Regional manufacturing hubs for autologous therapies are bridging the gap between point-of-care manufacturing and manufacturing those therapies in biopharma companies’ primary facilities.
A model pioneered by Orgenesis, for example, places shipping container-sized cGMP manufacturing facilities called POCenters in locations to serve medical centers within an approximate four-hour radius. The PoCenters contain pre-validated Orgenesis mobile production units or labs (OMPULs), effectively establishing pre-fabricated manufacturing centers for autologous therapies that can begin operations quickly.
Cost reduction is a huge benefit. “Having personal manufacturing locations at a hospital is super convenient from a cycle-time perspective, but the costs are extremely high. That’s the biggest drawback,” Patti Seymour, managing director, BDO, tells GEN.
Additionally, “Regional manufacturing facilities for autologous therapies don’t need as many full-time equivalents or as much equipment,” to serve an area as point-of-care manufacturing facilities need. They also offer the efficiencies associated with high-throughput, improve quality control, and streamline logistical issues.
The downside of removing manufacturing from point of care to a regional hub, she says, is that “the vein-to-vein timeline increases.” Positioning autologous manufacturing facilities within a few hours’ drive, where they can serve multiple hospitals easily, eases that concern.
In contrast, point-of-care manufacturing facilities can deliver therapeutics to patients quickly, but they tend to experience lengthy downtimes between uses that lengthen the time needed to recoup a return on the investment. Later, when those facilities are used to produce therapeutics for clinical trials, product testing and manufacturing must be harmonized, adding layers of complexity and costs for study coordinators.
At BDO, Seymour says, “We’ve modeled various scenarios comparing autologous manufacturing centers at a hospital, at a regional hub, and at one big location, weighing the pros and cons of each in terms of time versus cost. The regional hubs seem to be in the Goldilocks zone…as a reasonable intermediate.”
To be successful, regional manufacturing sites must be situated near the patients and near a trained workforce. “Right now, the biggest concerns are getting qualified people to run these operations,” Seymour says.
Siting such facilities, therefore, entails selecting areas with multiple large teaching hospitals, such as Boston and a handful of other key metropolitan areas. Other parts of the country, where the density of leading medical centers and employees trained in biomanufacturing may be scarce, regional hubs may not make as much sense.
Overall, however, Seymour says, regional autologous manufacturing hubs, “are a viable model.”