Daewoong Pharmaceutical, KITECH Sign MOU for Biopharma cGMP Facilities



Daewoong Pharmaceutical secures manufacturing facilities to serve US and European markets and plans to conduct clinical trials in Europe by 2007.

Daewoong Pharmaceutical and Korea Institute of Industrial Technology signed a Memorandum of Understanding (MOU) for the use of biopharma cGMP facilities. A cGMP facility, the abbreviation of current good manufacturing practice facility, indicates a facility that manufactures raw materials for drugs, animal drug products, and finished drug products that satisfy ‘good manufacturing practices’ according to the US FDA.

Korea currently has many GMP facilities, but has no US FDA certified cGMP. With the recent MOU agreement signed for biopharma cGMP facilities, Daewoong Pharmaceutical is now able to secure facilities that will enable therapeutic proteins, which were developed based on its core competence in bioengineering, to find their markets in the US and Europe. Daewoong Pharmaceutical is planning to manufacture clinical trial materials using biopharma’s large-scale facilities that satisfy international standards and are planning to conduct clinical trials in Europe by 2007.

Since Daewoong Pharmaceutical secured for the first time in Korea the rights on basic technology for human antibody development last July from Haptogen, a Scottish venture business, specializing in antibodies, it has since obtained a foothold in bioengineering enterprise with international competitiveness by securing cGMP manufacturing facilities suitable for branching into advanced markets abroad.

In the future, it is planning to focus on developing human antibody for cancers, liver diseases, and immune system diseases to secure a novel antibody drug pipeline. Also, the cGMP facilities at KITECH will be utilized to manufacture clinical trial materials for branching into advanced markets abroad.