Objective

Drug manufacturing is more competitive than ever and to reduce the cost of active pharmaceutical ingredients (APIs), industry continues to invest in new manufacturing technologies such as biocatalysis, continuous flow and chemical catalysis. Biocatalysis, in particular, has had a real impact on the synthesis of APIs. The synthetic and competitive advantages of biocatalytic processes is demonstrated by the uptake of this methodology into an increasing number of manufacturing processes. The key drivers for this are the significant advantages in the production of chiral intermediates where the regio- and stereo-selectivity of the enzyme can be harnessed to generate enantiopure products and access to the desired enzyme. The application of enzymes has enabled improved syntheses through the generation of molecules that would otherwise be either impossible or impractical to synthesise. Within GSK, the Synthetic Biochemistry community has been investigating in infrastructure, people and technology to enable more biocatalytic reactions. Enzymes such as epoxide hydrolases, imine reductases, transaminases or keto reductases have been successfully applied by GSK and incorporated into API manufacture for clinical & commercial campaigns.