Sustainable Research and Manufacturing
Amgen helped invent the processes and tools that created the global biotech industry. As we continue to grow and innovate, we are pioneering advanced technologies for research and development and manufacturing to increase operational efficiency, improve access to our medicines and reduce our environmental footprint across a range of drug modalities.
Amgen has pioneered modular, flexible next-generation biomanufacturing technologies that are more environmentally friendly than conventional biomanufacturing. Our next-generation biomanufacturing plant in Singapore uses a fraction of the energy and water in manufacturing when compared with the manufacture of the same amount of product in a traditional facility.
In the areas of medicinal chemistry research and synthetic drug development and manufacturing, Amgen has a well-established and distinguished track record for using green chemistry practices. As we continuously seek to discover and make medicines for patients more quickly and affordably, green chemistry practices become ever more enabling of this goal. As a key example, Amgen was honored with a 2017 Green Chemistry Challenge Award from the U.S. Environmental Protection Agency for green chemistry practices, developed in partnership with Bachem, that we applied to the development and manufacture of the synthetic peptide drug Parsabiv™ (etelcalcetide). The core of this award-winning approach was the switch to a new process that reduces the use of solvent by thousands of liters along with weeks of production time per batch of medicine. This work was also highlighted in the Journal of Organic Chemistry in a 2019 paper titled “Sustainability Challenges in Peptide Synthesis and Purification: From R&D to Production” that was co-authored by Austin Smith, a senior scientist in Amgen’s Drug Substance Process Development group who is chair of Amgen’s Process Development Green Chemistry team.
There are other examples in projects across the development cycle at Amgen where green chemistry combined with out-of-the-box thinking is creating benefits. A highlight includes the use of engineered enzymes to perform new and novel transformations, which before could only be accomplished with precious metal catalysts requiring certain controls to mitigate hazardous conditions. In another example, we are using light-induced cycloaddition to reduce process time and eliminate the use of hazardous reagents like cyanide and bromine. As these examples show, green chemistry is a critical enabler for the advancement of our portfolio of products, not just something we do when it is easy or convenient.
In overall process innovation, we are continuing to strengthen our capabilities in synthetics continuous manufacturing. This nimble approach, where material is made in small containers rather than large tank reactors, can help to reduce the manufacturing footprint, conserve energy and help us overcome challenges related to the implementation of certain chemical reactions. This capability provides for precise control of variables, such as temperature to mitigate safety risks associated with high or cryogenic temperature operations, and enables the use of reactive intermediates that would be challenging to control in batch mode. To facilitate the development of continuous manufacturing, our scientists designed new and flexible hood enclosures. We are also pursuing a variation of continuous manufacturing for the manufacture of biologic molecules to continue to optimize processes, increase speed, reduce costs and improve the environmental footprint associated with developing and manufacturing medicines.
In 2017, we assessed two platform approaches in our biologics portfolio to calculate process mass intensity—a measure of material and resource efficiency in drug substance manufacturing. These calculations are intended to serve as benchmarks against which to measure future process changes across our Process Development organization including changes in the environmental footprint of the manufacture of our medicines.
Staff Engagement/Industry Partnerships
Amgen staff have a history of participation in green chemistry teams that promote more environmentally friendly practices and give prizes for most innovative green practices that save energy and water and reduce waste. A staff engagement program to encourage our researchers to shut the window sashes of their fume hoods when not in use continues to provide operational cost savings and improve our green footprint. In 2018, world-renowned chemists Dr. B. Frank Gupton and Dr. Tyler McQuade from Virginia Commonwealth University spoke to staff about streamlining organic synthesis through process intensification as featured speakers at Amgen’s annual green chemistry symposium.
Amgen participates in the American Chemical Society (ACS) Green Chemistry Institute (GCI) Pharmaceutical Roundtable to share and learn best practices for more sustainable research and development and manufacturing of medicines. Staff members participate in ACS GCI Pharmaceutical Roundtable subgroups related both to synthetic molecule and biologic molecule processes. Amgen Senior Scientist Brian Sparling is chair of Amgen’s Medicinal Green Chemistry group as well as the leader for the American Chemistry Society (ACS) Green Chemistry Institute Pharmaceutical Roundtable Medicinal Chemistry subteam. To promote more sustainable practices in our biologics research and development and manufacturing, Larry Sun, senior engineer, also participates on the ACS GCI Pharmaceutical Roundtable’s Biofocus Group. Amgen is also a sitting member on the IQ Green Chemistry working group, a collaborative team that focuses on driving innovation and awareness of green chemistry in the pharmaceutical industry.
Our scientists are engaging in efforts to bring green chemistry knowledge to educators and students. In 2018, Brian led a cross-industry “Green Chemistry in the Pharmaceutical Industry” workshop at Massachusetts Institute of Technology in affiliation with the American Chemical Society Green Chemistry Institute Pharmaceutical Roundtable, with representation from Amgen, Merck, Pfizer, Biogen, Novartis and the American Chemical Society. Also, in 2018, members from Amgen’s Medicinal Chemistry team spoke about the benefits of green chemistry approaches with students at Caltech, Pepperdine, UMass Boston and Stanford. Other educational settings in which Amgen scientists have presented include the Warner Babcock Institute/Beyond Benign, the Northeastern University American Chemical Society undergraduate student chapter, Stanford University’s Johnson Symposium and Boston College. Amgen scientists have served as panelists on IQ webinars highlighting the importance of green chemistry in the pharmaceutical industry.
Papers and Presentations
In 2019, Larry Sun contributed to a paper “Introduction of a Process Mass Intensity Metric for Biologics,” published in the journal, New Biotechnology, which highlighted how metrics such as process mass intensity can help identify areas for improvement in the environmental footprint of the manufacture of biologic medicines.
Austin Smith co-authored a 2018 paper in Green Chemistry titled "Inspiring Process Innovation via an Improved Green Manufacturing Metric: iGAL." The paper focuses on new green metrics to enable a more impactful quantitative analysis of process waste in pharma manufacturing.
Brian Sparling contributed to a 2017 paper "Sustainable Practices in Medicinal Chemistry Part 2: Green by Design" in the Journal of Medicinal Chemistry.
Austin and Brian presented a poster on "Greenness at Amgen" at the ACS Green Chemistry and Engineering Conference in June 2017, and Brian chaired a session at the conference on new green chemical methodology.
Recycling in Our Plants and Labs
We seek to reduce waste associated with research and manufacturing when possible. We have expanded capability for recycling waste associated with research and manufacturing, including the recycling of plastics, foam rubber and glass.