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EURL ECVAM Recommendation on Non-Animal-Derived Antibodies

Abstract: 

Affinity reagents are binding molecules that have a high specificity for their unique target (antigen). They are crucial tools for research, diagnostics, therapeutic and regulatory applications. Based on their recognition properties and binding specificity, protein-based antibodies are currently still the most important tools for the specific detection of proteins or other molecules. The development and production of monoclonal and polyclonal antibodies as well as other affinity reagents is still involving animals despite the availability of technologies that do not entail the use of animals. In line with the legal requirements of EU Directive 2010/63/EU on the protection of animals used for scientific purposes, animals should not be used in procedures, where a non-animal alternative exists, which provide the same or higher level of information as obtained from animal procedures. For this reason, the EU Reference Laboratory for alternatives to animal testing (EURL ECVAM) mandated its Scientific Advisory Committee (ESAC) to review the available evidence and deliver an opinion on the scientific validity of antibodies and non-antibody affinity reagents produced using animal-free technologies. The review focused on non-animal-derived antibodies generated by phage-display technology since this is the most mature technology and already widely used. Taking into consideration the available evidence, the ESAC endorsed an opinion on the suitability of existing animal-free technologies to produce affinity reagents with equal or better quality (purity, activity, specificity, affinity, stability, reproducibility) than that offered by antibodies produced using the conventional animal-based methods. In addition, ESAC commented on the scientific benefits of using animal-free affinity reagents and assessed whether there are any production and/or application scenarios for which these are not fit-for-purpose and animal-derived antibodies are still indispensable. This science-for-policy report describes the EURL ECVAM recommendations on non-animal-derived antibodies developed on the basis of the ESAC Opinion (Annex 1) and its detailed Working Group Report (Annex 2).