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영어

KBCC(Korea Biotechnology Commercialization Center, located in Songdo Technopark, Incheon city), a part of KITECH(Korea Institute of Industrial Technology), is a government funded initiative set to become an Asia’s leading biopharmaceutical CMO(contract manufacturing organization), capable of manufacturing a wide variety of biopharmaceuticals for clinical and early stage of commercial products. KBCC was established to meet the recent rising demand for cGMP multi-purpose and multi-product biopharmaceutical contract manufacturing capacity in Korea and other areas. KBCC will be a state of the art manufacturing facility that complies with the latest US and EU-GMP regulation and guideline and due to the opening in 2008. The basic engineering design was performed by US engineering company in accordance with the US and EU GMP regulation and guideline, and based on the type C meeting with USA-FDA. The process concepts are campaigned production in one suite, concurrent productions in plant, flexible design (minimal fixed piping & movable equipment), unidirectional personnel/material flows, and two purification rooms (pre and post viral removal room). KBCC quality system and qualification program for cGMP facilities and equipment, supported by US cGMP consulting company, has been designed to meet U. S. Code of Federal Regulations, Parts 210, 211, 820 as well as all other sections applicable, European Union Directives 2003/94/EC and 93/42/EEC, Health Canada, Health Protection Branch (HPB) Pharmaceutical and Medical Device regulations, and ISO Standard 13485:2003.