Green chemistry and sustainability metrics in the pharmaceutical manufacturing sector

This review article summarizes recent developments of green chemistry and sustainability metrics with a focus on the pharmaceutical industry. We discuss synergies and discrepancies of the green chemistry principles with regulatory guidelines in the field of pharmaceutical process development and manufacturing under Good Manufacturing Practices (GMP). This review captures selected views and publications on green chemistry and sustainability metrics. It discusses two recent process development highlights from the pharmaceutical industry which use different approaches to optimize the process mass intensity (PMI) of small-molecule active pharmaceutical ingredient (API) manufacturing processes. The first example is the development of green process conditions by switching reaction media from organic solvents to micellar catalysis in water in the Takeda process of the API TAK-954. The second example features process intensifications accomplished by the application of innovative technologies in pharmaceutical processing in the Merck process of the API MK-7264.