Case Studies illustrating a science and risk-based approach to ensuring drug quality when using enzymes in the manufacture of Active Pharmaceuticals Ingredients for oral dosage form.

An important area to address when developing new and more sustainable methodolgies for API manufacturing are  non-technical   barriers to the  uptake of the emerging technology.A number of  CHEM 21 members have collaborated with a range of other multi-national pharmaceutical companies and biotechnology suppliers to produce a white paper to support the uptake of biocatalysis in the manufacture of API’s. The paper details some case studies on  medicines both  in development and approved for patients,  and provides some practical guidance around quality issues to promote  the uptake of biocatalysis .

The 2016 Organic Process Research and Development paper has just been  just accepted and can be viewed at:http://pubs.acs.org/doi/abs/10.1021/acs.oprd.5b00369