Catalent and GelMEDIX Enter Global Partnership for the Development and Clinical Manufacturing of iPSC-Derived Cell Therapies

GelMEDIX Inc., a biotechnology company developing regenerative therapies to restore vision, and Catalent, Inc., the leader in enabling the development and supply of better treatments for patients worldwide, announced a global partnership to access Catalent’s GMP-induced pluripotent stem cells (iPSC) and Catalent’s cell therapy manufacturing expertise and capabilities to support the development and clinical manufacturing of GelMEDIX’s iPSC-derived cell therapies to treat ocular and retinal diseases.

“Catalent is proud to work with GelMEDIX to support this important clinical program of next‑generation therapies for ocular and retinal diseases,” said David McErlane, Biologics Group President at Catalent. “We look forward to supporting these early development efforts and helping bring transformative treatments to patients.”

“We are excited to partner with Catalent, a leader in developing and manufacturing iPSCs and therapies derived from these cells, to bring our vision-restoring therapies into clinical trials,” said Max Cotler, PhD, Chief Executive Officer, GelMEDIX. “Establishing this partnership early positions us to accelerate our progress toward the clinic for our lead programs focused on restoring vision in patients.”

Under the agreement, GelMEDIX will partner with Catalent for iPSC and cell therapy development and will access Catalent’s proprietary, off-the-shelf, GMP-compliant iPSC lines and Catalent’s GMP iPSC and iPSC-derived cell therapy manufacturing capabilities. Catalent, as a global leader in the development and manufacturing of human iPSCs and iPSC-derived cells, will also support the process development, analytical development, process scale-up and GMP manufacturing of GelMEDIX’s iPSC-derived therapies, from early development through all clinical stages.