Animal Welfare

Baxter supports the conscientious use of animals in research only when no other acceptable scientific alternative exists to demonstrate the safety and effectiveness of the company's life saving and sustaining products and therapies. Baxter believes that it has an ethical responsibility to ensure the well being and humane care of animals it uses in product development and testing. In the substantial majority of cases where Baxter uses animal testing, it is required by health authorities to do so.

Consistent with Baxter's Bioethics Position Statement, the company is committed to using and developing alternative protocols, methodologies and models which reduce or replace the use of animals. Baxter also works to refine current test systems to improve animal welfare while ensuring sound data. For decades, the company has supported pre-clinical testing involving humane animal use that complies with all relevant local, national and transnational laws and regulations (as verified by regular inspections by the respective authorities/agencies) as well as additional voluntary guidelines.

Veterinary professionals with specialty training operate Baxter's research animal facilities, which are overseen by Animal Care and Use Committees as well as local authorities. These Animal Care and Use Committees review research and testing protocols to ensure that they are appropriately designed, that the information derived is essential and full consideration is given to animal welfare. Baxter's animal research facilities are fully accredited by the Association for the Assessment and Accreditation of Laboratory Animal Care International (AAALAC), which evaluates organizations that use animals in research, teaching or testing. In the United States, the company's facilities are registered and inspected regularly by the U.S. Department of Agriculture (USDA) and are in compliance with Public Health Service Policy as governed by the Office of Laboratory Animal Welfare of the U.S. Department of Health and Human Services. Outside the United States, Baxter's animal facilities and programs are regularly inspected by relevant government agencies and comply with all applicable laws and regulations.

All animals used within Baxter’s research facilities are from sources that Baxter's veterinary professionals select carefully and monitor regularly. Contract research organizations that Baxter uses to assess the safety of its medical products must follow similar animal care and welfare standards, and are reviewed as part of Baxter's overall quality and regulatory compliance program.

Baxter's Global Animal Welfare Committee

Baxter's Global Animal Welfare Committee (GAWC) is composed of internal veterinary professionals and animal scientists whose goals are to enhance current programs and to identify and develop new opportunities to optimize animal welfare. The committee is sponsored by the company's Chief Science and Innovation Officer Norbert G. Riedel, PhD, and oversees standards of animal welfare across Baxter's global operations and contract research organizations including academic institutions.

The GAWC focuses on:

• Further developing and implementing programs that will advance the 3Rs (replace, reduce and refine), and other animal use initiatives;
• Encouraging the identification, investigation and validation of alternative test methods when opportunities exist and regulations permit;
• Setting universal standards of animal care and welfare across all Baxter animal research sites and external collaborators;
• Reviewing Baxter’s animal use, animal welfare programs, and related policies and standards regularly; and
• Updating internal animal welfare education and training programs.

The committee provides ongoing assessment and support of Baxter's animal testing programs to harmonize processes and tools globally. The committee's recommendations are guided by the Association for Assessment and Accreditation of Laboratory Animal Care International's system of program accreditation.

Committee members participate in leading professional organizations where they receive continuing education and share best practices. Examples include:

United States

• Academy of Surgical Research
• American Association for Laboratory Animal Science
• American College of Laboratory Animal Medicine
• American Society of Laboratory Animal Practitioners
• Council on Research for American Veterinary Medical Association

Europe

• The European Partnership for Alternative Approaches to Animal Testing
• Society for Laboratory Animal Science;
• Federation of European Laboratory Animal Science Associations

International

• The Association for Assessment and Accreditation of Laboratory Animal Care International
• The International Association of Bioethics

Replace, Reduce and Refine

Baxter is committed to enhancing animal welfare through the 3Rs - replacement, reduction and refinement. The company applies a range of innovations in this area, including several implemented in 2011 as noted in the lists below.

Replacement

Baxter implements new technologies and processes to substitute animal with non-animal tests.

• For both new product development and established products, Baxter is replacing animal safety testing with cell-based alternative in vitro¹ methods where regulations will allow. In vitro test systems are being validated and registered, which will substantially reduce the use of animals for in-process and final product quality release tests.
• Building upon its expertise in developing cell-based methods of vaccine production, Baxter is using its proprietary cell line system with next-generation production methods which do not require large quantities of fertilized chicken eggs.
• When permitted, Baxter uses cell-based tests to determine the antibody content for specific antibody-based products. For example, for its liquid immune globulin intravenous (IGIV) products that help people with compromised immune systems fight disease, Baxter has replaced animal-based potency testing with a cell-based test, recently approved in the United States.
• Baxter uses thromboelastography (a non-animal, in-vitro test to assess blood clotting) to assess how quickly clots form on new products designed to stop bleeding. This screening test helps to minimize the number of animals needed for efficacy studies.

Reduction

When Baxter is required to conduct animal testing, researchers use enhanced data collection and analysis methods to reduce overall animal use.

• In 2011, Baxter further reduced the number of animals used in quality testing of certain biotherapeutic drugs and vaccines.
• In 2011, Baxter increased the amount of information collected per animal that reduced the number of animals necessary to fulfill specific regulatory requirements.
• When feasible, Baxter uses automated blood sampling techniques and enhanced analytics to ensure high-quality samples every time which reduces animal procedures per study and related animal stress.
• Baxter uses non-invasive, state-of-the-art technologies such as CT scans, fluorescent imaging, advanced ultrasound and fluoroscopy to decrease the need for invasive testing.
• As new testing methods become available, methods must be validated and approved in cooperation with government regulators prior to medical use of the product. Baxter adopts new, approved methods, applies new testing models and thereby reduces animal testing wherever possible. For example, Baxter is investigating strategies to reduce intermediate test steps using the rabbit pyrogen (fever-producing) test, and when possible combines lot runs to minimize the use of control test animals used in a number of product safety and potency tests.
• Baxter uses a combination of animal based toxicology, pharmacology, pharmacokinetics and local irritation tests to minimize animal use, where possible.

Refinement

Baxter researchers work closely with other scientists and industry organizations to share best practices and demonstrate continual improvement. The company also supports organizations that aim to reduce the need for animal testing and promote animal welfare.

• Baxter supports the American Association for Laboratory Animal Science and the American College of Laboratory Animal Medicine to investigate alternatives and refinements to laboratory animal use.
• The company invests in enhanced animal housing to improve comfort and reduce stress.
• Baxter continues to adopt or advance in-vitro techniques to test the efficacy of its products that help stop bleeding in patients in life-threatening situations.
• When possible, the company uses positive reinforcement to condition animals used in studies to enable administration of test materials and collection of blood samples without the use of physical restraint or anesthetics, minimizing stress and improving data quality.
• Baxter evaluates and ensures consistently high standards for all animal housing methods and cage-level enrichments.
• Baxter is exploring using antibody levels in the blood of vaccinated animals as a surrogate marker to evaluate viral-based vaccine potency, instead of measuring the ability to resist infection with a live virus, thereby avoiding the illness stage of the test.
• Baxter adopted new technology with greater detection and quantification of biological parameters to reduce the frequency and volume of samples taken from animals.

1	In-vitro tests are performed on individual cells in a lab environment versus in a living organism