A Platform Standard For Viral Vector Manufacturing And Commercialization

By Eva Fong, Principal Scientist and Jessica Hilmoe, Technical Leads Manager, MilliporeSigma

Interest in cell and gene therapies is continuing to grow as regulatory approvals increase and the clinical pipeline expands. As these therapeutics moves toward indications with larger patient populations, the pressure to improve manufacturing efficiency and robustness is rising.

One important component for cell and gene therapy manufacturing is the large-scale production of viral vectors. Specifically, vectors need to be produced efficiently and meet set quality attributes. To meet these goals, platform technologies must be developed and implemented to support the rigors of commercial manufacturing.

We recently launched the VirusExpress® Lentiviral Production Platform to produce industry-leading vector harvest titers while improving speed and commercial readiness for manufacturers. In addition, we are currently developing an equivalent program offering of an upstream platform and templated process to achieve the same benefits for Adeno-Associated Viral (AAV) gene therapies. Key features of our templated process approach include process validation and continued process verification, we discuss in more detail here.