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영어

Biopharmaceuticals are medical drugs produced using biotechnology. They are proteins (including antibodies) and nucleic acids (DNA, RNA or antisense oligonucleotides) used for therapeutic or in vivo diagnostic purposes. These so called large molecule pharmaceuticals can be produced from recombinant microbial cells, mammalian cell lines or plant cell cultures. Biopharmaceuticals are typically large molecules, requires complex post translational modification and glycosylation processes. Its glycosylation pattern affects biological activity, function, clearance from blood circulation, and most importantly it could also elicit immune response in patients. Due to that reasons, bacteria, yeasts, fungi, insects and plants are generally not suitable for the expression of therapeutic glycoproteins such as antibodies. The worldwide market for therapeutic and diagnostic monoclonal antibodies is expected to reach USD$26 billion by 2010. First Antibody for pharmaceutical was approved in 1986 and currently there are more than 23 therapeutic antibodies approved by US FDA in the market. The numbers are still growing. With hundreds of product candidates in the pipeline getting into clinical stage phase I, II and III, there is a huge demand for contract manufacturing sector as well. InnoBio operates as a contract manufacturer (CMO) and is positioning itself as one of the player for biopharmaceutical production. Established in 2003, the services include all stages of the production of mammalian cell-based therapeutic proteins and monoclonal antibodies, from DNA recombination work and bioprocess development to cGMP manufacturing. In this talk, the experience in setting up a cGMP manufacturing plant and manpower development together with support facility will be discussed.