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| home > epc > summer 2004 > manufacturing recombinant proteins: facing up to the challenges of making tomorrow's medicines |
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European Pharmaceutical Contractor
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Tremendous advances have been made since 1982, when the first biopharmaceutical product, recombinant human insulin, was launched. Currently over 120 such products are being marketed, including nine blockbuster drugs. The global market for biopharmaceuticals, currently valued at US$41 billion, has been growing at a compound annual growth rate of 21 per cent over the last five years. Over one-third of all pipeline products in active development are biopharmaceuticals and it is predicted that this segment is set to continue, outperforming the total pharmaceutical market and reaching US$200 billion by the end of the decade.
Currently, 35 per cent of biomanufacturers outsource at least some of their biologic production in mammalian, microbial, yeast, plant or insect cells, and a recent survey predicted that within the next four to five years nearly half of all biopharmaceutical manufacturers may be outsourcing production of biologics to contract manufacturing organisations (CMOs) (1).
Therapeutic proteins, including antibodies and their fragments, antigens, enzymes, hormones and growth factors make up a significant proportion of all biologics. Companies with limited or no in-house process development and manufacturing capabilities are developing many of these novel biopharmaceuticals, but they must outsource the biomanufacture of materials for clinical trials to CMOs. Producing high quality, efficacious and safe proteins in sufficient amounts for the clinic is not trivial and poses many multidisciplinary challenges for CMOs.
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Industry Events |
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4th Annual Patient Recruitment and Retention in Clinical Trials
13-15 October 2008, Amsterdam
Patient recruitment
is now consuming thirty percent of clinical trial time - more time than any
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As the
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