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 supports biodiversity by reducing the impact on horseshoe crab populations.

Since 2024, Amgen has taken steps to further reduce reliance on horseshoe crabs focused on progressing activities in support of the replacement of compendial LAL endotoxin testing with a recombinant, non-animal derived, option. Specifically, a third-party supplier has deployed a recombinant cascade reagent (rCR) technology that eliminates the use of horseshoe crab derived LAL entirely from its endotoxin testing assays and in 2025 we completed feasibility testing of this technology. Amgen has also completed an internal rCR technology bridging study to assess the equivalence of rCR performance to that of LAL in lab-water testing.

Following publication of final industry standard guidelines on recombinant reagents by U.S. Pharmacopoeia (USP), and supported by positive feasibility and bridging study results, Amgen is now executing on a global validation to enable use of rCR for lab-water testing. As part of this global validation activity, Amgen is piloting the use of rCR at our Amgen Rhode Island (ARI) site to optimize implementation and inform broader deployment. We anticipate that site by site implementation of this technology for lab-water testing will commence after successful ARI adoption.

Amgen is also closely monitoring the European regulatory and pharmacopeial position on the use of rCR and recombinant Factor C (rFc) testing methods. European authorities currently consider rCR to be an alternative method of endotoxin testing that requires full validation and an equivalence assessment to the LAL method. European Medicines Agency has acknowledged the theoretical benefits of rCR technology but indicated that additional data and implementation experience is needed before it can be recognized as a fully equivalent method. Accordingly, implementation of rCR for marketed products in Europe currently appears more complex from a regulatory change-management perspective than implementation of rFC. Given this complexity, Amgen expects to prioritize implementation of rCR at U.S.-governed sites while the European framework for rCR continues to evolve. This approach will still allow Amgen to efficiently reduce LAL use, as the majority of the Company’s manufacturing activities are U.S.-based.

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 rCR 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.