Lonza steps into contract manufacturing of large scale therapeutic peptide production
Basel, October 27, 2000 - Following increasing demand for large scale peptide production in a growing global peptide pharmaceutical market, Lonza enters large scale microbial peptide manufacturing, using state-of-the art fermentation and down stream processing technology. This enables Lonza to cost effectively produce peptides of quantities greater than 100 kg.
The global peptide pharmaceutical market was estimated at $ 350 million in 1999, at the active pharmaceutical ingredient (APIs) level. Driven by recent advances in formulation technology, alternative non-parenteral delivery systems and more cost efficient API production methods, the market for therapeutic bulk peptides is expected to grow at an above average annual growth rate of over >15 % and could reach between $ 800 and $ 900 million by the year 2005.
Peptides, like proteins are biologically very active molecules and target specific diseases. They are relatively fragile molecules and are often quickly inactivated by digestive enzymes in the stomach, being degraded to constituent amino acids. To achieve effective delivery of the active peptide, the drugs can be injected, applied as a slow release patch under the skin or applied topically.
Large scale peptide manufacturing of quantities greater than 100 kg is still a highly cost-intensive endeavour, especially for long chain peptides. Lonza?s strategy is to minimize costs of a given process by maximizing throughput and minimizing assets, raw materials and solvent usage. A cost-effective process for long chain peptides might be combining chemically manufactured peptide fragments, an efficient fermentation process, or even an integrated approach of a recombinant fermentation process together with chemical methods.
For a number of years Lonza has been involved in the development of new processes using recombinant microbial strains for the production of peptides, in combination with appropriate down stream processing (DSP). In collaboration with The Medicines Company, Cambridge, MA, Lonza recently developed and scaled-up a new recombinant process for the production of a key peptide intermediate for the semi-synthesis of the bulk active pharmaceutical peptide, bivalirudin, a bivalent thrombin inhibitor under review by the US FDA for use in cardiovascular indications.
As one of the leading fine chemical producers, Lonza can rely on its existing infrastructure for large-scale solvent recovery and waste
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