Fueling The Genetic Revolution With cGMP Manufacturing And Training

By Michael Paglia, COO, ElevateBio BaseCamp, and Shannon Eaker, Cell and Gene Therapy FastTrak™ Leader, Cytiva

Cell and gene therapies have the potential to represent a larger percentage of biologics, but their unique characteristics and uses do pose challenges. For instance, cells for personalized CAR-T therapies are taken from sick patients and manipulated to fight their cancer. There’s variability between donors, cells must be handled with care to ensure they remain viable, and they must be delivered to the correct recipient at the right time. In another example, viral vectors that carry genetic information for CGTs are large and may be unstable. They may also require a biosafety level 2 (BSL-2) classification. Traditional BSL-2 facilities are expensive to build and operate because of the HVAC and air handling needed, and they can take several years to build. And for emerging biotech companies, time and money are in particularly short supply as they race to their next milestone.

The high demand for cell and gene therapies and the materials to research, develop, and manufacture them led to a significant “capacity crunch” across the industry. Without a surge in capacity – or innovative technological solutions – this shortage will only continue, eventually slowing R&D in this space as well as market entry for CGT products that often have an accelerated regulatory path to approval. Even companies that have secured a spot face the ongoing concern of maintaining their intellectual property, not to mention potential failures during process transfers. The challenge of securing qualified staff is another ongoing issue that will plague the success of CGTs.

ElevateBio, a cell and gene therapy technology company focused on accelerating the development of life-saving therapies, has an experienced team that understands the wide range of challenges CGTs present. Download the full article to learn more about how, through its collaboration with Cytiva, ElevateBio has established a toolbox of solutions to serve as an engine for innovation and resolution, ultimately driving the successful commercialization of CGTs for the patients who need them.