Curable recently announced on the 20th that it has obtained certification for the application of the Good Manufacturing Practice for Bulk Good Manufacturing Practice (BGMP) implementation status evaluation from the Ministry of Food and Drug Safety. Through this BGMP certification, Curable has established a professional Contract Manufacturing Organization (CMO) system for raw pharmaceutical materials. As a result, Curable has built an optimal system for producing raw pharmaceutical materials for clinical trials necessary for new drug development, positioning itself as a BGMP facility specialized in small-batch, multi-product production, which is rare in Korea.
Typically, BGMP facilities are operated by pharmaceutical companies and raw material specialized companies with large-scale production in mind, often producing in bulk quantities of tons or more. Because of this, it is difficult to support clinical and non-clinical trials required by small-scale researchers such as small pharmaceutical companies, new drug venture companies, universities, and research institutes. In response, Curable plans to strategically implement a 'customer-tailored smart factory' that enables small-batch production of raw pharmaceutical materials for new drug development according to the individual researcher's needs.
Additionally, according to the Drug Master File (DMF) system for raw pharmaceutical material registration, finished drug manufacturers can only use raw materials registered as 'raw pharmaceutical materials' with the Ministry of Food and Drug Safety for drug production. Curable plans to support this requirement by securing manufacturing processes and related documentation through dedicated specialized personnel.
A Curable representative stated, “By establishing an advanced BGMP system and operating an automated system, we have stabilized the CMO business producing raw materials for general synthesis as well as siRNA and ASO pharmaceuticals. By conducting the entire process from research to production within BGMP standards, we have equipped ourselves with an efficient manufacturing system and quality control system.”
Curable is a subsidiary of JW Biotech, a KOSDAQ-listed company, and began preparing for the BGMP-based CMO business in October 2022, receiving facility certification this time. Currently, it is participating in national projects to advance convergent bio-medical product manufacturing technology and is receiving manufacturing requests for raw pharmaceutical materials for new drug development from various pharmaceutical companies and bio research institutes, including the development of wound disinfectants using plasma and dementia treatments.
Meanwhile, Curable plans to fully serve as the best partner for clients’ next-generation new drug development, producing raw pharmaceutical materials needed for non-clinical and clinical trials. Following BGMP facility certification, it will promptly proceed with verification procedures and enter into production agreements with Baekoksaeng Korea regarding cosmetic raw materials and new substances, moving forward with full-scale business operations.
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