Co-formulation of broadly neutralizing antibodies 3BNC117 and PGT121:Analytical challenges during pre-formulation characterization and storage stability studies
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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Ashaben Patel, Vineet Gupta, John M. Hickey, Nancy S. Nightlinger, Richard S. Rogers, Christine Siska, Sangeeta B. Joshi, Bruce A. Kerwin, and David B. Volkin, "Co-formulation of broadly neutralizing antibodies 3BNC117 and PGT121:Analytical challenges during pre-formulation characterization and storage stability studies" in "Vaccine Technology VII", Amine Kamen, McGill University Tarit Mukhopadhyay, University College London Nathalie Garcon, Bioaster Charles Lutsch, Sanofi Pasteur Eds, ECI Symposium Series, (2018). http://dc.engconfintl.org/vt_vii/1