The government is pushing to build a research and development programme and a service platform to strengthen domestic bio companies’ chemical, manufacturing and quality control (CMC) capabilities.
The Ministry of Science and ICT said on Monday it is preparing a new project with the Ministry of Trade, Industry and Energy to support domestic companies’ use of CMC services.
Koo Hyuk-chae (구혁채), first vice minister of the Ministry of Science and ICT, attended the "National CMC Industry Development Strategy Seminar to Secure Global Competitiveness" held at the Science and Technology Convention Center on Monday. The seminar, co-hosted by the National New Drug Development Foundation and the Korea CMC Service Industry Research Association, brought together experts from industry, academia and research to discuss strategies to develop the national CMC industry and plans to train specialised personnel.
CMC refers to the full range of activities in new drug development that identify a drug’s chemical characteristics, develop manufacturing processes and manage quality. It is a key foundation for producing candidate substances in a stable way, securing consistent quality and commercialising products that meet global regulatory standards.
In South Korea, CMC infrastructure and support systems are not sufficient, so many bio ventures rely on overseas specialised institutions for related work. The government also judges that this limits efforts to secure sovereignty in advanced therapeutic technologies such as gene and cell therapies and ribonucleic acid (RNA) therapies.
The Ministry of Science and ICT and the Ministry of Trade, Industry and Energy plan to use the new project to conduct R&D on technologies that need to be advanced for CMC application and to build a platform that can provide them as services. They will also support domestic companies pursuing the commercialisation of new drug development to use the platform once built. The plan is to provide a one-stop CMC service package covering the full cycle from candidate substance optimisation to non-clinical and clinical stages.
Koo said: "If advanced process technology played a key role in the success of the semiconductor industry, CMC will play that role in the bio sector." He added: "We will actively communicate with industry, academia and research sites and develop effective support policies so South Korea can leap forward as a global bio powerhouse."