Our scientists offer deep expertise in the isolation and purification techniques needed to deliver high-quality materials. We are one of the leading producers of complex APIs using fermentation and subsequent chemical transformation of fermentation products. In addition to lysergic acid derivatives, we introduced immunosuppressants as a new class of fermentation products in the 1990s. Our portfolio includes complex products such as cyclosporine; mycophenolic acid; the mTOR inhibitor, Sirolimus; and the structurally related macrolide lactone, Tacrolimus. We offer all our immunosuppressants at commercial scale. The equipment available for biomass separation includes centrifuges and filter presses; we perform purification via liquid/liquid extraction and chromatography.
Biotransformation, as a synthesis tool, is a key element in our technology portfolio and enables us to provide rapid, cost-effective manufacture of high-purity pharmaceutical intermediates at a commercial scale. We develop enzyme-catalyzed reactions using the selectivity provided by nature to provide efficient reactions under conditions that are ideally suited for the successful commercialization of APIs. We offer comprehensive biocatalysis capabilities, including rapid biocatalytic screening and evaluation, and process development and optimization at both pilot and commercial-scale manufacture.
Research and Process Development
Our scientists bring a strong multidisciplinary approach to biotransformation, in both biocatalysis and organic synthesis, allowing us to select the appropriate chemical or enzymatic catalysis that best suits your project needs. Our biotransformation applications include enantioselective, regioselective and chemoselective reactions. AMRI’s collaborative approach provides us with libraries of enzymes effective in a wide range of conversions and available at large scale. We quickly determine the potential advantages of a particular biocatalytic process and evaluate its competitiveness against alternative synthetic approaches. In addition, we actively pursue new enzymatic routes to solve specific synthesis challenges and optimize enzyme activity to ensure innovative solutions.
Pilot and Commercial-Scale Manufacture
We are renowned for rapid, high-quality manufacture of complex materials and can efficiently scale up processes for commercial needs. Using commercially available enzymes allows us to begin manufacturing your products within short lead times. Our scientists also have world-class expertise in multistep synthesis, which enables us to integrate biotransformation into both upstream and downstream reactions as part of a successful commercial scale-up.
The use of biotransformation to carry out chiral resolutions is an efficient and scalable methodology for separation of a single enantiomer from racemic mixtures. Our scientists have substantial expertise in resolutions of racemic mixtures of esters, acids, alcohols, amino acids and amines using biocatalysis. Additionally, we have experience with lactone and dioxolactone resolutions and separation of isomeric mixtures of various compounds using biocatalysis. Our strength in this area derives from our ability to rapidly integrate a biotransformation step into a chemical synthesis and to scale up such processes quickly to produce multiple kilograms. We then transfer such technologies seamlessly into our multi-tonne production facilities.
We offer products accessible via biocatalysis in enantiopure form:
- Cis-4-acetoxy-2-cyclopenten-1-ol via lipase technology
- Chiral alcohols via ADH technology
- Single enantiomer amines via transaminase technology
- Chiral epoxides via ADH technology
- Chiral acids and alcohols via lipase technology
- Mandelic acid derivatives and other chiral alpha-hydroxycarboxylic acids via oxynitrilase technology