Matching the potential of Process Intensification technologies like continuous manufacturing/flow chemistry with the emerging Societal and Business Challenges in Medicines Manufacture and Supply – Part 1 The need for change
ANDREW L. RUTTER
rutterdesign, Saffron Walden, Essex, United Kingdom
Abstract
Flow Chemistry and Continuous Manufacture offer a wider set of chemical transformations for industrial manufacturing processes and in doing so allows intensification and simplification of synthetic routes to complex organic molecules. This technological approach alone does not address the emerging needs for supply of products like medicines; that of a sustainable and resilient supply base that can quickly supply patients. This requires the addition of new approaches to Automation, Digitalisation, Modularity and Modelling to the functionality of Flow Chemistry to achieve a transformation of the design processes and the supply chain for medicine manufacture.
INTRODUCTION
Flow chemistry has been topic of significant research over the last 20 years, and subject to numerous review articles (1-4). This has expanded the available practical chemistry for the synthesis of the complex organic molecules that form the basis of active pharmaceutical ingredients (API’s). As the topic matures, both the range of chemistries possible increases (eg photochemistry (5), synthetic biochemistry (6,7), electrochemistry (8)) and the availability of equipment suppliers and integrators increases, for lab and full scale production.
In this paper I shall be using small molecule API production to explore the link between Process Intensification Technologies like Flow Chemistry, and the emerging societal need for supply of products like medicines. It is written from the viewpoint of an industrialist, not an academic. This is important. Many significant changes are not the result of just one technological innovation but the sum of several changes, technological and business, that enable a new societal need to be met.
Broadly, there are several aspects of medicine product development and com ...