We have just published an article on “Accessing Difficult-to-Synthesise Metabolites in Drug Development Programmes” in the April 2019 edition of European Biopharmaceutical Review. Access to major and/or disproportionate metabolites is important to ensure adherence to regulatory guidelines issued by the FDA and EMA, as well as to comply with internal safety standards set by pharmaceutical companies themselves.
In this article Julia Shanu-Wilson uses a variety of case studies, assembled from real projects undertaken at Hypha, to illustrate the use of different biological methods to access drug metabolites, including metabolites generated by the action of aldehyde oxidase, N-glucuronidation and through the action of gut microbiota. Methods covered include incubation of drugs with liver fractions, recombinant CYP enzymes, microbial biotransformation and direct purification of metabolites from clinical materials.
