According to CBDMT®, the market and business intelligence company, contract biomanufacturing is a significant market estimated at 2.3 billion this year with an annual growth of about 10 to 15%. Pharmaceutical biomanufacturing could account for more than 20% of the global contract manufacturing market in 2012.
Paris, France (PRWEB) September 15, 2008 -- Biologics are products derived from living organisms or their products. The manufacturing of such biologics involves the culture or manufacturing of living organisms and is named biomanufacturing. According to CBDM.T, biologic drugs (including vaccines), corresponding to less than 12% of global sales in 2001, are expected to contribute 30% of the global drug sales in 2012. Growing pharmaceutical market categories such as vaccines, HIV, neurodegeneration, anti-inflammation, cancer and diabetes reflect continued penetration of biologics. By being derived from living organisms, biologics are complex molecules that are difficult to manufacture. Compared to small molecules, this is a tremendous "advantage" making the development of generic version extremely difficult.
Manufacturing of biologics or biomanufacturing is a multi-step process with a current 60:40 split between mammalian cell culture and microbial fermentation. Today about 60% of all recombinant protein pharmaceuticals are produced in mammalian cells (Avastin, Advate, Erbitux, Rebif, Herceptin, Advate, Fabrazyme…) and 40% are produced in microbial cells (E.coli: Infergen, Ontak, Enbrel and yeast: Novolog, Twinrix Pediarix…). Microbial fermentation is used when smaller and less complex molecules with no post-translational modifications are required (peptides, small proteins, enzymes and antibody fragment). Mammalian cell culture is definitely dominating the manufacturing of complex proteins (glycosylated) and monoclonal antibodies. Transgenics, plant
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