It is urgent for the government to invest in the construction of Good Manufacturing Practice (GMP) facility to commercialize the technology for cell therapies and genetic therapies, a report says.
This is because the private sector will experience difficulties establishing the GNP facility of international standards, which is a prerequisite for exporting the technology developed by the domestic bio venture businesses, it notes.
e Ministry of Food and Drug Safety (MFDS)식품의약품안전처 joined the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme, PIC/S) as the 42nd such government in 2014.
To meet international standards for GMP survey, the ministry has worked out related laws and regulations, such as rules to produce and sell biological drugs and the standards and test methods for biological drugs, as well as some relevant guideline, including standards for making biological drugs and maintaining their quality.
As a result, it has found the government needs to invest in cell and gene therapy facilities, which need a stricter facility and quality management, such as sterile processes, than in making synthetic drugs.
Coordination Center for Global Innovative Biotherapeutics made these and other points in its report emphasizing the need for national support for the GMP facility. The report titled “Buildup of infrastructure for making bio medicines,” commissioned by the Ministry of Science and ICT과학기술정보통신부 and the Ministry of Health and Welfare (MOHW)보건복지부.
"Amid the enormous growth potential of stem cell and gene therapies, investors have poured the massive amount of money worth$10.8 billion (as of 2015) into this area,” it said. “It’s urgent to build infrastructure to preempt the global market."
"Accordingly, the construction of a state-level facility is needed to secure the competitive edge in cell and gene therapies and facilitate the research and development of the related industry," it emphasized.
The ministry has classified cell and gene therapies as high-tech bio medicines ahead of biosimilars and vaccines.
The number of clinical trials approved for cell therapies increased 32 percent last year from 2015k, indicating businesses actively participated in their development.
The global market for cell therapies is estimated to grow from $4 billion in 2015 to $10 billion in 2020, and that for gene therapies, from $300 million to $500 million over the cited period.