Dive Brief:
- Privately-held DiscGenics has hooked up with CCRM and GE Healthcare in order to scale-up and streamline the manufacturing of the regenerative medicine company's off-the-shelf injectable cell therapy. The work will be carried out at the Centre for Advanced Therapeutic Cell Technologies.
- CCRM and GE Healthcare are working on process, assay and media development to improve production, which begins with the isolation of cells from donated intervertebral discs and results in progenitor cells that can be introduced into the degenerated disk.
- Degenerative disk disease, one of the most common causes of chronic low back pain, affects around 25 million people across the U.S. Treatments range from physical therapy, through pain medication to surgery.
Dive Insight:
DiscGenics' homologous allogeneic injectable cell therapy has just moved into Phase 1/2 in degenerative disk disease and this has triggered the need for the manufacturing deal.
"In preparation for commercialization, we are committed to optimizing our in-house manufacturing capabilities and ensuring our processes comply with cGMP regulations," Flagg Flanagan, CEO and chair for DiscGenics said in a statement. "The CCRM and GE Healthcare team is playing an integral role in these manufacturing initiatives by providing invaluable scale-up know-how and process development expertise, as well as allowing us to evaluate manufacturing equipment options."
Even though DiscGenics' therapy is still in early stages, the company realizes the value of developing a manufacturing protocol early in the process.
"Manufacturers need to be able to duplicate product attributes at larger scale as they progress through clinical trials and into commercial phases, so it’s critical to develop scaled up manufacturing processes early on," said Phil Vanek, GM of cell and gene therapy strategy at GE Healthcare Life Sciences.
Cell therapies, particularly those where patients' cells are removed, modified and returned, will require specialist manufacturing and supply chains. While some cell therapy developers are expanding in house, others are reaching out to specialists.
In March this year, Daiichi Sankyo teamed up with Hitachi Chemical for the manufacture of clinical candidates, using PCT, Hitachi's global cell therapy manufacturing and development service platform. And in April, Autolos inked a supply deal with Miltenyi Biotech to access the German company's automated cell-processing platform.