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 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. The other cases primarily relate to new product discovery, research and development.

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 more than 20 years, 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 animal facilities, which are overseen by animal care and use committees as well as local authorities. These teams of veterinary professionals review research and testing protocols, approve those that are appropriately designed, ensure animal welfare and guarantee that the information derived is essential.

All animals used by Baxter 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 comprised 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 Scientific 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 welfare program, policies, standards and best practices regularly;
• Updating internal animal welfare education and training programs; and
• Setting strategic direction for future activities.

The committee provides ongoing assessment and support of Baxter's animal testing programs to harmonize processes and tools globally and to share best practices. 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

• American Association for Laboratory Animal Science;
• American College of Laboratory Animal Medicine;
• American Society of Laboratory Animal Practitioners; and
• Council on Research for American Veterinary Medical Association.

Europe

• The European Partnership to Alternative Approaches to Animal Testing; and
• Federation of European Laboratory Animal Science Associations.

International

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

Replace, Reduce and Refine

Baxter is committed to enhancing animal welfare through the 3Rs - replacement, reduction and refinement. During recent years, Baxter has applied innovations including the following:

Replacement

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

• Continue to replace or eliminate animal research in three products by using in-vitro¹ tests on individual cells. This includes replacing the rabbit pyrogen test (used to assess the potential for adverse events in humans) with the non-animal Limulus Amebocyte Lysate test in more than a dozen production steps.
• Building upon its expertise in developing cell-based methods of vaccine production, Baxter is using its propriety 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, minimizing 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.

• When feasible, Baxter uses automated blood sampling techniques and enhanced analytics to ensure high-quality samples every time and reduce the number of needle sticks 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, in cooperation with government regulators, methods must be validated and approved 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 testing 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 viral vaccine potency testing.

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 critical, life-threatening situations.
• When possible, the company uses positive reinforcement conditioning of pigs 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.
• Using a company-wide process, Baxter evaluates and ensures consistently high standards for all rodent and rabbit housing methods and cage-level enrichments
• Baxter is investigating using analgesics to limit discomfort in tests that evaluate the safety of materials used in medical devices.
• 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.

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