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Inspiring process innovation via an improved green manufacturing metric: iGAL

Green Chem., 2018, Advance Article
DOI: 10.1039/C8GC00616D, Communication

Inspiring process innovation via an improved green manufacturing metric: iGAL

Frank Roschangar,*^a Yanyan Zhou,^b David J. C. Constable,^c Juan Colberg,^d David P. Dickson,^e Peter J. Dunn,^f Martin D. Eastgate,^g Fabrice Gallou,^h John D. Hayler,ⁱ Stefan G. Koenig,^j Michael E. Kopach,^k David K. Leahy,^l Ingrid Mergelsberg,^m Ulrich Scholz,ⁿ Austin G. Smith,^o Manuel Henry,^p Jason Mulder,^a Jörg Brandenburg,^q Juan R. Dehli,^q Daniel R. Fandrick,^a Keith R. Fandrick,^a Frieder Gnad-Badouin,^q Georg Zerban,^q Klaus Groll,^q Paul T. Anastas,^r Roger A. Sheldon^s^t and Chris H. Senanayake^a

Author affiliations

* Corresponding authors

^a Chemical Development, Boehringer Ingelheim Pharmaceuticals, Ridgefield, USA
E-mail: frank.roschangar@boehringer-ingelheim.com

^b Department of Statistics and Biostatistics, California State University East Bay, Hayward, USA

^c American Chemical Society Green Chemistry Institute, Washington District of Columbia 20036, USA

^d Pharmaceutical Sciences – Worldwide Research & Development, Pfizer, Groton, USA

^e Chemical Process R&D, Teva Pharmaceuticals, Malvern, USA

^f Pfizer, Sandwich, UK

^g Chemical and Synthetic Development, Bristol-Myers Squibb, New Brunswick, USA

^h Chemical & Analytical Development, Novartis Pharma, 4002 Basel, Switzerland

ⁱ API Chemistry, GlaxoSmithKline Medicines Research Centre, Stevenage, UK

^j Small Molecule Process Chemistry, Genentech, a Member of the Roche Group, South San Francisco, USA

^k Small Molecule Design and Development, Eli Lilly and Company, Indianapolis, USA

^l Process Chemistry, Takeda Pharmaceuticals International, Cambridge, USA

^m Process Chemistry, Merck, Rahway, USA

ⁿ Chemical Development, Bayer AG – Pharmaceuticals, Wuppertal 42096, Germany

^o Process Development, Amgen, Thousand Oaks, USA

^p Chemical Process Development, Boehringer Ingelheim Pharma GmbH & Co. KG, 88307 Biberach an der Riß, Germany

^q Chemical Process Development, Boehringer Ingelheim Pharma GmbH & Co. KG, 55216 Ingelheim am Rhein, Germany

^r Yale University, New Haven, USA

^s Molecular Sciences Institute, School of Chemistry, University of the Witwatersrand, Johannesburg, South Africa

^t Delft University of Technology, 2628 BL Delft, Netherlands

Abstract

Following our goal to devise a unified green chemistry metric that inspires innovation in sustainable drug manufacturing across the pharmaceutical industry, we herein disclose joint efforts by IQ, the ACS GCI PR and academia, leading to the significantly improved ‘innovation Green Aspiration Level’ (iGAL) methodology. Backed by the statistical analysis of 64 drug manufacturing processes encompassing 703 steps across 12 companies, we find that iGAL affords an excellent proxy for molecular complexity and presents a valuable molecular weight-based ‘fixed’ goal. iGAL thereby accurately captures the impact of green process inventiveness and improvements, making it a useful innovation-driven green metric. We conclude by introducing the comprehensive, yet easy-to-use and readily adaptable Green Chemistry Innovation Scorecard web calculator, whose graphical output clearly and effectively illustrates the impact of innovation on waste reduction during drug manufacture.