GelMEDIX Inc., a biotechnology company developing regenerative therapies to restore vision, and Catalent Inc., a global contract development and manufacturing organization (CDMO), have partnered to utilize Catalent’s GMP-induced pluripotent stem cells (iPSC) and 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.

Under the agreement, GelMEDIX 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 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.

“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, CEO, GelMEDIX. “Establishing this partnership early positions us to accelerate our progress toward the clinic for our lead programs focused on restoring vision in patients.”