Gene therapy is one of the most promising developments in medicine. It has the potential to treat many diseases by using a gene-modifying technology to repair, replace or correct genetic damage in the body. Last year was an important year for advancing gene therapy with two pioneering Chimeric Antigen Receptor T Cell (CAR T) cell therapies for cancer approved in the US: Novartis’ Kymriah® and Kite/Gilead’s Yescarta® and Spark’s Luxturna® was approved to correct a retinal disease.
Gene Therapy Manufacturing
Viral vector systems are by far the most widely used methods to deliver therapeutic gene products because of their high rates of infectivity. The most commonly used viral vector systems are adeno associated viruses, lentiviruses, and adenoviruses.. However, a major hurdle for gene therapy commercialization is meeting the large demand for viral vectors that commercialization requires.
Large scale, optimized virus production is critical to success. Scale is one of the biggest considerations when designing the manufacturing process. Once product demand is determined, the process must be capable of expanding to meet clinical and ultimately commercial manufacturing requirements.
Previously, there had been little development of technologies designed specifically for gene therapy manufacturing and the result was that processes were cobbled together using technologies designed for monoclonal antibody production or other applications. Recently that has changed and new manufacturing technologies are being designed to provide solutions for gene therapy manufacturing. As this happens, the opportunity for optimized, end-to-end solutions are now a reality.
Large Scale Adenovirus Manufacturing
I recently was able to speak with Clive Glover, PhD, Senior Marketing Manager, Cell and Gene Therapy, Pall Biotech about gene therapy manufacturing solutions at large scale. Clive is moderating a webinar on end-to-end large scale adenovirus manufacturing and provided me a sneak peek. In the webinar, Pall Biotech will present an end user case study that illustrates the challenges and solutions in scaling upstream and downstream processes. Based on the case study, the webinar will share how they were able to accelerate time to market, design a scalable process, and reduce downstream processing time from 3-4 days to 1 day.
To hear our interview about end-to-end large scale adenovirus manufacturing, please listen below.
To learn more, you can register for the webinar at An End-to-End Solution for Large Scale Adenovirus Manufacturing
Wednesday November 7th – 8:00 a.m. PST/11:00 a.m. EST
Tuesday November 13th – 8:00 a.m. GMT / 9:00 a.m. CET / 1:30 p.m. IST / 5:00 p.m. JST