Custom metabolite synthesis service

California-based enzyme specialist BioCatalytics has launched a custom drug metabolite synthesis service aimed at the pharmaceutical sector, building on its capabilities in using enzymes for the synthesis of drug substances.

The basis for the new service is the company's expertise in the use of human cytochrome biocatalysts, a specially formulated human liver enzyme enabling the production of drug metabolites in less time and at lower cost than other methods.

Metabolites are produced when drugs are metabolised by enzymes in the liver; they are chemically distinct compounds that can have different toxicity profiles or biological activities from the drugs from which they are derived, explained Dr David Rozzell, president and ceo of BioCatalytics.

'About 80% of drugs are metabolised by cytochrome enzymes in the liver, and most of the time when those fail in the clinic it is down to problems caused not by the drug itself but by metabolites of that drug,' he said. 'Therefore the need to understand the potential for side-effects and drug-drug interactions is driving an increased need to produce and study these drug metabolites prior to human testing of drugs.'

The company launched what it believes was the world's first human cytochrome biocatalyst in 2004 in a synthetically useful, lyophilised formulation. The custom synthesis service will enable it to produce the metabolites from drugs in a one-step process, enabling a rapid turnaround, and in higher yields than can be produced by other methods like chemical synthesis.

BioCatalytics has also appointed Nagase as the exclusive distributor for its enzyme and fine chemical products in Japan and other Asian countries. Nagase is a speciality and fine chemical manufacturer and distributor in Japan, but also serves other Asian countries such as China, India and Korea.

'As a small US producer we have never had a direct presence in the Far East and we have been looking for some time for the right company to partner with,' said Rozzell. 'This agreement makes our full product range, including the human cytochrome biocatalysts, available in Japan for the first time,and will dramatically improve our ability to serve our customers in Asia.'