their production, plasmids require the right expertise and experience to optimize their development for varying manufacturing paradigms.
Choosing the right plasmid can help prevent costly delays in the development lifecycle. Core to this is selecting a supplier with the quality assurance protocols and Good Manufacturing Practices (GMPs) in place to facilitate optimized plasmid production.