FDA approves greener process for Januvia production
pharmafile | May 1, 2012 | News story | Manufacturing and Production |Â Â Codexis, FDA, Januvia, Merck, manufacturingÂ
The US Food and Drug Administration (FDA) has approved a new, more environmentally-friendly manufacturing process for Merck & Co’s diabetes drug Januvia developed in collaboration with Codexis.
Biocatalysis specialist Codexis said the approved process, which won the Presidential Green Chemistry Award in 2010, can improve the overall yield of sitagliptin, while significantly decreasing waste by-products.
In a paper on the project published in the journal Science (17 June, 2010), Merck and Codexis reported a 10-13% increase in overall yield, a 53% increase in productivity and a 19% reduction in total waste using the improved process.
The key to the process is a novel enzyme that was systematically customised using Codexis technology to perform the key chemical step in the sitagliptin synthesis process, and was suitable for use at commercial-scale production.
Biocatalysts – generally based on enzymes – have been used on a small scale in the pharmaceutical industry for a long time, but it is only in the last few years that they have migrated into the commercial-scale manufacturing environment.
Enzymes are biodegradable, renewable and are generally believed to provide a more sustainable means of chemical synthesis than many currently employed methods used for the manufacture of pharmaceuticals.
“FDA approval of this manufacturing process is a major milestone for Codexis,” said Peter Strumph, the firm’s interim chief executive following the resignation of former president and chief executive Alan Shaw in February.
“This is another example of how our directed evolution technology can deliver well controlled, cost advantaged commercial pharmaceutical, biofuel, or bio-based chemical production processes.”
Pressures on the profitability of drugmakers in recent years have encouraged the industry to cut costs and boost efficiencies across the board, including in manufacturing.
Codexis and Merck are also developing a more efficient manufacturing process for the firm’s recently-approved hepatitis C treatment Victrelis (boceprevir), and have worked together on a new way to make the company’s asthma drug Singulair (montelukast).
Meanwhile, Codexis has also collaborated with Pfizer on a biocatalytic process for the production of Lipitor (atorvastatin), winning the Presidential Green Chemistry Award in 2006 for that project.
Phil Taylor
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