[HTML][HTML] Optimization and qualification of a functional anti-drug antibody assay for HIV-1 bnAbs
MS Seaman, M Bilska, F Ghantous, A Eaton… - Journal of …, 2020 - Elsevier
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 …
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 …