Towards a scalable and cost-efficient process
The viral vector market is highly active, and the interest in production technologies is driven by recent approvals in cell and gene therapy. Here we share insights around the challenges in viral vector manufacturing. The focus is on helping readers to obtain a scalable and cost-efficient process suitable for GMP manufacturing environments.
Viral vector capacity crunch
Demand for viral vector production is high. The main driver is the large pipeline in different clinical stages and scales. In 2018 there were more than 1000 clinical trials for cell and gene therapies, many of which use viral vectors. Adenoviruses and retroviruses, including lentivirus, are frequently used. Adeno-associated virus has grown rapidly the last few years, mostly in the gene therapy area. Also, development of oncolytic virus therapies and vaccines are further driving demand.
Compared with use in cell therapy, high-dose systemic administration for gene therapy requires more virus bulk. This means higher demands on process efficiency and production scale. Contract manufacturers are struggling to keep up with the demand for viral vectors. There is an urgent need to increase capacity for viral vector production, preferably using platform technologies.