Co-formulation of broadly neutralizing antibodies 3BNC117 and PGT121:Analytical challenges during pre-formulation characterization and storage stability studies

Conference Dates

June 17-22, 2018


In this study, we investigated analytical challenges associated with the formulation of two broadly neutralizing anti-HIV monoclonal antibodies (bnAbs), 3BNC117 and PGT121, both separately at 100 mg/mL and together at 50 mg/mL each. The bnAb formulations were characterized for relative solubility and conformational stability followed by accelerated and real-time stability studies. While the bnAbs were stable during 4°C storage, incubation at 40°C differentiated their stability profiles. Specific concentration dependent aggregation rates at 30°C and 40°C were measured by size exclusion chromatography for the individual bnAbs with the mixture showing intermediate behavior.

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