Process Chemistry News
Case Studies in the Applicability of Drug Substance Design Spaces Developed on the Laboratory Scale to Commercial Manufacturing. OPRD ASAP dx.doi.org/10/1021/op500187u
Nick Thomson from Pfizer is the lead author on this paper from members of the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ), which includes co-authors from several pharma companies. The conclusion is that the need to run design space verification experiments on commercial scale can be obviated by control strategies developed on the basis of sound process understanding, particularly of scale-dependent phenomena. Use of scale-down experiments and predictive models, as well as appropriate PAT monitoring can give assurance that the laboratory process performs well on scale within the design space. The paper discusses these concepts in relation to 6 case histories, one from each of the authors' companies (Pfizer, Lilly, Abbvie, BMS, Biogen, Merck).