One of the major issues with moving cell therapy products from “bench to bedside” has been manufacturing bottlenecks. The heterogeneous nature of cell therapy products has introduced manufacturing complexity and regulatory concerns, as well as scale-up complexities that are not present within traditional pharmaceutical manufacturing.
While these realities may sound like negative factors for the industry, the reality is quite the opposite. For cell therapy CDMOs, these factors create pressures for cell therapy companies to seek third-party partners who possess technical, manufacturing, and regulatory expertise in cell therapy development and manufacturing.
Furthermore, much of cell therapy manufacturing now involves patient-specific cell therapies, where cells for an individual patient are processed one batch at a time. Ten years ago, it was a common belief that making separate batches of a therapy for each patient would never fit the “big pharma” business model. Logically, allogeneic therapies would better align with the pharmaceutical model, because universal cell populations could be prepared in advance to later be prescribed to patients in need, much like drug compounds have been administered for decades.
Nonetheless, clinical data in support of patient-specific therapy has been compelling, so the pressure is on cell therapy CDMOs to make these therapies on a larger scale. It is now understood that both autologous and allogeneic cell therapies will contribute important therapeutic solutions. There are opportunities for developing and manufacturing autologous and allogeneic cell therapy products, which vary greatly in their manufacturing requirements, routes for patient administration, and cost structures.
Additionally, increases in cell therapy clinical trials are driving progress with cell therapy manufacturing technologies. As stated by Dr. Jon Rowley, Founder and CTO of RoosterBio, “To date there has been substantial cell therapy product innovation. It is now time for the industry to focus on cell therapy manufacturing process innovation.”
Finally, new market entrants have gradually been moving into the cell therapy CDMO field. Key market players include WuXi PharmaTech (and its subsidiary WuXi AppTec), Lonza Group (acquired PharmaCell), Hitachi Chemical Advanced Therapeutics Solutions (acquired PCT), MasTHerCell, Nikon CeLL innovation Co., Ltd. (“NCLi”), Roslin Cell Therapies, and many more.
As a result of these market forces there will be growing opportunities for cell therapy CDMOs in 2017 and beyond.