09.29.22 -- Accessing In-House Plasmid Production To Secure Supply Chains

Access to plasmid is a significant stumbling block in downstream biopharmaceutical manufacturing; instability in manufacturing, as well as issues identified post-sequencing, are perhaps bigger factors in this problem than capacity, but each are important considerations for companies looking to streamline their development efforts.

The ability of viral vectors to target specific cells has made them one of the most promising treatment modalities to emerge in recent years, but the specificity enabled by this tropism has created scale-up complexities. Ensuring optimal yield for engineered viral vectors is crucial to ensuring their eventual commercial viability.

Choosing the right plasmid can help prevent costly delays in the development life cycle. Core to this is selecting a supplier with the quality assurance protocols and good manufacturing practices (GMPs) in place to facilitate optimized plasmid production.

The key to success is establishing appropriate strategies, beginning with fundamental testing, expecting additional regulatory requests, being prepared for assay variability, recognizing the limits of current understanding, and ensuring that comparability studies will be possible by retaining material from preclinical batch runs and stability studies.