Chemical Process Development in the Pharmaceutical Industry in Europe—Insights and Perspectives from Industry Scientists
Joachim I. Krueger, André P. Dieskau, Jorma Hassfeld, Joerg Gries, Oliver Block, Hilmar Weinmann, Daniel Kaufmann, Stefan Hildbrand, Volker Kraft, Robert Moeckel, Juan R. Dehli, Ulrich Scholz, Carl F. Nising
Abstract
Chemical process development is a critical component in the development process for active pharmaceutical ingredients (APIs). With interfaces to drug discovery and API manufacturing, chemical process development activities must deliver scalable, safe, cost-efficient, sustainable, and reliable processes for novel as well as marketed APIs. Despite its importance for the pharmaceutical industry and society, the domain of chemical process development, together with its advances and challenges, is often not well known to nonpractitioners. As industry scientists, we provide a scientific perspective on the state of affairs in chemical process development, which we believe will be of value to a broader audience, including academic researchers, students, and professionals from related fields.