Amgen's Mission & Ethical Use of Animals in Research

Amgen's mission is to serve patients. The safety of the patients that we serve and who take our medicines is of fundamental importance to us. At this time, the use of animals in biomedical research and in the development of novel medicines is indispensable, both for regulatory and scientific reasons. Specifically, we, like all biopharmaceutical companies, are required by the regulations to evaluate the safety and efficacy of new medicines in animals before introducing them into humans for clinical trials. Critical decisions regarding the use of animals in research are made by cross-functional teams of scientific and veterinary experts who balance scientific knowledge and regulatory requirements with considerations of ethical and social values. When we need to use animals in our research programs, we are committed to acting ethically, responsibly, and providing for their health and well-being. 

Statement on Reducing the Use of Horseshoe Crab Derived Materials in Required Endotoxin Testing Assays

Amgen is actively engaged in exploring the development and use of scientifically validated alternative testing methods that are acceptable to regulatory authorities and do not compromise patient safety. As part of these efforts, the Company has focused on reducing its use of endotoxin testing assays that rely on horseshoe crab derived materials to reduce the impact on horseshoe crab populations. Amgen has also documented and published its activities in support of biodiversity more broadly and this policy document can be accessed here. 

Consistent with its adherence to the principles of Reduction, Refinement, and Replacement ("the 3 Rs") in the required use of animal derived products in research, Amgen has been judicious in its use of endotoxin testing, has lowered its usage over time, and has also implemented technology from a third party supplier (Sparing Technology) that reduces the amount of horseshoe crab derived Limulus Amebocyte Lysate (LAL) to 1/20th of the LAL compared to that of traditional endotoxin testing assays. Amgen's use of this Sparing Technology reduces the impact on horseshoe crab populations that supports biodiversity. 

In 2024, Amgen has taken steps related to biodiversity, including steps to reduce horseshoe crab reliance that are focused on progressing activities in support of the replacement of compendial LAL endotoxin testing with a recombinant, non-animal derived, option. Specifically, upon our third-party supplier's deployment of new recombinant factor C technology (rFC technology) that eliminates the use of horseshoe crab derived LAL entirely from its endotoxin testing assays, Amgen promptly commenced feasibility testing of this rFC technology. Also, while awaiting the finalization and endorsement of the U.S. Pharmacopoeia (USP) published industry standard guidelines on the use of rFC technology, Amgen is conducting an internal rFC technology bridging study to determine equivalency of performance of the rFC technology to that of LAL in lab-water testing. Amgen anticipates completing both feasibility testing and bridging studies by the end of fourth quarter 2024.

Based on the anticipated finalization of the USP published industry standard guidelines on rFC by the end of Second Quarter 2025, and assuming positive results from our feasibility testing and bridging studies, Amgen anticipates completion of global validation to enable use of rFC for lab-water testing in 2025 to be in position for the finalization of these USP guidelines and the concurrence of global regulatory authorities. We anticipate site by site implementation of this technology for new product approvals will follow the implementation of rFC for lab-water testing. 

Amgen will continue to publish progress reports on these efforts to reduce its reliance on horseshoe crab derived products, until Amgen has completed the transition to the rFC technology for water technology and for new product approvals.

Accrediting Bodies

Our programs and facilities are subject to unannounced regulatory reviews and inspection by the federal government.  Our corporate standard for animal welfare is compliance with laws and regulations for animal research; specifically compliance with the guidelines of the Guide for the Care and Use of Laboratory Animals ("The Guide"). Additionally, our US programs are accredited by the AAALAC, International and our Canadian programs are accredited by the Canadian Council on Animal Care (CCAC). AAALAC, International and CCAC accreditations are voluntary, peer review assessments and evaluations by private nonprofit organizations that promote the humane treatment of animals in science. AAALAC, International and CCAC accreditation are considered by many the "gold standard" for the care and use of laboratory animals in biomedical research.

3Rs Award Program

In alignment with our commitment to advance the 3Rs, we established an internal 3Rs Award to reward and recognize our employees' progress in this arena. This program was launched in 2011 to support the 3Rs philosophy and is presented annually to the individual or team of scientists that develop new techniques to support one or more of the 3Rs principles. Awards have been given for refinements to a rodent model of bone biology, replacing the use of an animal assay with a non-animal assay for inflammatory diseases, and refinement and reductions in the number of animals used to understand pharmacokinetics and drug metabolism.

A specific example of how we applied the 3Rs was recognized with the 3Rs Award in 2012.  Our dried blood spot (DBS) micro-sampling technique collects and analyses very small volumes (a droplet) of blood or plasma from rodents in pharmacokinetic and drug metabolism studies. DBS makes blood collection less stressful for rodents and translates into refinement and reduction, because less blood is taken from fewer animals to achieve the same scientifically valid results as standard blood collection.

In another example of refinement, we developed and implemented an industry-leading imaging sciences department that utilizes innovative imaging modalities (MRI, CT, PET and Optical) to allow our scientists to view cancers and other diseases in animals in a non-invasive manner while monitoring the long-term effectiveness of new treatments.

Multiple Strategies

We have developed policies, standards and guidelines governing appropriate animal research practices to assure broad, company-wide compliance with all policies and standards for the ethical use of animals in research.  These documents are regularly reviewed to assure they remain current with or exceed the best practices in the industry.

We have a committee of laboratory animal veterinarians, scientists with animal research experience, nonscientists and independent external representative(s) from the local community that are responsible for the oversight of the animal care and use program.  The Institutional Animal Care and Use Committee is charged with discussing, approving and monitoring all Amgen animal research activities.  They accomplish this by reviewing all proposed animal studies, inspecting all internal animal facilities and investigating, if necessary, any animal welfare concern brought forward by employees or the public.  The Committee regularly communicates with and periodically provides status reports to the Institutional Official regarding animal welfare compliance.

Training Programs

Our Code of Conduct requires that our employees and those that conduct animal research on our behalf comply with our Global Laboratory Animal Care and Use Policy. This policy describes our commitment beyond regulatory and accrediting agency compliance and defines the ethical standards, principles and guidelines governing all our animal research and development activities globally. Our Global Laboratory Animal Care and Use Policy mandates that all research involving animals within our corporation or on its behalf be carried out responsibly and humanely, that the principles of the 3Rs (replacement, refinement and reduction) be applied, and that in vivo studies are only conducted when alternative methods are not available to accomplish research goals or regulatory requirements.

High Quality Veterinary Care

Veterinary professionals consult and assist our scientists on animal-related research activities. All our laboratory animals are monitored for signs of health and well-being by trained and qualified laboratory animal science professionals who are certified by the American Association for Laboratory Animal Science or the Canadian Association for Laboratory Animal Science. Employees involved in our laboratory animal organization are required to keep their training and competency up to date and must continually work on developing and refining their skills in working with animals.