SC Engineering "Cellontech Obtains Re-approval for Advanced Biopharmaceutical Manufacturing and Products from MFDS"

[Asia Economy Reporter Hyunseok Yoo] SC Engineering announced on the 27th that its affiliate, the regenerative medicine specialized bio company Cellontech, has obtained reauthorization from the Ministry of Food and Drug Safety (MFDS) for advanced biopharmaceutical manufacturing and advanced biopharmaceutical product items.

With the enforcement of the "Act on the Safety and Support of Advanced Regenerative Medicine and Advanced Biopharmaceuticals (Advanced Regenerative Bio Act)" in August last year, manufacturers of advanced biopharmaceuticals such as cell therapy and gene therapy products are now required to obtain reauthorization under the Advanced Regenerative Bio Act standards for manufacturing and product approvals previously granted under the Pharmaceutical Affairs Act.

To acquire manufacturing authorization for advanced biopharmaceuticals, facilities and equipment capable of producing advanced biopharmaceuticals, as well as an independent testing laboratory for raw materials, supplies, and quality control, are required. Additionally, requirements include equipment and instruments necessary for testing, storage facilities to safely store raw materials, supplies, and advanced biopharmaceuticals, personnel, and operational systems.

Cellontech obtained pharmaceutical manufacturing authorization in 2001 and secured product approval for ‘Condron (RMS autologous cartilage-derived chondrocytes)’, the first domestic biopharmaceutical in Korea. Subsequently, in 2009, ‘RMS Osron (RMS autologous bone marrow-derived bone cells)’ received product approval. With the recent acquisition of advanced biopharmaceutical product authorization, both ‘Condron’ and ‘RMS Osron’ have completed reauthorization as advanced biopharmaceuticals.

A Cellontech representative emphasized, “This reauthorization has established a foundation to accelerate new drug pipeline research and development (R&D) in the advanced biopharmaceutical field, as well as new business initiatives in contract manufacturing (CMO) and contract development and manufacturing (CDMO).”

They added, “Cellontech has led the foundation and growth of the domestic regenerative medicine industry for over 20 years, including becoming the world’s second company to successfully commercialize cell therapy products. Based on our proprietary regenerative medicine technology know-how and the MFDS reauthorized advanced biopharmaceutical GMP (Good Manufacturing Practice) production facilities, we will collaborate with bio companies facing challenges due to lack of facilities and experience to create new added value.”

This content was produced with the assistance of AI translation services.