12.01.22 -- Streamline The Development Of Plasmid And Viral Vectors

The keys to success are establishing appropriate strategies and 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.

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 complexities impacting their scale-up. Ensuring optimal yield for engineered viral vectors early in a process is crucial to ensuring their eventual commercial viability and broader patient accessibility.

Access to plasmids is a significant stumbling block; however, instability in manufacturing, and issues identified post-sequencing, are perhaps bigger concerns than capacity, but both are important considerations for companies looking to streamline their development efforts. Working closely with a CDMO that performs in-house plasmid production affords companies the opportunity to collaborate, optimize processes, and create efficiencies.