By Susan C. Irvin, Kyra J. Cowan, Michele Gunsior, and Robin Marsden
Recently, a cross-industry team of experts was brought together to harmonize how NAb results are presented in bioanalytical reports (BARs). NAb assessments are used to characterize a confirmed positive anti-drug antibody (ADA) response.
Harmonization of bioanalytical reporting of NAb assay performance and results enables efficient communication and expedient review by industry and health authorities.
This cross-industry group established harmonized NAb assay reporting recommendations and provided a bioanalytical report (BAR) submission template developed to facilitate agency filings; these documents will be available for reference in a forthcoming publication (Jani, et al. Neutralizing Antibody Sample Testing and Report Harmonization. AAPS J. 2024).
As part of the development of this manuscript and report template, this team evaluated current industry practices and regulatory expectations, and via AAPS, conducted an industry-wide survey requesting feedback on the reporting of NAb results. These survey results are provided in this communication.
The views expressed in this manuscript are collective views of the authors and are not to be ascribed to the authors’ employers.
Editorial support, funded by Regeneron Pharmaceuticals, Inc., and under the direction of the authors was provided by Alpha (a division of Prime, Knutsford, UK), according to Good Publication Practice guidelines.