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.

Challenges

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.

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Project Summary

Established in 2011, CEFO Co., which stands for “Cell Engineering For Origin” develops targeted cell therapy to cure intractable human diseases. Their CF-M801, an allogenic osteoblastic cell therapy for osteonecrosis of the femoral head (ONFH), has been approved by MFDS (Ministry of Food and Drug Safety of Korea) for Phase I and finished cell transplantation for nine patients. There was no adverse effect and immune rejection of allogenic osteoblasts. CF-M801 will extend its application to osteoporotic fracture, and adjuvant therapy to interbody cage-based spinal fusion. Their next-generation NK cell-based-cancer immunotherapy (CEN-K) is in pre-clinical study.

The introduction of the AT-Closed Vial® technology, which started with the small batch filling process Crystal™ M1, allows for safe aseptic fill & finish of the cell therapy CF-M801 in Phase I.

The scalability of the filling technology can support the further clinical trials needs of this allogeneic therapy. The AT-Closed Vial® process and its design contribute to the safety of the cryogenic storage and the ease of the administration procedures in the hospital.

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."