Alternatives to Animals in the Development and Control of Biological Products for Human and Veterinary Use
Congress London, September 1998. "Developments in Biological Standardization", Vol 101.
Published in 1999
Book
Paperback/Softback
XII, 340 pages
978-3-8055-6953-8 (ISBN)
Description
Interest in the use of alternative in vitro reduction and refinement methods in the development and control of biological products has increased considerably in the last few years. The issues raised are of concern to the scientific community as well as to manufacturers, regulatory authorities and those involved in animal ethics and welfare. A large number of physicochemical, immunochemical, biochemical and cell biological methods have been proposed for the replacement, reduction and refining of animal tests in the development and control of human and veterinary vaccines and other biological products. However, the implementation, validation and ultimate regulatory acceptance of these procedures are still at a very early stage. This volume contains the proceedings of a meeting, which brought together research scientists, manufacturers and regulators with the aim of promoting an exchange of scientific knowledge and increasing awareness of the importance of validation studies.
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Content
Part 1 Vaccines, animals and man: developments in the reduction, refinement and replacement of animal tests in the quality control of immunobiologicals. Part 2 Current regulations and regulatory policy on alternatives: CBER - new approaches to biological product testing; requirement to consider alternatives in the United States; alternatives to animals in the development and control of biological products for human and veterinary use - the role of the European pharmacopoeia. Part 3 Alternatives to in vivo immunogenicity tests and antibody production: synthetic peptide vaccines - foot-and-mouth disease virus as a model; antibody production without animals; use of animal testing for evaluating glycoconjugate vaccine immunogenicity; membrane-based cell culture systems - an alternative to in vivo production of monoclonal antibodies. Part 4 Alternatives to in vivo potency and protection tests: alternatives to in vivo potency and protection tests for veterinary vaccines; viral veterinary vaccines; poultry vaccines - an analysis of the animal trials required for vaccine testing and the way to reduce or refine these tests; development of monoclonal antibodies suitable for use in antigen quantification potency tests for clostridial veterinary vaccines; development of a nitric oxide induction assay as a potential replacement for the intercerebral mouse protection test for potency assay of pertussis whole cell vaccines; evaluation of toxin neutralization in test systems for diphtheria antibody assessment; potency testing of anti-lymphocyte globulins - in vitro alternatives for the monkey skin graft assay. Part 5 Alternatives to in vivo toxicity and safety tests: a 4R concept for the safety testing of immunobiologicals; neurovirulence; detection of endotoxins and other pyrogens using human whole blood; novel assays for the detection of botulinum toxins in foods; toxicity tests on native and recombinant Bordetella pertussis adenylate cyclase toxin preparations. Part 6 Physicochemical alternatives to bioassays: hormones - the role of the European pharmacopoeia; the development of non-animal based bioassays for cytokines and growth factors; new methods for the characterization of biopharmaceuticals - conjugate vaccines against Haemophilus influenzae type b. Part 7 Reduction and refinement of in vivo tests: refinement of in vivo tests; reduction in animal use in the production and testing of biologicals. Part 8 Validation, acceptance and global harmonization of alternative methods: alternatives and developing countries; the use of alternatives to animal tests in developing countries. Part 9 Case reports and collaborative studies: validation of test methods in the quality control biologicals; use of the single dilution test for the EP tetanus toxoid potency assay; tetanus antibodies measured by the toxin binding inhibition test (ToBI) in mothers and children in the neonatal tetanus program in Vietnam. (Part contents)