One of the world's largest bio/pharmaceutical services companies, Parexel has entered into a strategic collaboration with the Korea Institute of Industrial Technology (KITECH) over the facility. KITECH plans to operate the multi-purpose, current Good Manufacturing Practice (cGMP)-compliant unit for contract manufacturing purposes.
Parexel said that it would provide the facility - which will operate as part of the Korea Biotechnology Commercialization Centre, with a team of on-site validation engineering consultants located in South Korea as well as US-based engineering and regulatory experts to train KBCC personnel and validate the manufacturing facility, its utilities, and process equipment. Terms of the agreement were not disclosed.
Headquartered in Incheon, South Korea, the KBCC provides cell banking, process and analytical method development and scale-up, regulatory support and manufacturing. It was founded in 1998 by the Korean Ministry of Commerce, Industry, and Energy to provide contract manufacturing services for the production of biopharmaceuticals including genetically engineered protein and monoclonal antibody therapeutics.
The new facility will be the first in the country to comply with US and European standards, and comes at a time when the Korean biotechnology industry is started to grow. Along with other countries such as Singapore and Taiwan, Korea is seeing the number of biotech companies growing almost exponentially, on the back of a significant increase in funding.
The Korean government spent more than $250 million supporting the local biotech industry in 2002, officially the Year of Biotechnology according to the Ministry of Science and technology, and plans to increase this more than eight fold by 2010.
Like similar projects around the world, and notably in the UK, the facility will make it easier for local companies to get access to clinical supplies of biologic drugs.
Parexel has been awarded the contrcat alongside its BioPharm Alliance partner, Germany's Sartorius, which supplies laboratory and process technology. The latter has a local presence in Seoul, South Korea, and will provide bioprocess equipment to be validated by Parexel.