Those following the regenerative medicine (RM) industry are likely in-tune with a rapidly evolving market, on the periphery, that is shaping up to provide a very attractive value proposition to patients, industry, and investors alike.
The health care industry is undergoing a paradigm shift: Big Pharma has historically spread its efforts across palliative and substitutive care, and to a certain degree preventative care; however, a fourth pillar of care is rising – curative care. The evolution of cell-based immunotherapies for the treatment of cancer and other indications is well underway, and it is generating excitement around the globe.
“I find out what the world needs, and then I proceed to invent it”. – Thomas Edison
Dr. Dolores Baksh, the new Innovation Leader for Cell Therapy at GE Healthcare, shared this quote at the end of her presentation at the recent Till & McCulloch Meetings in Ottawa (October 27-29). It encapsulates GEs approach to commercialization and underlines why the company opened a £3M facility for the study of cell sciences in Cardiff, Wales, in December 2012.
Could cell therapy be a trillion dollar industry by 2025? GE thinks so, and given the incredible speed at which the industry is growing, one could be convinced. With a great deal of foresight, and a recognition of the cell manufacturing ecosystem required for support, GE is striving to position itself as the go-to provider of streamlined, automated manufacturing systems for the generation of immunotherapy doses – by the thousands. However, there is a litany of cost considerations involved in the development of cell-based immunotherapies. So, companies like GE and Novartis, another giant that has entered the space, are giving serious thought to new business models and cost structures, and how infrastructure will most optimally be built.
Dr. Baksh highlighted that cost structure is heavily dependent on whether a company is taking an allogeneic, bulk approach, or a patient-specific approach. In the case of allogeneic therapies, there are high capital expenditure costs upfront for the construction of cell banks and production facilities. Autologous therapies will not have the same demands in terms of volume, but will come with unique costs such as the logistics of moving patient-specific samples between sites, chain of custody concerns, and rigorous testing. Expansion, particularly in the case of allogeneic therapies, is a considerable cost-driver due to the cost of media, reagents, and serum.
There are risks inherent to each approach as well. When dealing with patient-specific samples there is very little room for error. The immunotherapy company essentially has one shot on goal. Allogeneic therapies will be produced in batches of hundreds, if not thousands, of doses. A failed batch can have a significant impact on revenue.
Factory-scale and manufacturing floor plans are other aspects of cell therapy commercialization that GE is currently addressing. For patient-specific therapies, manufacturing thousands of doses on an annual basis could require as many as 150 personalized processes occurring in tandem. One can appreciate the complexity of achieving this feat.
There will be a manufacturing paradigm shift that accompanies the industrialization of the cell therapy industry. Historically, GMP manufacturing facilities have processed handfuls of samples in individual suites. The advent of closed systems will allow for the deconstruction of this model. GE envisions a facility with suites that compartmentalize unit operations, while allowing for automation between all rooms.
Perhaps one of the most important messages Dr. Baksh sent the cell therapy community is to design-in the most significant cost drivers early in the clinical program, as the cost- and regulatory-burdens are much higher at later stages of development. Processes should be locked in by the Phase 3 stage.
Eytan Abraham, Head of Cell Therapy Research &Technology at Lonza, echoed this sentiment in a later discussion he held focused on the challenges of commercializing cell therapies. More on this in a subsequent blog.