What are the safety considerations when sourcing bovine (bovine) or porcine (porcine) materials for medical use?

Safety Considerations for Sourcing Bovine and Porcine Materials for Medical Use

When sourcing bovine or porcine materials for medical use, strict adherence to FDA guidelines regarding screening for transmissible diseases, proper processing protocols, and quality control measures is essential to minimize infectious disease risks to patients. 1

Regulatory Framework

• The FDA has established comprehensive guidance documents specifically addressing bovine-derived materials, including specific letters to manufacturers of FDA-regulated products (August 29,1994) 1
• Medical products derived from animal sources are regulated under multiple federal laws, including the Public Health Service Act, the Federal Food, Drug, and Cosmetic Act, and the Animal Welfare Act 1
• The FDA's Center for Biologics Evaluation and Research (CBER) recommends that serum used to produce biologicals be obtained from sources certified to be free from contaminants and adventitious agents, particularly those responsible for transmissible spongiform encephalopathies 2

Bovine-Specific Considerations

• Since 1993, the FDA has requested that bovine-derived materials from animals born in or residing in countries where bovine spongiform encephalopathy (BSE) has occurred should not be used in products intended for humans 2
• The FDA has reopened comment periods for interim final rules regarding the use of cattle materials in human products to address new scientific findings about BSE infectivity in various parts of bovine intestines 3
• Special attention must be paid to sourcing bovine serum, as studies of BSE have been limited in size and sensitivity, and some experimental studies have found infectivity in tissues previously thought to be safe 2
• Considering the widespread use of biological products, especially vaccines intended for children, U.S. regulatory authorities maintain conservative policies regarding bovine materials from countries with BSE 2

Porcine-Specific Considerations

• Porcine materials used in medical products must be screened for viral agents including foot and mouth disease, classical swine fever, African swine fever, and swine vesicular disease viruses 4
• Biological meshes of porcine origin (such as Strattice, Permacol, Fortiva, Surgisis, and Xenmatrix) are available on the market for various medical applications but require careful sourcing and processing 1
• Risk assessment is necessary to determine the safety of importing porcine materials from zones where these diseases may be present 4
• Processing methods must be validated to ensure viral inactivation, with consideration for pH and temperature lability of potential contaminants 4

General Safety Protocols

• The FDA has published guidance documents for the characterization of cell lines used to produce biologicals and the viral safety evaluation of biotechnology products derived from cell lines of human or animal origin 1
• Xenotransplantation (the use of living animal cells, tissues or organs in humans) presents unique infectious disease concerns that require specialized screening and monitoring protocols 1
• The Centers for Disease Control and Prevention advises avoiding cross-contamination when handling animal-derived materials by washing hands, utensils, and surfaces after contact 5
• Proper storage and handling of animal-derived materials is essential to prevent contamination and maintain product integrity 5

Cultural and Religious Considerations

• Muslim and Jewish individuals may have religious concerns regarding the use of porcine-derived medical products, though religious rulings generally permit such use for life-saving purposes 6
• Healthcare providers should be aware that many patients may not be knowledgeable about religious exemptions for medical use of otherwise prohibited materials 6
• Informed consent processes should include clear information about the source of animal-derived materials used in medical products 6

Quality Control and Testing

• Manufacturers must implement rigorous quality control measures, including testing for adventitious agents and validation of purification processes 1
• Bovine and porcine materials should be sourced from animals with documented health status and appropriate veterinary oversight 1
• Processing methods should be validated to ensure removal or inactivation of potential pathogens while maintaining the desired biological properties of the material 1