Responsible care and use of animals in research

The importance of animal studies in developing the next generation of therapeutics

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We are driven by science, focusing on the discovery and development of the next generation of therapeutics using an array of drug modalities, for example advanced biologics, nucleotide-based therapeutics, and cell therapies. Delivering these innovative new therapies will change the lives of many people around the world. Within R&D, we apply many different methods to develop our medicines, including working with in vitro and in silico methods, animal models, healthy volunteers and patients.

Over the years, progress has been made to reduce the use of animals in medical research, but animal studies remain essential and a requirement for this important work.

We take the responsibility for the ethical care and use of animals in research seriously. Animal welfare is always a priority. At the centre of our commitment to quality science and animal welfare are the Replacement, Reduction and Refinement of animals in research (the 3Rs).

Replacement:

Accelerating the development and use of models and tools, based on the latest science and technologies, to address important scientific questions without the use of animals.

Reduction:

Appropriately designed and analysed animal studies that are robust and reproducible, and truly add to the knowledge base.

Refinement:

Advancing animal welfare by using the latest in vivo technologies and improving understanding of the impact of welfare on scientific outcomes.

Why are animal studies needed?

When discovering and developing new therapies to treat debilitating and serious disease, in many circumstances there are no validated alternatives to animal studies. Studies are conducted for a variety of purposes across a range of illnesses, for instance to find out the most effective dosing patterns for new diabetes treatments, to identify ways of targeting specific types of cancer, or to find the best way of treating patients suffering from lupus. In most cases, animal studies are required by global regulators before they will approve a new medicine to be tested in humans during clinical trials. Animal studies therefore remain essential for evaluating the efficacy and safety of new medicines.

Animal research standards and governance

Our AstraZeneca Council for Science and Animal Welfare (C-SAW) is the expert group leading our global approach to animals in research, promoting the application of the 3Rs, supporting openness about animal use, and providing assurance that we meet our standards. We apply consistent global standards to all work involving animals, whether it is conducted by ourselves or by third parties acting on our behalf.

How do we care for our animals?

We adopt a Culture of Care that goes beyond compliance, to ensure compassion and respect for our animals, which are housed in purpose-built facilities that ensure optimal environmental conditions for all species. Cages and pens are designed so that animals can be kept in socially compatible groups; animals are given a specialised diet for their needs and are supplied with enrichment to allow them to express natural behaviours. All staff working with animals are specially trained in handling and care, to ensure the bond between human and animal is positive.

Culture of Care

Our Culture of Care also includes the research staff who care for our animals. We continually develop this by focusing on:

Creating awareness of everyone’s role and their contribution to science and welfare
Initiatives that support the emotional wellbeing of caregivers
Building better communication and understanding between staff
Ensuring easily accessible mechanisms for reporting concerns

Working towards alternatives to animals in research

We are investing in the continued development of non-animal alternative models, such as advanced cell models, including organoids, “organ-on-chip” microphysiological systems (MPS), as well as use of computer modelling, and Artificial Intelligence (AI) and machine learning driven models. These New Approach Methodologies (NAMs) are used at various stages of the drug discovery process and provide a range of evidence that can help further reduce or, in some instances, remove the need for selected animal studies.

We are actively developing advanced cell models for efficacy and safety assessments:

Human cardiac microtissues that allow us to detect changes in cardiac structure at clinically relevant drug concentrations and provide insights into phenotypic mechanisms.¹
A human kidney MPS, which is capable of mimicking clinically relevant release of kidney injury biomarkers when studying new therapeutics such as antisense oligonucleotides.²
A human bone marrow MPS that allows us to detect compounds that induce micronuclei (a marker of chromosome damage) including those only detected in animals³ and oncology drug-induced cytopenia.⁴ This bone marrow MPS study also presents an illustration of how MPS studies can benefit from a systematic evaluation of confounders to maximise power, efficiency, and scalability.
Multi-organ disease models are also in place for efficacy assessment, such as our linked liver-pancreas MPS for diabetes with associated mathematical modelling for clinical translation.⁵

Cross-industry collaboration on NAMs

We’re working with other pharmaceutical companies to accelerate the adoption of NAMs. For example, we are authors on a recent cross-industry publication⁶ led by the IQ Consortium’s IQ MPS Affiliate, which details the progress and technological advancements needed to increase NAM adoption and decrease the need for animal studies

Our commitment to continuously improving Animal Welfare

Our scientists who work with animals are trained and qualified to a high standard maintained by regular assessment. We also employ expert individuals specifically trained in the monitoring and advancement of animal welfare, including animal welfare officers and veterinarians.

We recognise and celebrate our scientists and animal care staff for exceptional commitment to the 3Rs and our Culture of Care. Our C-SAW Global 3Rs Awards is a competitive and highly visible awards programme that recognises excellence in 3Rs science and encourages continuing improvements in animal welfare across our company and with our external partners.

Winners of our 3R Impact Awards 2023:

Replacement, Reduction, Refinement

Microphysiological Systems

3R Impact Award 2023: Replacing animal experimentation through Microphysiological Systems combined with Modelling. Started in 2019, this project is focused on developing an industry-first quantitative approach using bone marrow modelling as well as supporting five small-molecule projects across 2022. The long-term mission of this project is to increase patient safety whilst reducing the need for animal studies.

Cough Assessment Model

3R Impact Award 2023: Development of a preclinical Method for Spontaneous Cough Assessment. Chronic cough is a troubling symptom for patients with chronic respiratory diseases with an unmet clinical need. This refined model was developed to emulate clinical cough monitoring within small animals improving translatability and reducing the number of animals required in an experiment.

Refined Dosing

3R Impact Award 2023: Optimising Oestrogen Delivery in Mice. Oestrogen supplementation is essential for the growth of and assessment of human tumours in mouse xenograft models. Supplementing oestrogen in small animals is complex, so this project focused on refining dosing methods to improve animal welfare.

FAQs: Animal research at AstraZeneca

How many animals are used in our research?

Globally, animals were needed for in-house studies 122,768 times in 2023, and on our behalf in contract research studies 59,690 times. In total, over 97% were rodents or fish, the vast majority being mice (84%); the remainder is made up of rabbits, camelids, ferrets, dogs, pigs, non-human primates, chickens and sheep. Dogs and non-human primates make up less than 1% of the total.

The total number of animals each year varies because use depends on several factors, including the amount of pre-clinical research we are doing, the complexity of the diseases and medicines under investigation, and regulatory requirements. Our 3Rs approach ensures we are using the right number of animals to deliver a statistically reliable result, and to avoid repeating studies unnecessarily.

In 2023, over 97% of animals used in our in-house studies and on our behalf in contract research studies were rodents or fish, the vast majority being mice (84%). Mice have a critical role in the research and development of treatments for cancer and other devastating diseases. Advances in technologies to genetically alter mice that model human disease have significantly reduced the time it takes to develop new medicines. Registration of new medicines also requires an environmental assessment, because once pharmaceuticals are used, traces of them can be found in the environment. These environmental assessments include studies with zebrafish, which are also used in a variety of research studies in the early discovery of new therapeutics.

Dogs and non-human primates made up less than 1% of the total. Some regulatory approvals of new medicines require that they are evaluated for human safety in two mammal species, typically a rodent and a larger non-rodent species such as a minipig, dog or non-human primate. Minipigs are sometimes not suitable due to a specific drug interaction that can only be avoided by using dogs instead; non-human primates are needed only when other species cannot replicate aspects of human biology with the same degree of accuracy. In all cases clear ethical justification must be made for species selection.

All research animals are purpose bred by licenced and regulated breeders. Pets and stray animals are not used for research, and we do not conduct research using wild-caught non-human primates or great-ape species. Animal breeders and vendors are included in our animal welfare assurance programme.

We are a signatory to the Concordat on Openness in Animal Research in the UK. Launched in July 2014, it commits us and other signatories to being clear about when, how, and why we use animals in research; enhancing our communications with the media and the public about our research using animals; and reporting annually on our progress. We also have similar commitments in other parts of the world including the Openness Agreement on Animal Research and Teaching (Australia/New Zealand) and we are contributing to the U.S. Animal Research Openness Initiative.