Replacement, Reduction and Refinement of Animal Testing in the Quality Control of Human Vaccines
Vaccines are recognised as a highly cost effective tool for preventing infectious diseases. They are derived from biological sources and due to the complexity of composition and heterogeneity of products, vaccine lots undergo legally required quality control before they are released. Traditionally, laboratory animals have played an important role in quality control of vaccines and still, many laboratory animals are used in Europe for this purpose. Over the last decades, Replacement, Reduction and Refinement (3Rs) methods to classical animal tests have been developed by control authorities, academia and vaccine manufacturers.
The purpose of this report is to inform the EURL ECVAM stakeholders on ongoing activities in development and validation of 3Rs methods for the quality control of vaccines for human use. The focus of the report is on methods for lot release testing (e.g. safety, pyrogenicity, potency) and projects related to the implementation of the consistency approach to established vaccines such as diphtheria, tetanus, pertussis and rabies vaccines.
HALDER Maria Elisabeth;
2016-01-19
Publications Office of the European Union
JRC99620
978-92-79-54174-2,
1831-9424,
EUR 27646,
OP LB-NA-27646-EN-N,
https://publications.jrc.ec.europa.eu/repository/handle/JRC99620,
10.2788/582790,
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