Spike Identification Nanobody Panel for SARS-CoV-2 Vaccine Manufacturing
The goal of the 12-month NIIMBL project is to generate a panel of RBD-specific antibodies (“nanobodies”) that can be used for identity tests in the manufacture of SARS-CoV-2 subunit vaccines.
Categories
Assays
Process control
Active Immunization Countermeasures
Industry Need
From the perspective of Chemistry, Manufacturing, and Controls (CMC), COVID-19 vaccines face challenges due to the large number of SARS-CoV-2 variants of concern (VoCs) that have emerged.
Specifically, reagents for analytical assays must discriminate among the closely related vaccine antigens like recombinant receptor-binding domain (RBD) subunits.
Solution
MassBiologics and the Wadsworth Center teamed up to generate a panel of RBD-specific antibodies (“nanobodies” or VHHs) that can be used for identity tests in the manufacture of SARS-CoV-2 subunit vaccines.
MassBiologics used yeast-display technologies to identify nanobodies specific for each RBD VoC, while Wadsworth Center evaluated the nanobodies’ suitability to function in mock identity tests with drug substances and drug products.
Outputs/Deliverables
• GLP-grade quality SARS-CoV-2 RBD protein antigens from wild type, Beta, Delta, and Omicron variants were produced and purified at milligram quantities.
• A panel of VoC-specific VHH-IgG antibodies against SARS-CoV-2 RBD spike protein were identified and characterized for binding affinity (ELISA, BLI), SARS-CoV-2 neutralization, and epitope class.
• Developed SOPs for RBD and RBD adsorbed binding assays
Impacts
MassBiologics and the Wadsworth Center developed critical reagents for use in developing analytical CMC assays involved in the manufacturing of SARS-CoV-2 subunit vaccines, which can help accelerate the manufacturing process.
Publications
Additional Project Information (Members Only)
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