Lentiviral vector process development and GMP manufacturing

The number of exciting and high-profile products based on gene and cell therapy has increased significantly over the past few years. Consequently, advanced therapeutics now attract significant interest from the wider biotech/Pharma and investment communities. For over 25 years, Oxford Biomedica (OXB) has been a pioneer in the development of products based on lentiviral vectors, with the company being responsible for several firsts in clinical studies based on these vectors. OXB has used this broad CMC, clinical and regulatory experience and know-how to facilitate development of a scalable, serum-free suspension manufacturing process for the company’s CDMO partners.

As the industry matures, technologies have struggled to keep pace with the expansion of therapies from ultra-rare to larger indications. This has driven the need for further innovation in vector production platforms the success of the industry hinges on. OXB has adopted a number of strategies to develop the next generation manufacturing processes yielding higher quantities of vector with suitable product quality attributes and acceptable cost of goods in order to maximise capacity and advance development of a diverse product portfolio in therapeutic areas which currently present significant challenges. These include process intensification through continuous processing, novel methods for vector purification, a transition towards producer cell lines. These innovative technologies provide opportunities to deliver sufficient vector quantities suitable for commercial manufacture for all indications