ACS GCI Pharmaceutical Roundtable reflects on 20 years of growth, collaboration, and sustainable breakthroughs

Twenty years ago, the American Chemical Society Green Chemistry Institute Pharmaceutical Roundtable (ACS GCIPR) launched with the goal of discussing common issues and learning from each member ways to better advance green chemistry within their company as well as to publicize green chemistry successes more effectively. The new roundtable was cochaired by Berkeley “Buzz” Cue of Pfizer and William “Chick” Vladuchick of Eli Lilly and Company.  

The growth of green chemistry

In the early 1990s, as awareness of the effects of chemical processes on the environment was heightening, the term “green chemistry” emerged. This term was coined in an effort to proactively prevent pollution and spur sustainable innovations. In 1998, Paul Anastas and John Warner formalized the foundational principles of green chemistry in their book Green Chemistry: Theory and Practice—principles that chemists still use today.

In 1996, the US Environmental Protection Agency established the Presidential Green Chemistry Challenge Awards to recognize the best examples of the implementation of green chemistry. The EPA offered some of the first awards to pharmaceutical companies that demonstrated that redesigning processes used to manufacture medicines using green chemistry principles could significantly reduce the materials needed and waste generated. By the early 2000s, interest in green chemistry and engineering had increased in the pharmaceutical industry, and companies began exploring metrics to quantify process efficiency improvements. Some companies even established green chemistry programs, such as Pfizer’s Green Chemistry initiative started by Cue. Seeking a way to accelerate the adoption of green chemistry in the pharmaceutical industry, green chemistry leader Anastas, who had retired from the EPA to direct the ACS Green Chemistry Institute (ACS GCI), and Cue, recently retired from Pfizer and a member of the ACS GCI’s governing board, began discussing the possibility of forming a unique organization—a community of practice—to focus on the technical challenges of pharmaceutical green chemistry in a precompetitive or noncompetitive space.

Confronting collaboration

The roundtable launched on January 24, 2005, after months of planning and securing commitments from Pfizer, Merck, and Eli Lilly and Company. At that time, collaboration wasn’t necessarily the dominant culture in the pharmaceutical industry, meaning that there was no guarantee that the ACS GCIPR would be successful. Michael Kopach, associate vice president of Eli Lilly and Company and cochair of the ACS GCIPR, says that initially companies were not sure what areas they could collaborate on. In the pharmaceutical business, companies “compete on the molecule that becomes the active pharmaceutical ingredient (API) . . . how you put that together is effectively done the same way across the entire industry,” says David C. Constable, who was an early roundtable participant from GSK. After they established this noncompetitive space, the first companies at the table quickly identified several projects to start working on together, including benchmarking green chemistry practices in the areas of energy and process design, identifying top chemistry challenges, publishing green chemistry case studies, identifying hurdles to patent extensions, and strategizing how to move green chemistry into earlier phases of the research and discovery process. 

The roundtable’s mission is “to catalyze green chemistry and engineering in the global pharmaceutical industry,” which they hope to accomplish through three priorities: (1) informing and influencing the research agenda, (2) defining and delivering tools for innovation, and (3) educating (future) leaders.

Paul Richardson, director at Pfizer and cochair of the ACS GCIPR, says that they expected the roundtable to grow when they started with 3 companies and other peer organizations within the industry, but the growth to 50 member organizations today was not expected. “Perhaps most appealing regarding this growth is the unique perspectives many of the organizations bring based on their role in the industry,” he says. “This provides a stimulating precompetitive environment for finding tangible and sustainable solutions to the key challenges that the industry as a whole faces.”

Collaboration has also been beneficial to academic collaborators. Daniel Weix of the University of Wisconsin–Madison says the ACS GCIPR has broadened the types of chemistry his group does by providing seed funding and guidance on important green chemistry questions. “The combination of funding along with mentorship from the GCI representatives is unlike other starter grants because dialog taught us about new problems and connected us to potential future collaborators,” Weix says. “These small initial investments in our group have resulted in significant additional funding from industry and government sources.”

Tools, metrics, and road maps

In recent years, green chemistry tools and metrics have become important instruments for meeting corporate sustainability efforts. “Our ambition is that by 2030, 100% of Boehringer Ingelheim’s R&D projects will apply the principles of ecodesign and green chemistry,” says Frank Roschangar of Boehringer Ingelheim. “Being part of the roundtable provides access to cutting-edge green chemistry tools and reinforces the importance of collaboration on sustainable practices to meet our goals.”

“Early on, the roundtable identified the need for standardized tools and metrics to assist chemists in making choices,” says Isamir Martinez, assistant director of portfolio and project management at the ACS GCI. The roundtable adopted the process mass intensity (PMI) metric to benchmark member companies’ processes to identify areas where improvements in the design of synthetic API routes would deliver significant results. “Based on this exercise, solvents were identified as the primary driver of PMI, and the first tool released was a standardized solvent selection tool,” says Martinez. Solvent selection could minimize the amount of solvent needed and offer less hazardous alternatives. Today, the roundtable uses 14 tools and metric calculators, all vetted by members and released to the public free of charge. “I strongly believe that the roundtable’s suite of tools represents tangible evidence of the power of cross-company collaboration,” says Richardson.

“Looking forward to the next 20 years of collaboration among member companies, academia, government, and other groups, GCIPR is working on creating a road map outlining high-impact opportunities to drive decarbonization and incorporate circularity across chemical industry operations while maintaining cost-effective manufacturing processes,” says Juan Colberg of Pfizer. “This road map also aims to achieve our green chemistry goals of reducing chemical hazards, developing sustainable alternative technologies, using renewable feedstocks, enhancing efficiency, reducing waste, and creating sustainable and safe products.”

“Sustainability plays an increasingly critical role in the pharmaceutical industry, impacting everything from drug development and manufacturing to distribution and disposal,” says Kopach. Kopach gave tangible examples of focus areas, including greener synthetic routes to reduce hazardous reagents and waste; biocatalysis and enzyme-based reactions for more efficient chemical transformations; biodegradable drugs and formulations to minimize environmental persistence; continuous manufacturing to improve energy efficiency, particularly for high-volume processes; water conservation, especially in biologics and peptide synthesis; and reduction of single-use plastics in packaging and drug delivery systems.

Major breakthroughs in the last 20 years

Since the adoption of green chemistry in the pharmaceutical industry, there have been a handful of notable sustainability breakthroughs in the industry—breakthroughs like biocatalysis and enzyme-based synthesis, an area in which Merck has received a number of sustainability awards; continuous manufacturing processes, which reduce waste, energy consumption, and production time; green solvents and alternative reagents, which reduce the use of hazardous organic solvents; peptide-based therapies (because peptides naturally degrade into amino acids, these therapies minimize environmental impact, and peptide synthesis often does not require mammalian cell culture, which significantly reduces water, energy, and resource consumption); mRNA therapeutics, which reduce water, nutrient, and energy use (because mRNA production does not require cell culture, and mRNA offers faster and scalable production); and the development of easy-to-use metrics like the PMI, which have helped companies implement more sustainable practices.

A natural synergy

The ACS GCI says that green chemistry and engineering provide chemists with practical tools to deliver innovative commercial products that minimize environmental impact, safeguard human health, and build toward renewable, regenerative, and nature-based technologies and systems. The pharmaceutical industry is tasked with safeguarding human health by providing life-saving medicines and vaccines, meaning that green and sustainable chemistry approaches have many synergies with corporate goals.

“While the health and safety of the patient naturally represents the absolute priority of the industry, the role that sustainability plays—given that we operate in a global environment—can never be understated,” says Richardson. “Having robust sustainability goals represents an absolute imperative for organizations and provides the opportunity to realize benefits from a societal, environmental, and business perspective.”

“As an initiative within the ACS Green Chemistry Institute, this partnership with industry demonstrates how a scientific society can be the catalyst for real change within an industry, resulting in improved processes, technologies, and methods that are having a real impact on the way medicines are made today,” says Martinez.