How a green manufacturing metric can inspire process innovation
The concept of Green Chemistry has evolved alongside pollution prevention ideas in the 1990s. While focusing environmental issues, Green Chemistry at the same time aims at maintaining economic growth and providing services and products to people, thus balancing the long-term sustainability of environment, business and society. In modern pharmaceutical industry, Green Chemistry is indispensable as it leads to more efficient processes, which use fewer and renewable resources, cuts costs and improves the company’s environmental footprint. By lowering the costs for development and manufacturing, Green Chemistry also can contribute to a greater affordability of drugs to patients.
Interview with Dr. Frank Roschangar, Director of Process Research & Global External Chemistry Management at Boehringer Ingelheim
Dr. Frank Roschangar, can chemistry be green?
and helps lowering the costs for development and manufacturing.
By developing and manufacturing drugs that improve patients’ lives, we use chemical processes that produce significant quantities of waste, use energy and employ hazardous substances. Green Chemistry aims at minimizing environmental impact by utilizing sustainable raw materials, reducing waste and energy consumption and replacing hazards while maintaining economic viability. The aspect “green” in chemistry is critical to finding the balance between long-term sustainability of business, society and environment and is thus a great field for innovation, new ideas, novel materials and revolutionary processes.
What does this mean for pharmaceutical processes?
In the pharmaceutical and generics industry, we have projected 15 billion kg of overall annual drug manufacturing waste associated with disposal costs of 30 billion US-Dollar. To reduce waste is not only an environmental but also an economic and social issue. By lowering costs, greener processes help with the development of more affordable drugs and reach more patients.
To enable better measurement of “greenness” but also encourage innovation of greener processes, a team led by you created the new Green Chemistry metric iGAL. What was the key reason for establishing iGAL?
By creating the ‘innovation Green Aspiration Level’ (iGAL), our team accomplished its goal to devise a unified Green Chemistry metric that inspires innovation in sustainable drug manufacturing across the pharmaceutical industry. Importantly, iGAL is easy to use, with calculations to determining Relative Process Greenness (RPG) requiring mere minutes once the process waste has been determined. In addition, unlike its predecessor GAL, by being a fixed goal, iGAL enables full recognition of process innovation via RPG improvements and thus establishes itself as a key link between green chemistry innovation and inspired environmental waste reduction efforts. We at Boehringer Ingelheim believe that this relationship, coupled with the graphically appealing Green Chemistry Innovation Scorecard as an effective communication tool, will achieve our goal to encourage broad adoption within the pharmaceutical and allied industries.
How green is Boehringer Ingelheim?
Boehringer Ingelheim has taken the lead in developing Green Chemistry Metrics when there was an absence of unified metrics. We expect that the implementation of this metric will motivate efforts to reduce environmental footprint while delivering more economical drug development. We also took the lead in introducing the comprehensive yet easy-to-use Green Chemistry Innovation Scorecard web calculator, whose graphical output clearly and effectively illustrates the impact of innovation on waste reduction during drug manufacture.
Applied to the commercial manufacturing process of our product Dabigatran, the scorecard shows the following result: The drug manufacturing process was improved over the course of development to achieve a waste reduction of 65 %, or 163 kg fewer co-produced waste for every kg of produced drug. This is 1.85x less waste compared to industry averages. The Innovation impact shows 157 % overall process improvements.
What impact and benefit do you expect to Boehringer Ingelheim by using iGAL?
I expect that the broad implementation and utilization of the new goal-driven iGAL-based rating system for sustainable drug manufacturing will lead to changes in mindset among our chemists and engineers, and inspire efforts to significantly lower the environmental footprint of Boehringer Ingelheim. Achieving this goal will translate to more economical drug development and manufacture, and can thereby contribute to reducing the manufacturing cost of our drugs which is a critical element for our Access To Medicines markets. The new methodology might also allow us to unify industry to approach government agencies on standards to recognize green manufacturing performance, and thus enable potential rewards such as pharmaceutical “Ecolabels” and expedited drug approvals.
Is Director of Process Research & Global External Chemistry Management at Boehringer Ingelheim, Ridgefield, USA. He has 20 years of in-depth pharmaceutical industry experience with strong scientific background and strategy-oriented business acuity. He leads teams in process chemistry, analytical chemistry, and external chemistry and is responsible for pre-clinical and clinical manufacturing of drug candidates. In 2017 and 2018 he was twice elected co-chair of the ACS Green Chemistry Institute pharmaceutical roundtable, and organized the first roundtable meeting hosted by Boehringer Ingelheim in Ingelheim. He has been selected twice as judge for the US Green Chemistry Challenge Award program by the ACS. Dr. Roschangar obtained a PhD from Rice University in 1996, followed by a Deutsche Forschungsgemeinschaft-sponsored Postdoc at Scripps, and an Executive MBA from Yale in 2014, and has over 50 publications, book chapters and patents.