Advancing sustainability in the pharmaceutical industry

Today it seems that our total focus in the pharmaceutical industry is on developing new testing approaches, medications, and vaccines at lightning speed to fight COVID-19, the disease caused by the novel coronavirus. But in the fog of war against the pandemic, we shouldn’t lose sight of the many-years-long effort to make the drug production process more sustainable.

Consumers generally don’t demand that medicines be made with greener processes, but the pharmaceutical industry knows that drug development and production that minimize waste, decrease the use of potentially hazardous substances, and increase safety for workers and the environment—and incidentally, reduce costs—are consistent with its mission to produce lifesaving therapies sustainably.

When the concept of green chemistry crystallized in the late 1990s, it caught the attention of a few sustainability-oriented individuals in the pharmaceutical industry. A few companies started to explore these strategies on their own and decided a collaborative approach might be more effective. So in 2005, the American Chemical Society Green Chemistry Institute (GCI) brought a small group of companies together to form the ACS GCI Pharmaceutical Roundtable. The goal of the roundtable was to catalyze the use of greener chemistry and engineering approaches in the production of pharmaceutical products. In those early days, there were 3 founding members; today the roundtable celebrates its 15th anniversary with 37 members.

One of the first collaborative works produced by the roundtable was a paper published in Green Chemistry outlining the top 12 research areas that would benefit from more sustainable processes. From this initial paper, a grant program was established that awarded academic researchers funding to begin addressing some of these challenges, including preventing waste, designing safer chemicals, and using renewable feedstocks.

Since the first grants were awarded in 2007, the roundtable has provided more than $2.4 million to over 30 research groups around the world. More than 80 publications with over 1,700 citations have resulted from this research. This year, the roundtable plans to award another $250,000 in research funding spread among five topics, including novel approaches to oligonucleotide synthesis and new membrane-based separation technologies.

Lab chemistry is one thing; scaling it to manufacture is another. To that end, the roundtable has developed 11 process design tools and metrics, most of which are available to the public. The Process Mass Intensity Prediction Calculator, one of the first tools, tracks waste generated per kilogram of active pharmaceutical ingredient produced. Today, the calculator includes a streamlined life-cycle assessment. The newest tool is the Analytical Method Greenness Score Calculator, which assesses chromatographic separation technologies.

The roundtable has also produced guides and interactive tools to help select the most appropriate solvents and reagents. The interactive Solvent Selection Tool, powered by a database of 272 solvents, provides solvent characteristics as well as their health, safety, and environmental ratings. The roundtable’s reagents guides, currently covering 19 chemical transformations, profile 150 reagents by their relative greenness, utility, and scalability, with links to relevant research.

Over the past 15 years, the ACS GCI Pharmaceutical Roundtable has expanded its focus beyond small-molecule synthesis. Teams have formed to address medicinal chemistry, biopharma, large- and medium-molecule synthesis, analytical chemistry, flow chemistry, chemistry in water, and emerging issues, such as the use of artificial intelligence and machine learning. Today the roundtable is an ecosystem of interdependent units covering a wide variety of areas. This ecosystem will be on full display at the annual Green Chemistry and Engineering (GC&E) Conference, with the roundtable offering programming covering a variety of topics. This year, the GC&E Conference will be held virtually because of the COVID-19 pandemic, opening the doors for wider participation. The conference will be held June 15–19 and is being offered to participants for free.

In recent years, as the architecture of the pharmaceutical industry has changed, the roundtable has expanded to include more of its supply chain. Members now include major contract manufacturing operations in China and India. Bringing roundtable activities to these countries has been a priority as well—including organizing symposia, workshops, and meetings abroad to better engage Asian companies and researchers.

Meanwhile, ACS GCI has launched other industry roundtables in sectors such as chemical manufacturing, formulations, biochemical technology, and oil field chemistry. The roundtable has shown that such collaborations have a positive return on investment. To learn more about the roundtable, visit www.acsgcipr.org.

Views expressed are those of the author and not necessarily those of C&EN or ACS.