Advisory letter: EURL-ECVAM Recommendation on Non-Animal-Derived Antibodies

The NCad provided advice to the Central Authority for Scientific Procedures on Animals (CCD) regarding the EURL-ECVAM report titled ‘Recommendation on Non-Animal-Derived antibodies’ published by the European Commission in May 2020. This report recommends discontinuing the use laboratory animals for the development and production of polyclonal and monoclonal antibodies. The CCD asked us to provide additional clarity regarding the interpretation of the report and the resulting impact on the assessment of licence applications in the Netherlands.

We concluded that the EURL-ECVAM report sets a clear direction towards animal-free antibody production. We expect the development of animal-free methods for antibody production to continue and further contribute to the reduction of animal testing, as well as the availability of better-defined antibodies for research and therapeutic use.

However, we also observed ongoing doubts within the scientific community regarding the full applicability of animal-free methods for the development and production of monoclonal and polyclonal antibodies. For monoclonal antibodies, these doubts center on their specificity and affinity, both of which are crucial for ensuring a properly functioning antibody.

For polyclonal antibodies, the doubts concern the substitutability of these antibodies with a set of monoclonal antibodies (called ‘multiclonals’ in the report) and the effort it costs to develop this set of antibodies (in time and money). We therefore believe that a complete ban of the use of laboratory animals for the production of antibodies is premature at this time. However, we advise continuation of the requirement that project proposals must include a detailed justification for the use of laboratory animals for this purpose. Where necessary, such justification can be assessed by competent experts.