Ensuring the welfare of animals in our research
Why are animals used in research?
Almost every major medical advance of the last century has depended on research involving animals, helping scientists to understand diseases and develop new medicines - from vaccines to cancer treatments.
“Today, we rely on the use of animals in many cases, for example, to ensure that our medicines are safe and effective. As long as this is necessary, we have two undeniable obligations. One is to invest in finding better alternatives to the use of animals, and the other is to maximize the quality of life of all animals we use,” says Kerstin Kleinschmidt-Doerr, our Chief Veterinary Officer and Head of Corporate Animal Affairs.
"We don't conduct animal studies because we like to or because it would save us time or money. In fact, we hate them," says Danny Bar-Zohar, Head of our global Healthcare R&D. "The positive predictive value of animal testing is limited. That's why I'm convinced by technological advances such as simulating the patient on a chip. But convincing physicians that you can do a clinical trial on their patients based on data coming from a chip, is not something we will be able to achieve overnight."
The COVID-19 pandemic was a striking example of the critical role that animal research has traditionally played in driving forward medical breakthroughs for the benefit of people around the world. This research was conducted all over the world, including in 24 European countries. 
“Without animal testing, it would not have been possible to deliver much-needed vaccines in record time,” explains Kleinschmidt-Doerr. “But we firmly believe that the development of alternative methods and technologies, such as human-on-a-chip and artificial intelligence (AI), will enable scientists to make similar advancements in the future without the use of animals.”
Historically, regulatory agencies such as the US Food and Drug Administration (FDA) have stipulated a strict requirement for animal testing on any new drugs and medical devices before trials in people can take place. But there are early indications suggesting this may change soon. In September 2022, the US Senate passed a bill to end the mandate to test new drugs on animals. If enacted, this legislation would update existing FDA regulations to allow drug developers to use new human-relevant testing methods to replace animal experiments – importantly, as long as it does not compromise patient safety.
“Although it’s still early days, this is a fundamental step forward – offering the hope of greater flexibility in this area in the future,” says Kleinschmidt-Doerr. “It provides additional impetus for us to increase our efforts to develop and validate animal-free solutions for use in medical research.”
Today, national and international laws and regulations also require the testing of chemical substances in animals to protect consumers, workers, and the environment from the potentially harmful effects of chemicals used in a huge variety of everyday products – from paints and dyes to household cleaners and food additives. We and others are also working hard to develop and receive approval for the use of alternative methods in this area.
Did you know?
European countries conducted animal research as part of the global fight against COVID-19. 
was when the 3Rs principles were developed as a framework for animal research. 
represent our unique approach to animal welfare.
From 3Rs to 4Rs
For our company, animal research and testing are required to verify the safety of our medicinal and chemical products and the effectiveness of our pharmaceuticals. We also use animals in our life science business, for example, to generate substances – such as growth factors – essential for cell culture methods, or to produce antibodies for research and diagnostics.
But we use animals in our work only where it is necessary and there is no available alternative. Where possible, we also strive to develop and use better animal-free alternatives across all areas of our business and to convince others to make the switch too. We enforce stringent animal welfare standards that meet and often exceed applicable laws.
“We always use as few animals as possible and replace their use whenever feasible with alternative methods,” says Frederic Christian Pipp, our Global Animal Welfare Officer for the EMEA/APAC region. “We accept our responsibility for all animals we use – and we continuously improve our animal testing processes, striving to enhance the animals’ quality of life.”
We subscribe to the internationally recognized 3Rs principles , which were developed in 1959 as a framework for animal research. These were set up to help researchers to replace animal studies and, where this is not possible, reduce the number of animals used and refine these to minimize distress or discomfort before, during, and after testing.
Sixty years later, philosophers David DeGrazia and Tom Beauchamp published their six principles of animal research ethics.  These principles go a lot further than the 3Rs, especially in that they consider the responsibility for the well-being and quality of life of the individual animal and its species-specific basic needs. Our company has adopted these ethical principles as our fourth R – responsibility – where we accept the responsibility for all animals in our reach, both internally and among our external collaborators.
“All our employees along our value chains contribute to maximizing the benefits that our company achieves through the use of animals. Therefore, we all bear the ‘responsibility’ for these animals,” says Danielle Elbirt, our Global Animal Welfare Officer for the NA/SCA/Israel region. “It also demonstrates our appreciation of all employees who are directly responsible for the welfare of our animals every day.”
Many of the new ideas for improving our animal welfare work are proactively initiated by our researchers. As a company, we are extremely proud of what they are achieving and its impact. That’s why we honor them with our 4R Awards in a two-year cycle.
“This year, the 4R grand prize – which included prize money of 10,000 euros – was equally divided, as both winning teams promoted phasing out animal testing while creating value with innovative better methods,” says Elbirt.
The individual 2022 prize winners were:
- Sarah Sheridan won the REDUCTION category with her project to eliminate the use of guinea pigs for adventitious agents testing.
- Janmeet Anant and Monica Cardona won the REPLACEMENT category for their efforts to push for in vitro cytotoxicity testing to replace animal testing.
- Matthias Kamper won the REFINEMENT category Award for the creative development of a large group housing system for mice that significantly improves their quality of life.
- Stephanie Menges showed us how all our employees can have a significant impact on animal welfare and was awarded the RESPONSIBILITY trophy.
While we perform the majority of animal studies ourselves, procuring the required animals from specialized breeders, we do sometimes commission contract research organizations (CROs) or partner with universities to conduct animal studies on our behalf. This is sometimes the best choice as they may have particular expertise or animal models that we don’t have access to ourselves. Regardless of whether animals are used internally in our facilities, or on our behalf by and at other organizations or institutions, we have the same high standards for husbandry, care, and operation.
“There are different regulatory standards that stipulate living conditions – including lighting, temperature, relative humidity – that need to be followed in different parts of the world,” says Manja Friese-Hamim, Head of Animal Using Vendor and Vivarium Management. “No matter where the work is carried out, we require our partners to adhere to EU regulations, which are the strictest in the world. This is how we try to raise the quality of animal testing and ensure that all work carried out on our behalf adheres to the very highest standards.”
Developing alternative systems
Our long-term ambition is to phase-out animal use in our work. To achieve this goal, we’re using the latest advances in technology to create and apply viable animal-free alternatives. In addition to being more ethical and sustainable, we believe that animal-free solutions can also deliver superior performance.
Any parenteral pharmaceutical products (which enter the body by routes other than the mouth) – such as drugs, dialysis solutions, and medical devices – are required to undergo mandatory safety testing to confirm the absence of pyrogens. These are substances, such as bacterial endotoxins and chemicals, which can cause life-threatening fever reactions.
“In the past, testing for pyrogens was carried out using rabbits,” says Pipp. “We have since developed the PyroMATTM assay, which provides an in vitro alternative to conventional rabbit testing for the assessment of pyrogenicity in accordance with regulatory guidelines.”
The PyroMATTM assay now replaces animal-based methods in international guidelines.
By applying recombinant genetic engineering technologies, we have also developed a new generation of antibodies for use in research that can be manufactured in cells without the need to use any animals. Our scientists are also working on ‘organ-on-a-chip’ technology – and, together with researchers at the Weizmann Institute of Science, ‘human-on-a-chip’ technology’ – advanced cell culture platforms that could ultimately deliver powerful non-animal alternatives for drug testing. And our new 3D cell model that mimics the early stages of malaria is accelerating the search for drugs that can prevent the disease and drastically reducing the use of animals in research.
Another of our projects aims to phase out the use of fetal bovine serum (FBS), not only in our R&D business but also across the whole life science industry. This nutrient-rich fluid, which is derived from the blood of bovine fetuses as a by-product of the dairy industry, contains an undefined and highly variable cocktail of most of the nutrients, growth factors, antibodies, and hormones required to promote the growth of cultured human and animal cells. It is widely used in cell culture applications by academic and industrial researchers – and still for the manufacturing of many biological products made in cells, such as vaccines or therapeutic antibodies.
“Researchers from our life sciences business are working with colleagues in our healthcare business to develop synthetic alternatives,” says Pipp. “By doing so, we leverage the best of all worlds in our science and technology corporation to develop ways to grow cells without FBS – either using a step-by-step approach to adapt to serum-free conditions or using non-animal derived growth supplements.”
Shaping the future
We work with the relevant authorities to challenge the status quo and implement changes to existing regulations – such as ensuring that animal-free alternatives are officially recognized and adopted at an international level.
“For example, EU regulatory authorities approved an alternative method that does not involve guinea pigs for testing some of the plastic parts in medical pumps,” says Pipp. “While the animal-based test is not forbidden, it is now no longer specified as a requirement in the regulation for this medical device.”
We are leading the way to create superior alternatives that can phase out the global use of animals during scientific research, product development, testing, and manufacturing.
“Unfortunately, it is still necessary to do certain animal tests – but we are committed to performing these in the best way possible and only where it’s absolutely required,” says Joachim Coenen, one of our Corporate Animal Welfare Officers. “And we’re also working extremely hard to phase out animal studies wherever possible and replace them with better alternatives.”
As a leading global science and technology company, we are committed to ensuring that all our animal research is ethical, responsible, and humane. We want to be the preferred choice for customers and partners that care about animal welfare and want to act more sustainably by embracing the 4Rs. We have made it a priority to become the go-to place for everybody who cares about animal welfare, accepting only the highest animal ethics and standards until we achieve our long-term ultimate ambition: to entirely phase-out animal use.
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