Work has already begun to expand laboratory space at Peptisyntha's cGMP-compliant manufacturing facilities in Torrance and will be completed by March 2005. Once completed, the new space will have two additional suites to manufacture large scale cGMP peptides.
First coming to prominence as a source of drugs in the 1980s, peptides are molecules made up of two or more (up to 100 to 150) amino acids, with the most well known peptide-based drug being insulin. Because they are large molecules and easily degraded by digestive enzymes, peptides have traditionally been restricted by their need to be delivered by injection.
Latterly, with the advent of new drug-delivery systems such as skin patches, inhalers and sprays, peptide drugs have become more appealing development prospects and are predicted to grow at a rate of 15-20 per cent a year - double that projected for active pharmaceutical ingredients (APIs) as a whole. As a result, pharmaceutical companies have consequently revived or begun peptide programs, and biotech companies focusing on proteins have also directed their resources at peptides.
"This additional working space will allow us to better serve our customers and meet increasing demand for our products and services," said Shima Joshi, Peptisyntha's vice president of Operations.
At present there are around 35 peptide drugs on the market, with the most recent entrant being Roche's Fuzeon (enfuvirtide), a new class of drug for the treatment of HIV infection. Other top-selling peptides include AstraZeneca's (goserelin) and Aventis's Suprefact (buserelin).
Peptisyntha Inc operates as a wholly owned subsidiary of Solvay America and as an affiliate of Belgium's Peptisyntha. The latter has a proprietary solution-phase technology for peptide synthesis - in which the growing peptide chain is anchored to a resin - which enables the cost-effective scale up of commercial quantities required by the biopharmaceutical industry.
Other companies active in the contract manufacture of peptides include UCB, Bachem, Lonza, CSS and Isochem subsidiary Neosystems.