Cell therapy manufacturing is becoming of growing importance as more and more cell therapeutics make their way through clinical trials. 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.
Cell Therapy Manufacturing CDMOs
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.
Autologous Cell Therapy 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.
Today, 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.
Increases in cell therapy clinical trials have been a major factor driving progress with cell therapy manufacturing processes. 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.”
Cell and Gene Therapy Manufacturing
For cell and gene therapy manufacturing, benefits of partnering with a CDMO include scalability, speed to market, access to technical expertise without overhead costs, and cost efficiencies. As the demand for these services have grown on a global basis, dozens of market competitors have moved into cell therapy manufacturing services.
Important market leaders for cell therapy manufacturing now include:
- Minaris Regenerative Medicine
- WuXi Advanced Therapies
- Nikon CeLL innovation Co., Ltd. (“NCLi”)
- Roslin Cell Therapies
- And nearly a hundred more
In the gene therapy manufacturing space, companies are also rapidly populating. For example, two biotech company (Vectalys and FlashCell) merged to form Flash Therapeutics, a developer of non-integrating lentiviral delivered RNA treatments. In addition to developing its own therapies, FlashCell offers development and manufacturing support to companies worldwide pursuing lentiviral delivered therapies.
As a result of regenerative medicine trials increasing in number, there will be growing opportunities for cell and gene therapy manufacturing services in 2019 and beyond. Today there are 1,050+ regenerative medicine companies competing on a global basis, which is creating a surging need for cell and gene therapy manufacturing services.
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