The excitement around the CAR-T therapies was palatable at this conference. More entrants to the field are coming every month and more diseases are being considered targets for immunotherapies. First liquid tumors, now solid tumors, are being successfully treated by modulating patients’ immune systems with genetically modified cells. The number of clinical trials in both Europe and the U.S. has skyrocketed, and the initial results reported are impressive.
However, we are in the early days of CAR-T cell production. One presenter illustrated this basic manufacturing process in need of improvement by comparing today’s production with Ford’s Model-T manual assembly line.
During a panel with representatives from Kite Pharma, Adaptimmune, Cellectis and Autolus, the outlook was unanimous: the manufacturing of T-cells will be one of the most important elements of their organizations’ successes. They also agreed the current processes need to be simplified, automated, and closed. The discussion encompassed the pros and cons of centralized versus decentralized models of manufacturing; however, at least for the time being, the panel participants are opting for central manufacturing for two main reasons: control of product consistency and release testing. Most speakers discussed how they have invested, or are in the process of investing, in building their own manufacturing facilities, including Kite Pharma who has built a facility to treat 4,000 to 5,000 patients annually.
Other speakers during the conference believe a more decentralized model at the point of treatment is the future for CAR-T therapies. One thing all speakers agreed is that they “have to plan for success now” as it pertains to production of CAR-T therapies as the industry is preparing to set a new standard for best practice in oncology.
As more clinical trials are launched, and some therapies are nearing commercial approval, the imperative to deliver life-saving treatments to as many patients as quickly as possible is essential from an ethical and business standpoint.
From Invetech’s experience in working with clients to close cell and advanced therapy manufacturing processes, the priorities are in sync. In fact, correctly timing investment in technology to manufacture a consistent product ensures the reduction of risk that administering a variable product or therapy influences clinical trial results. We have also seen that access to capital is more readily available and is less expensive to negotiate when companies can prove their plans for commercial production are understood and achievable. Finally, resources in the form of personnel costs, number and types of equipment, facility size and clean room grade requirements are drastically reduced, so capital is conserved as the technological solutions are planned and implemented.