6. Do you follow a one assay approach or two assay approach for your neutralizing antibody assays? What are the pros and cons?
Christina Satterwhite: “The one assay approach should be followed for neutralizing antibody (Nab) assays using the same approach as described for the ADA bioanalytical assays. If during method development it is determined that additional assays are required then a multi-assay approach may be necessary i.e. more than one mechanism of action of the drug.”
Arno Kromminga: “The same argument as described previously for the ADA screening assay also holds for NAB assays. One NAB assay should be used as long as it demonstrated that the NAB is able to detect ADA against the biosimilar as well as against the reference product. The biosimilar needs to be used as capture and in cell based NAB assays as stimulating/challenging agent.”
