Innovative Platforms For Improved Viral Vector Development And Scale-Up

By Nick Clarkson and Jin Yin, Oxford Biomedica

The viral vector manufacturing and development space is facing a host of challenges tied to unoptimized platform technologies, poorly understood biology, and shifting market forces, which can make identifying manufacturing capacity that is well-positioned to translate vectors from the clinic to commercial difficult. Those challenges, alongside others specific to developing adeno-associated vectors (AAVs) or lentiviral based vectors (LVs), necessitates deep expertise in productivity improvements, cell line development, chemistry, manufacturing and controls (CMC) strategy, and platform optimization, among other variables.

There exists a broad demand for expertise in AAV and LV manufacturing across the biotherapeutic sector. While nearly everyone in the industry faces challenges with transfection protocols, there are a number of factors unique to LV that can result in increased complexity for developers. For AAV, similar issues related to poor understanding of their biology can often result in low productivity, poor packaging, and difficult scale-up. Companies that contract with development and manufacturing partners that have a limited understanding of vector CMC, as well as unoptimized platforms for commercial production, could find themselves facing manufacturing delays or clinical holds. Combatting this requires a close look at a development and manufacturing partner’s successes in the viral vector space, as well as the innovations they have pursued in vector design, process development, and robust analytics, that have led to improved productivity and high product quality delivered.