NCad policy advice related to EURL-ECVAM Recommendation on Non-Animal-Derived antibodies
In answer to the request of the Central Authority for Scientific Procedures on Animals (CCD - Centrale Commissie Dierproeven) concerning the recommendation (in the EURL-ECVAM report “Recommendation on Non-Animal-Derived antibodies”, published in May 2020) to end animal use for the development and production of polyclonal and monoclonal antibodies, the NCad drafted her policy advice.
The NCad notes that the EURL-ECVAM report leads the way to the production of antibodies without the use of experimental animals. The NCad expects the development of animal-free antibody production methods to continue and will contribute to a reduction of experimental animal use and the availability of better-defined antibodies for research and therapeutic use. However, the NCad notes that there is concern within the wider scientific community about the general applicability of animal-free methods for the development and production of monoclonal and polyclonal antibodies. For monoclonal antibodies the concerns are centered around the specificity and affinity of the antibodies – both essential for a good antibody. For the polyclonal antibodies the replaceability of these antibodies by a set of monoclonal antibodies (named ‘multiclonals’ in the report) raise concerns next to the amount of work needed to develop such a set of antibodies (time/costs). A complete ban on the use of animals for antibody production, like the report recommends, therefore seems premature. However, the NCad does conclude that a well-founded justification for the use of animals for the production of mono- and polyclonal antibodies will have to be submitted together with the project license application. As appropriate, this justification will be reviewed by experts in monoclonal and polyclonal antibody production.