CHA Biotech said Tuesday that it has agreed to manufacture SCM Lifescience’s cell therapies using bone marrow.
Under the accord, CHA Biotech will make its partner’s acute pancreatitis therapy, SCM-AGH and SCM-CGH, for chronic graft versus host disease through subsidiary CHA BioLab.
Last October, the U.S. Food and Drug Administration granted orphan drug designation status to both drug candidates, which are in phase 2 clinical trials for development.
SCM Lifescience decided to team up with CHA Biotech before expanding its Good Manufacturing Practice (GMP) facility to boost synergistic effect between the two companies and present a collaborative model strengthening global competitiveness.
The two partners believe the two drugs to receive conditional use authorization from the regulators after completing the phase 2 studies.
CHA Biotech has been a global leader in the contracted development and manufacture of cell gene therapy. Its affiliate CHA BioLab won permission to make advanced biopharmaceutical products last December, bolstering the group’s CDMO business.
“Although we have a GMP-certified facility licensed to manufacture advanced biopharmaceuticals, we hope to accelerate commercialization after receiving conditional approval by completing the studies with CHA Biotech,” SCM Lifescience CEO Rhee Byung-gun said. “Our partner will be able to produce quality products based on its know-how in developing stem cell treatments and operating facilities with GMP certification.”
CHA Biotech CEO Oh Sang-hoon said, “CHA Biotech plans to expand the strategic cooperation with SCM Lifescience from clinical studies to commercialization and support the development of cell therapy products promoted by our partner with competencies and collaboration.”
In February, CHA Biotech began constructing a cGMP facility in Texas through its U.S. subsidiary, Matica Biotechnology. The company will accumulate CDMO experiences through its U.S. offshoot and plans to advance into the CDMO market for cell gene therapy in the U.S., Europe and Asia by linking it to a 16-acre GMP plant to be completed in Pangyo, south of Seoul, in 2024.