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Publications / Seaman 2020 (J Immunol Methods)



J Immunol Methods. 2020 Apr; 479(NA):112736.

PubMed ID: 31917969


Optimization and qualification of a functional anti-drug antibody assay for HIV-1 bnAbs


Seaman MS, Bilska M, Ghantous F, Eaton A, LaBranche CC, Greene K, Gao H, Weiner JA, Ackerman ME, Garber DA, Rosenberg YJ, Sarzotti-Kelsoe M, Montefiori DC


The recent identification of human monoclonal antibodies with broad and potent neutralizing activity against HIV-1 (bnAbs) has resulted in substantial efforts to develop these molecules for clinical use in the prevention and treatment of HIV-1 infection. As with any protein therapeutic drug product, it is imperative to have qualified assays that can accurately detect and quantify anti-drug antibodies (ADA) that may develop in patients receiving passive administration of HIV-1 bnAbs. Here, we have optimized and qualified a functional assay to assess the potential of ADA to inhibit the neutralizing function of HIV-1 bnAbs. Using a modified version of the validated TZM-bl HIV-1 neutralization assay, murine anti-idiotype antibodies were utilized to optimize and evaluate parameters of linearity, range, limit of detection, specificity, and precision for measuring inhibitory ADA activity against multiple HIV-1 bnAbs that are in clinical development. We further demonstrate the utility of this assay for detecting naturally occurring ADA responses in non-human primates receiving passive administration of human bnAbs. This functional assay format complements binding-antibody ADA strategies being developed for HIV-1 bnAbs, and when utilized together, will support a multi-tiered approach for ADA testing that is compliant with Good Clinical Laboratory Practice (GCLP) procedures and FDA guidance.

With the publicly available data in the CAVD DataSpace we can Learn about studies, products, assays, antibodies, and publications, Find subjects with common characteristics, Plot assay results across studies and years of research, and Compare monoclonal antibodies and their neutralization curves. Data are also accessible via DataSpaceR, our R API.

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