Catalent, GelMEDIX partner on iPSC therapy manufacturing

Biotechnology company GelMEDIX has entered a global partnership with Catalent, a contract development and manufacturing organization (CDMO), to support the development and clinical manufacturing of induced pluripotent stem cell (iPSC)-derived therapies aimed at treating ocular and retinal diseases.

Under the agreement, GelMEDIX will access Catalent’s proprietary, off-the-shelf GMP-compliant iPSC lines along with the company’s cell therapy development and manufacturing capabilities. Catalent will provide process development, analytical development, scale-up, and GMP manufacturing support for GelMEDIX’s iPSC-derived therapies from early development through clinical stages, according to the announcement.

The collaboration expands Catalent’s recent work supporting stem cell-based therapies. Earlier this year, the company partnered with S.Biomedics to support the development and manufacture of TED-A9, a pluripotent stem-cell-derived dopaminergic precursor therapy under development for Parkinson’s disease.

The company has also entered a nonexclusive license agreement with SmartCella to use its GMP-compliant iPSC platform for regenerative therapies targeting cardiac disease and Parkinson’s disease. Catalent said these collaborations build on its global cell therapy network and manufacturing capabilities, supporting the development and potential commercialization of cell-based therapies.

At the same time, Catalent recently decided to close a cell therapy center in Belgium amid reported drop in production, joining other CDMOs who have decided to scale back cell and gene therapy facilities or completely exit the market due to overcapacity and weak demand. While recent setbacks have hit its cell and gene therapy business, Catalent says fundamentals are strong.