Aseptic filling technology for allogeneic cell therapy

CEFO Co., Ltd. (located in Seoul and Kwangmyung, South Korea) has a vision of regenerative medicine using advanced cell and tissue technology. They use the AT-Closed Vial® technology and Crystal M1 Filling Station to support their Phase I and II clinical trials and enable further scalability for their off-the-shelf cell therapy product.

The therapy

As part of the pipeline, CEFO Co. develops musculoskeletal cell therapy, targeting the osteonecrosis of the femoral head, a debilitating disease of the highest part of the thigh bone. This therapy is based on the allogeneic umbilical cord-derived osteoblastic cells, making it high-yield (more than 10,000 vials from a single donor) and available off-the-shelf.

Moreover, this cell therapy is injectable and, as the patient receive living cells, before it, the product shall be frozen (cryostored). Entering into the Phase I of the clinical trials, the team of CEFO Co. was looking for a GMP-compliant aseptic fill & finish technology that would allow further scaling-up, and satisfy the needs in low-temperature storage and user-friendly administration.

Website

Project Summary

Established in 2011, CEFO Co., which stands for “Cell Engineering For Origin” develops targeted cell therapy to cure intractable human diseases.

With a GMP-compliant AT-Closed Vial® process and cryogenic packaging system in place, CEFO has established a robust manufacturing foundation for the reliable clinical supply and future scale-up of CF-M801, which is an allogenic osteoblastic cell therapy for osteonecrosis of the femoral head (ONFH). The system enables consistent filling and secure container closure while supporting product integrity throughout cryogenic storage and transportation.

CF-M801 has successfully completed a Phase 1 clinical trial in ONFH and is currently undergoing a Phase 2 clinical trial in South Korea. It has received Orphan Drug Designation in both South Korea and the EU, and CEFO is also advancing its clinical and regulatory development in Japan. The platform is being expanded into additional musculoskeletal indications, including fragility hip fracture and spinal fusion.

Building on these milestones, CEFO is preparing for European clinical development through collaborations in Sweden and engagement with the European cell and gene therapy ecosystem. What began as a need for reliable AT-Closed Vial® solution has become part of a scalable manufacturing foundation supporting CEFO’s global development of off-the-shelf allogeneic cell therapies.

Hyun Sook Park

CEO

"The AT-Closed Vial® is the only solution that meets our needs. This technology enables us to enter the final stage of our project. Thanks to the fill & finish solution by Aseptic Technologies, CF-M801 (cell therapy for bone regeneration) was approved by MFDS (Ministry of Food and Drug Safety of Korea) for Phase I and finished clinical application for the off-the-shelf transplantation. I have known Aseptic Technologies for long time and admire the uniqueness of their products."