Chapter 8: From Discovery to Manufacturing: Some Sustainability Challenges Presented by the Requirements of Medicine Development
Published:08 Mar 2016
J. Hayler, in Green and Sustainable Medicinal Chemistry: Methods, Tools and Strategies for the 21st Century Pharmaceutical Industry, ed. L. Summerton, H. F. Sneddon, L. C. Jones, and J. H. Clark, The Royal Society of Chemistry, 2016, ch. 8, pp. 82-100.
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The discovery and development of a new medicine is a long and complicated endeavour requiring the contribution of multiple teams of people over many years. This chapter considers the activities required to develop the synthesis of a small molecule active pharmaceutical ingredient (API) to support development through to regulatory submission. The changing nature and requirements of a synthetic route to API are discussed as well as the ideal criteria for a manufacturing route (SELECT) and their alignment with many of the 12 principles of green chemistry. Process development ensures that the manufacturing route provides consistent delivery of API of defined quality to ensure drug product efficacy and safety for the patient. The key quality requirements are discussed as well as an introduction to the concept of quality by design, which encourages greater scientific understanding of the chemistry and process control required to deliver API of acceptable quality. The chapter concludes by considering the potential sustainability impact of the responses to historic compound and the challenging environment in which the chemistry team must deliver the manufacturing route.