Publication of Interest: Neutralizing Antibody Validation Testing and Reporting Harmonization

Experts from the AAPS's Therapeutic Product Immunogenicity Community and the Food and Drug Administration (FDA) recently published an open access article on "Neutralizing Antibody Validation Testing and Reporting Harmonization" in the AAPS Journal. This industry-Agency collaboration helps align the science and data needed for regulatory review of immunogenicity data.

 

The Abstract notes the areas required to be tested during validation and included in the validation reports:

(1) format selection;

(2) cut point;

(3) assay acceptance criteria;

(4) control precision;

(5) sensitivity including positive control selection and performance tracking;

(6) negative control selection;

(7) selectivity/specificity including matrix interference, hemolysis, lipemia, bilirubin, concomitant medications, and structurally similar analytes;

(8) drug tolerance;

(9) target tolerance;

(10) sample stability; and

(11) assay robustness

 

Kudos to Heather Myler and the team for the in-depth consideration of the issues related to NAb assays and in developing recommendations for standardized reporting formats.