title: Regulatory processes and three Rs alternatives.
abstract: Previously, the role of the laboratory in the regulation of vaccines and other biological products was key to assuring vaccine quality, where tests for potency and safety in animals were used to predict vaccine efficacy and safety in humans. In the past, regulation of inherently variable biological products depended on the use of inherently variable biological tests. Today, the concepts of regulation are evolving. Systems in place to assure product consistency are required; this is reflected in the need to have Good Manufacturing Practice as a part of quality assurance. Regulation now depends more strongly on experience in the clinic, including large post-marketing studies for safety. It also means that laboratory tests, especially in cases where there are no direct correlates of safety and efficacy, are more properly used for confirmation of consistency. In addition, the products themselves have changed. Many biological products can be produced in a form which allows quantification of characteristics, thus allowing more physical tests to be done. Thus, regulation of biological products in future will probably see a replacement, reduction and refinement (the 3 Rs) of animal testing.
authors.affiliation: Department of Vaccines and Biologicals, World Health Organization, Geneva, Switzerland. milstienj@who.int
authors.forename: J
authors.initials: J
authors.lastname: Milstien
mesh_terms: D000826:Animal Testing Alternatives; D000818:Animals; D001688:Biological Products; D019411:Clinical Laboratory Techniques / Q000592:standards*; D006801:Humans; D007753:Laboratories / Q000592:standards*; D011786:Quality Control; D015203:Reproducibility of Results; D014944:World Health Organization
chemical_list: D001688:Biological Products