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.

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.

Outcomes and 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.

Updates, Related Publications, and Deliverables

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Project Lead

New York State Department of Health (Wadsworth Center)

Participating Organizations

University of Massachusetts System