Regulatory & supply chain implications for plasmids as critical starting materials in the manufacture of viral vector gene therapy products

Plasmid DNA is actively being used as starting material/intermediates, drug substance, and/or drug product in the manufacture of several therapeutics including DNA vaccines, viral-vector and non-viral-vector gene therapies, and mRNA vaccines. Since plasmids have a large range of uses, there have been various plasmid guidelines released from the different agencies. Specifically for gene therapy, recent guidelines have tried to provide clearer guidance, however there is still ambiguity around quality requirements. For example, the specifications for the release of plasmids from a plasmid manufacturer and the facility requirements for accepting these plasmids for use in viral vector manufacturing are not always aligned and can cause disconnect in the supply chain. For a sponsor managing plasmid manufacturing for use as starting material in viral vector manufacturing, it is important to be aware of these differences in requirements ahead of time. The current manuscript highlights these regulatory differences and calls out the importance for a sponsor to build a robust supply chain between the plasmid manufacturer and the viral vector manufacturer well in advance to minimize bottlenecks due to quality requirements and timelines.

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