CAMBRIDGE, Mass. — GelMEDIX Inc., a biotechnology company focused on regenerative treatments designed to restore vision, has entered into a global collaboration with Catalent, Inc. to support the development and clinical manufacturing of stem cell–derived therapies for ocular and retinal diseases.
The partnership will give GelMEDIX access to Catalent’s good manufacturing practice (GMP)-compliant induced pluripotent stem cell (iPSC) lines and the company’s capabilities in cell therapy development and manufacturing. The companies said the collaboration is intended to help advance GelMEDIX’s pipeline of iPSC-derived therapies toward human clinical trials.
“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 of 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, Catalent will assist with several stages of development, including process and analytical development, manufacturing scale-up, and GMP production of the therapies. The company will support GelMEDIX programs from early development through clinical-stage manufacturing.
Catalent executives said the collaboration reflects growing industry efforts to advance next-generation regenerative medicines aimed at treating degenerative eye conditions.
“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.”
