- As cell therapy emerges as a commercial reality, shipping and logistics providers have been busy building out new capabilities to support the complex supply chains needed to preserve and transport human cells across the country.
- U.S. approval of Novartis AG's CAR-T therapy Kymriah, the first such treatment OK'd for sale anywhere in the world, will test the commercial viability of delivering the complex and personalized medicine to a broader pool of patients than were involved in clinical trials.
- Scaling up cell therapy will require drugmakers to rapidly freeze and ship fragile cells from dozens of hospital centers to central manufacturing sites and back again — challenges companies like GE Healthcare and Cryoport Inc. hope to help solve.
CAR-T therapy has already pushed the boundaries of what's possible in treating patients with certain types of aggressive blood cancers that are resistant to other treatments.
The remarkable clinical efficacy seen in these patients, who would otherwise have few remaining options, stoked optimism that reprogramming T-cells to target and destroy cancers could transform the standard of care.
That promise has led to heavy investment from biotech and pharma companies eager to become leaders in the still-emerging cell therapy space. Such investment has, in turn, created new market opportunities for companies that specialize in managing complex logistics and shipping networks.
Cryoport, for example, has inked deals with both Novartis, Kite Pharma Inc. and several other cell therapy companies to help with cryopreservation of patient T-cells and what's known as chain-of-identity monitoring.
Since most CAR-T therapies currently in development are made directly from a patient's own cells, companies need to ensure that reprogrammed cells are correctly matched and returned to the original patient. That requires the ability to identify a shipment of patient cells along every step of transport, from hospital through manufacturing and back to the same hospital again.
Challenges like these add new risks and hurdles to the already demanding process of launching a new drug.
Just this week, Cryoport expanded its deal with Kite to cover potential commercialization of Kite's CAR-T therapy axicabtagene ciloleucel, which is currently under review at the Food and Drug Administration.
Others are developing new offerings to help streamline the process. On Tuesday, GE Healthcare announced the commercial availability of a new type of technology that it says can more consistently and reliably thaw frozen cells — once delivered — than current water-bathing practices.
"This technology has the ability to transform the final stage of cell therapy and help advance the industrialization and delivery of these potentially life-saving therapies," said Ger Brophy, general manager of cell therapy at GE Healthcare, in a statement.
Known as VIA Thaw CB1000, the technology is currently limited to research use in laboratory and clinical trial settings. But an explosion in the number of cell therapy studies means demand for such services could be high even years before a company thinks about commercialization.
VIA Thaw CB100 was developed by Asymptote, Ltd, a British company acquired by GE Healthcare earlier this year. The companies unveiled the new tech at the CAR-TCR Summit in Boston, Massachusetts.