To GMP Or Not To GMP? That Is The (Plasmid) Question

By Eric Gudorf, Director of Client Services, and Erika Morris, Director of Business Development, Ajinomoto Bio-Pharma Services

Gene therapies continue to stake their foothold on the clinical trial landscape and comprise the future wave of lifesaving pharmaceuticals; as a result, high-quality plasmids are increasingly in demand as critical raw materials. Since their use in gene therapy production is still relatively new, health authority regulation around plasmids can be limited, and due to the demand and costs associated with their manufacturing, plasmid suppliers often have finite capacity. As drug manufacturers work to secure plasmids for discovery, clinical, and commercial applications, the question looms: how can drug sponsors maintain a manageable budget while procuring a high-quality plasmid supply? Though opting to begin with a GMP-grade plasmid platform – as opposed to GMP-lite – may initially seem the more expensive route, this strategy offers long term benefits. Download the full article to explore the opportunities afforded by choosing the GMP-grade route, including cost savings and consistent raw material supply.