Amgen helped invent the processes and tools that created the global biotech industry. And we never stop innovating. As we continue to improve our approaches for research and development and manufacturing, we are making them more efficient and also reducing the environmental footprint of our medicines.
Amgen is now studying an impressive number of drug modalities. Our environmental sustainability efforts primarily address our work with small molecule, therapeutic protein, and monoclonal antibody modalities. Amgen has a well-established and distinguished track record for using green chemistry practices for small molecule medicinal chemistry research and process development. For biologics, we are increasing our study and use of more environmentally friendly processes. We are also pioneering advanced technologies for research and development and manufacturing that are more efficient and use fewer resources.
Highlights of our work in these areas include:
- We calculate E-factor metrics for our small molecules using advanced electronic tools, which help us evaluate the efficiency and environmental performance of the chemical processes used to produce these medicines and help guide our research efforts. We continue to develop a process for life-cycle analysis with the American Chemical Society Green Chemistry Institute Pharmaceutical Roundtable (ACS GCIPR) to holistically evaluate aspects of sustainability such as carbon footprint and energy and water use.
- Amgen’s medicinal chemists met their goal of using less than 15 percent chlorinated solvent in their research for the second year in a row, keeping that usage to only 11 percent. This group held their first annual Medicinal Green Chemistry Awards to recognize outstanding projects from 2015 that exemplify the principles of green chemistry in medicinal chemistry research. One staff member was recognized for optimizing the scale-up of three key compounds for toxicological studies, allowing for a significant reduction in the amount of reagent needed, among other benefits. Another staff member was honored for replacing a two-step sequence with a one-step protocol creating a safer, shorter, higher-yielding, and more benign synthetic sequence.
- We are innovating to produce higher yields using fewer resources with both legacy and new biologic products. Amgen staff within our Process Development organization made outstanding progress in 2015 advancing more sustainable practices in biologics manufacturing. Staff assessed the waste and efficiency profiles for select Amgen therapeutic molecules and monoclonal antibodies. Benchmarking using these tools allows Amgen to measure the environmental benefits realized from our use of Lean manufacturing techniques that eliminate waste and to identify opportunities for continuous improvement.
Technology and Facility Advances
Amgen has pioneered Next-Generation Biomanufacturing technologies that are expected to provide major reductions in carbon emissions, energy consumption, water use, and solid waste compared with conventional biomanufacturing. We plan to use Next-Generation Biomanufacturing for the first time commercially following licensure at our new manufacturing facility in Singapore. Technology used at the facility leverages the dramatic increases in cell productivity our scientists have achieved to allow a facility footprint that is significantly smaller than a conventional plant. The use of disposable technology also eliminates the need to repeatedly clean and sterilize equipment after use, creating tremendous savings for water, energy, and hazardous waste generation.
Amgen is using advanced technologies and facilities for drug product manufacturing that provide tremendous energy conservation benefits.
Industry and Academic Alliances
- Amgen participates actively with the American Chemical Society Green Chemistry Institute (ACS GCI) as part of the Pharmaceutical Roundtable. In 2015, an Amgen scientist, who serves as the co-chair of the roundtable, was featured in a video celebrating the 10-year anniversary of the Roundtable and served as session chair of “The Next Ten Years of Pharmaceutical Green Chemistry” at the 19th Annual Green Chemistry and Engineering Conference.
- Amgen’s executive director of Process Development gave a talk called “Green Chemistry Technology and Culture at Amgen: Innovating for Sustainability During Pharmaceutical Development” at the 250th ACS National Meeting & Exposition in Boston.
- Amgen process development staff contribute to the Biopharma Focus Group, a subgroup of the ACS GCI. The focus group conducted a benchmarking exercise to compile biologics process mass intensity results across the industry using blinded representations of products. The goal of the focus group is to reduce those targets over the long term and to promote best practices throughout the industry. This working group is also sponsoring a grant that encourages academic research into waste reduction and increased efficiency that can benefit industry as a whole.
- A staff member represents Amgen on the ACS GCI Medicinal Chemistry Roundtable.
- An Amgen staff member is the president of the Green Chemistry Group and helped organize SFC China 2015, a conference that showcased best practices and cutting-edge uses for supercritical fluid chromatography.
- Amgen is also a key member of the International Consortium for Innovation and Quality in Pharmaceutical Development’s Green Chemistry Working Group. A highlight this year included a green chemistry short course.
- An Amgen scientist published the paper “Pharmaceutical Green Chemistry at Amgen: Seeing with new Eyes” in Aldrichimica Acta. This staff member was also an author on the paper “It’s Easy Being Green, Cooperative Approaches to Overcoming Regulatory Hurdles” in Innovations in Pharmaceutical Technology.
- A member of our Medicinal Chemistry Green Chemistry team edited a guide for academic and industrial labs to build a green chemistry program called “Green Chemistry Strategies for Drug Discovery” and co-authored a chapter within the guide called “Greener Solvent Usage for Discovery Chemistry Analysis and Purification” with another Amgen staff member.
- Amgen staff members were authors on the paper “Toward Sustainable Engineering Practices in Biologics Manufacturing” with other participants in the Biopharma Focus Group. The paper shares best practices across the industry for the emerging practice of environmental sustainability in biologics manufacturing.