Continuous chemistry and cGMP manufacture of pharmaceuticals Continuous chemistry: real-world application


Sterling Pharma Solutions, United Kingdom


A short review of the use of continuous processing in the manufacture of cGMP pharmaceuticals at kilo scale.

Continuous manufacturing is generally used in two areas of pharmaceutical development. The first being in the manufacture of drug substances whereby the active pharmaceutical ingredient (API) is produced, and secondly, in the production of the final drug product that is administered to patients.

To date, no pharmaceutical company has generated a complete cGMP manufacture of an API from beginning to end, although the Massachusetts Institute of Technology (MIT) has published a very interesting paper utilising a modular system to make four APIs in 10’s of grams (1). In addition, there are currently only four drug products that have been approved by the US Food and Drug Administration (FDA) that are produced using continuous commercial manufacture: Vertex’s Orkambi; Janssen’s Prezista; Eli Lilly’s Verzenio and Pfizer’s Davirimo.

In this article with Chemistry Today, Sterling Pharma Solutions’ head of technology and innovation, Mark Muldowney, discusses the potential of continuous chemistry, the benefits it could offer the pharmaceutical industry and the impact regulatory requirements have on its implementation. He also uses several real-wo ...