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


As gene therapies continue to stake their foothold on the clinical trial landscape and comprise the future wave of lifesaving pharmaceuticals, high-quality GMP-grade 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, GMP-grade plasmid suppliers often have finite capacity. As drug manufacturers work to secure plasmids for discovery, clinical, and commercial applications, the question looms: how can you 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, including cost savings and a consistent raw material supply. Ultimately, it is crucial to partner with an experienced plasmid manufacturer with the capability to produce GMP grade plasmids that will mitigate risk. As you navigate obstacles together, ideally each party communicates their needs to find solutions and reach a shared goal. Even though the project belongs to your team, the right CDMO should be equally invested in the flourishing of your drug program and will provide high-quality plasmids to help ensure the success of your drug product.