- Catalent and S.Biomedics have entered a strategic partnership to support development and GMP manufacturing of TED-A9, an allogeneic stem-cell–derived therapy for Parkinson’s disease.
- Catalent will provide cell therapy development, analytical services, and manufacturing support for the program’s pivotal U.S. clinical study.
Catalent has announced a strategic partnership with S.Biomedics to support the development and manufacturing of TED-A9, an allogeneic pluripotent stem-cell-derived ventral midbrain–specific dopaminergic precursor cell therapy for the treatment of Parkinson’s disease.
The collaboration is designed to establish a scalable, GMP-ready manufacturing foundation to support a planned pivotal U.S. clinical study. TED-A9 is developed using S.Biomedics’ proprietary targeted embryonic stem cell differentiation (TED) platform and forms part of the company’s broader pipeline of stem-cell-based regenerative therapies.
Under the agreement, Catalent will leverage its global network and expertise in cell therapy development, analytical services, and GMP manufacturing. The company stated that its integrated platforms and experience in induced pluripotent stem cell (iPSC) and embryonic stem cell (ESC) technologies will support the program from development through clinical and potential commercial stages.
“We are pleased to partner with Catalent, a global leader in cell therapy CDMO services, as we establish a scalable, GMP-ready manufacturing foundation to support pivotal development and enable a potential path toward future commercialization.”
Tony Kang, chief executive officer of S.Biomedics
The partnership aligns with Catalent’s strategy to support innovators in advancing cell therapies toward commercialization, while enabling S.Biomedics to progress TED-A9 through pivotal clinical development with manufacturing capabilities designed for future scale-up.
