There is a clear need and opportunity for NIIMBL to play a role in the development and adoption of technologies related to vector manufacturing. The two most important vector platforms in use in the industry today involve the production of lentiviral vectors (LV) and adeno-associated virus (AAV) vectors. NIIMBL is well-positioned to bring together the appropriate resources to accelerate development of core manufacturing process platforms and essential analytical capabilities for viral vector product and process characterization. Advances in both areas are critical for broad and rapid expansion of the emerging industry of gene-based therapeutics and ultimately the many patients and families who stand to benefit from access to these novel therapies.
Establishment of industrially-relevant NIIMBL platform processes for AAV and LV production could significantly enhance access to and utility of viral vectors for gene-based therapeutic research and development. Such processes could be made 'open' to the NIIMBL and broader community and made available as a standard process for academic and small companies. These processes can be used to develop a shared understanding in discussions with health authorities, support activities of the bespoke gene therapy manufacturing initiative and potentially other consortia, and be used as a platform for innovating new technologies.
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