Replacement, Reduction and Refinement in the Production and Quality Control of Immunobiologicals

Abstract

This review paper will discuss some of the opportunities for three Rs approaches in the production and quality control of immunobiologicals. Major products in terms of animal use are the polyclonal antibodies(Pab), monoclonal antibodies (Mab) and vaccines. These categories of products are also characterized by the high percentage of experimental procedures that involve substantial pain and suffering to the animals. Nowadays a wide range of approaches and test methods are available that are able to substantially refine, reduce and replace animal use. These include for instance the use of humane endpoints, replacement of challenge procedures in vaccine potency testing by serological approaches or the replacement of ascites production in Mab production by in vitro techniques. Although total replacement of animals for production and quality control of immunobiologicals will not be possible within the near future, it is concluded that substantial three R's progress can be made quite easily without the need for exorbitant human and financial resources.