RE: Affimers11 Nov 2025 14:02
5. Phasing in the use of non-animal derived antibodies and affinity reagents
Antibodies are proteins with high specificity for their unique target and have been used as crucial tools for diagnostics, therapeutics, regulatory procedures, and research to investigate molecular and cellular pathways. Antibodies are generated by repeated administration in an animal of an antigen to stimulate the production of antibodies which are then harvested by blood sampling. Large numbers of animals (including rodents, rabbits, goats, sheep and chickens) are used in antibody development and their utility is subject to debate due to issues of specificity and reproducibility. This is especially true for polyclonal-type antibodies (pAbs) which have significant batch to batch variation and often uncharacterised cross reactivities.
Several alternative technologies to traditionally derived antibodies exist, which do not use animals in their production, and which offer unlimited supplies of reagent with limited batch to batch variation. This includes recombinant antibodies (developed using phage display technology), affimers, aptamers and multiclonal antibodies which have all the advantages of pAbs and none of the drawbacks. Adoption of these non-animal alternatives has been limited, within the academic research community, by lack of awareness and education in their utility, commercial availability, and drivers to encourage their use.
In 2021, the ASC made several recommendations with respect to project licence applications proposing the use of animals for pAb production. This included the need to more thoroughly consider whether non-animal alternatives are valid and appropriate before approving future applications.
Target: We will aim to replace the use of animal-derived pAbs by 2030.