On July 15, 2019, DM Bio (Co-CEO Min Byung-jo, Kawasaki Yoshikuni), a company specializing in the biosimilar business of Dong-A Socio Holdings, announced that its biosimilar production factory located in Songdo International City, Incheon Free Economic Zone had been subjected to a GMP compliance evaluation by PMDA of Japan for 5 days from July 8 to 12.
The PMDA (Pharmaceuticals and Medical Devices Agency), a division of Japan’s Ministry of Health, Labor and Welfare, is responsible for the registration and management of medicines and medical devices.
The PMDA review was conducted in preparation for the commercial production of biosimilars to be sold in Japan in the future.
PMDA specialists in GMP auditing visited the Songdo Factory of DM Bio for an on-site and document review of the overall quality management system, including quality assurance and maintenance, manufacturing facilities and utilities, and product and raw material warehouses.
According to the results of the PMDA evaluation, DM Bio’s quality management system is well operated to minimize noise (defects) based on the SNR (Signal to Noise Ratio), and its Songdo factory is well-prepared for the commercial production of biosimilars. The final results of the PMDA will be released in August.
Established by Dong-A Socio Holdings as a co-investment with Meiji Seika Pharma, a Japanese pharmaceutical company, to enter the biosimilar business, DM Bio has a total production capacity of 8,000L of cGMP antibody biopharmaceuticals. The company not only manufactures products jointly developed with Meiji Seika Pharma, but also conducts a CDMO business that provides such services as contract manufacturing and process development.
An executive of DM Bio said, “We expect to speed up entry into the Japanese market by securing quality competitiveness through the GMP audit by the PMDA. As we have been trying to equip ourselves with the cGMP level system by consulting with Lachman of the US with a view to establishing a foothold in the global market, we will accelerate market entry into Europe and the US, reaching far beyond the Japanese market, by expanding the CDMO business area.”