Contributed by Frank Roschangar, Director, Chemical Development, Boehringer Ingelheim Pharmaceuticals

 

Collaborators: Juan Colberg (Pfizer), Peter J. Dunn (Pfizer – retired), Fabrice Gallou (Novartis), John D. Hayler (GlaxoSmithKline), Stefan G. Koenig (Genentech), Michael E. Kopach (Eli Lilly), David K. Leahy (Bristol-Myers Squibb), Ingrid Mergelsberg (Merck), John L. Tucker (Amgen), Roger A. Sheldon (Delft University of Technology), and Chris H. Senanayake (Boehringer Ingelheim)

 

Green and sustainable chemistry is critical for balancing the long-term sustainability of business, society, and the environment. It stimulates scientific innovation, reduces environmental footprint, lowers development and manufacturing costs, and can therefore contribute to the greater affordability of drugs for patients. However, the full potential of sustainable drug manufacturing has been inhibited by the absence of harmonized green chemistry metrics, inconsistent starting points for analysis, and the neglected complexities of the diverse manufacturing processes. Seeing this, nine large pharmaceutical firms from the IQ Consortium Green Chemistry Working Group and the ACS Green Chemistry Institute Pharmaceutical Roundtable, together with Professor Sheldon, the inventor of the E factor, joined their efforts to mitigate these problems.

 

They formulated the critically needed, unified and innovative green manufacturing measure, Green Aspiration Level (GAL), which exceeds conventional approaches to green chemistry metrics for the entire industry and provides the ultimate benefit to both the environment and the patient (Green Chem. 2017, 17, Advance Article). Their research substantially advances and expands on earlier methodology (Green Chem. 2015, 17, 752–768) with a detailed analysis on a data set of 46 drug manufacturing processes, including the oft-neglected, outsourced production and early supply chain segments, and a validation that the GAL enables consistent and meaningful green manufacturing analyses in the pharmaceutical industry for the very first time. GAL is very easy to use, with analysis requiring mere minutes to develop once process E factors or PMIs have been determined.

 

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In addition, the researchers introduced a novel reporting tool – the Green Scorecard – in their work that acts as a value-added communication strategy that captures key information for executive leadership and facilitates the tool’s widespread industrial adoption. Its application is showcased, for example, in the commercial Pradaxa manufacturing process (see Figure). The Scorecard calculator, along with detailed instruction, is freely available at the IQ Green Chemistry website.

 

The chemists expect that a broad implementation and utilization of the new goal-driven GAL-based rating system for green and sustainable drug manufacturing will lead to changes in mindset among industry leaders and motivate efforts to significantly lower the environmental footprint of the pharmaceutical industry. Achieving this goal will motivate more economical drug development and manufacture, and thereby contribute to reducing the cost of drugs to patients.

 

The new insights and ideas presented in their research are not only aimed at inspiring and realizing greener manufacturing processes within the pharmaceutical industry, but they can also have widespread implications for broader fine chemical manufacture. The chemists therefore hope to influence green thinking and stimulate discussion within diverse scientific and industrial communities to ultimately lead to the broad adoption of the new methodology among them, as well as the realization of the aforementioned benefits to society.

 

 

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