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By Frank Roschangar, Director, Process Research & Global External Chemistry Management, Chemical Development US, Boehringer Ingelheim Pharmaceuticals
The 22nd Annual Green Chemistry & Engineering Conference in Portland, Oregon in June 2018 featured a new interactive workshop concept. Herein, we summarize key outcomes of the workshop titled Metrics - Advances and Limitations in Determining the Greenness of Drug Manufacturing, which was chaired by Frank Roschangar from Boehringer Ingelheim Pharmaceuticals, and featured five expert speakers from the ACS Green Chemistry Institute (GCI) and industry. Each speaker presented their metrics-related topic in just 10 minutes, followed by the deployment of various idea-generating tools, namely SWOT (Strengths, Weaknesses, Opportunities, Threats), PPCO (Pluses, Potentials, Concerns, Overcome concerns; credit: Lisa Bodell, futurethink) and Assumption Reversal (credit: Lisa Bodell, futurethink), to stimulate interactive 15 minute discussions and suggestions for improvements on each topic.
Participants at the Metrics workshop at GC&E in Portland, Oregon. Photo Credit: Naim Hasan Photography
David Constable from ACS GCI presented Green Chemistry Metrics – Yes, you need more than one! He emphasized that researchers ought to apply a system-wide view of chemistry and adopt a multivariate metrics approach to each assessment so that the environmental impact is optimized across the lifecycle of the product. From the subsequent discussion emerged the idea of reaching broad agreement on strategies for using differentiated metrics to effectively drive desired improvements.
Austin Smith from Amgen introduced Inspiring process innovation via an improved green manufacturing metric: iGAL, a new benchmark for manufacturing process waste at each stage of the pipeline. In the interactive session, opportunities were identified such as collecting more data and applying the concept to the pharmaceutical supply chain.
Eric Simmons from Bristol-Myers Squibb offered his perspective on Non-mass based metrics: Assessing environmental, health and safety impacts of chemical processes that led to the development of a comprehensive Process Greenness Scorecard for small-molecule APIs. One opportunity that came out of the discussion was how to build industry consensus around the weightings of the individual metrics.
Michael Kopach from Lilly discussed Metrics for medium-sized drugs: Polypeptides and Oligonucleotides and disclosed that green chemistry has found little application in the preparation of these medium-sized molecules. The audience found this field to have significant potential for adopting or developing adequate metrics to stimulate green innovation.
Sandra Robaire from Merck elaborated on the Streamlined PMI-LCA (Process Mass Intensity – Life Cycle Assessment) Tool for Small Molecules, which was recently streamlined by the ACS GCI Pharmaceutical Roundtable as a more comprehensive tool when compared to mass-based metrics. The ensuing interactive discussion revealed that collecting full LCA data on common reagents and crafting case studies from multiple companies may enhance the value and utilization of the tool. Overall, the sessions were highly participative and well received as such. The output of each session was summarized by the chair and sent to the speakers for their consideration. We are hopeful that several suggestions and ideas will have been followed up and results will be presented at the metrics workshop at the June 2019 Green Chemistry & Engineering conference in Reston, Virginia.