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. Compared with the manufacture of the same amount of product in a traditional facility, our next-generation biomanufacturing plant in Singapore has so far demonstrated reductions of approximately 268,000 gigajoules of energy, 8,800 metric tons of carbon and 82,000 cubic meters of water.
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. In 2017, the United States Environmental Protection Agency honored Amgen with a 2017 Green Chemistry Challenge Award for green chemistry practices, developed in partnership with Bachem, that we applied to the development and manufacture of the synthetic peptide drug Parsabiv™ (etelcalcetide).
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.
We are developing continuous-flow chemistry manufacturing processes for production of our synthetic molecules. This nimble approach, where material is made on an as-needed basis in small containers rather than large tank batches, will help to reduce the manufacturing footprint, conserve energy and reduce drug substance scrap amounts. This process also provides for precise temperature controls mitigating safety risks associated with high temperature operations. We are also pursuing a variation of this approach to produce biologic molecules to continue to innovate for process optimization, reducing environmental footprint and reducing costs of developing and manufacturing medicines.
Sharing Best Practices
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 sub-groups related both to synthetic molecule and biologic molecule processes.
Brian Sparling, an Amgen senior scientist who 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 sub-team, contributed to a 2017 paper with sub-team colleagues, "Sustainable Practices in Medicinal Chemistry Part 2: Green by Design" in the Journal of Medicinal Chemistry. Amgen is also a sitting member on the IQ Green Chemistry working group, a collaborative team which focuses on driving innovation and awareness of green chemistry in the pharmaceutical industry. Austin Smith, an Amgen scientist who is chair of Amgen's Process Development Green chemistry team, published a 2018 paper with IQ colleagues 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 and Austin presented a poster on "Greenness at Amgen" at the ACS Green Chemistry and Engineering conference in June of 2017, and Brian chaired a session at the conference on new, green chemical methodology. To promote more sustainable practices in our biologics research and development and manufacturing, Larry Sun, senior engineer, also participates on the ACS GC Pharmaceutical Roundtable's Biofocus Group.
Our scientists are engaging in efforts to bring green chemistry knowledge to educators and students. Amgen staff have given talks and presented posters in several educational settings including 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.
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.