Pharmaceutical manufacturers are showing increased interest in incorporating biocatalysis into manufacturing processes. Using enzymatic approaches in place of traditional chemical synthesis can offer a number of advantages. Enzymes are naturally occurring catalysts that can often provide higher activity and selectivity compared with chemical catalysts, producing a higher yield of chemical product. Enzyme-based processes can be faster and less onerous than traditional syntheses, achieving results with fewer processing steps. Reducing the number of steps can also save considerably on manufacturing costs as a result of the reduced labour and materials requirements, and mean faster delivery of product.
Enzymes are particularly useful for generating isomerically pure pharmaceuticals and fine chemicals. Their chiral active sites can discriminate between different stereoisomers and regioisomers for enantio- and regioselective chiral chemistry.1,2 These advantages can help further to reduce costs and offer considerable benefits for drug development and manufacturing.
Despite the many advantages of biocatalysis, manufacturers have been slow to adopt industrial-scale enzymatic approaches. A significant hurdle has been the requirement for most naturally existing enzymes to undergo artificial optimisation in vitro before they can be used in industrial process conditions. These conditions may involve high temperatures, extreme pH levels and the use of organic solvents and detergents that disrupt natural functioning of enzymes.
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