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FDA Awards Kemp Proteins Contract to Develop Monoclonal Antibodies for SARS-CoV-2 and Influenza Vaccine Potency Assays
17 October 2022, Frederick, Maryland — Kemp Proteins announced today that it had been selected by the United States Food and Drug Administration (FDA) to develop monoclonal antibodies to SARS-CoV-2 and Influenza molecules. The FDA’s Laboratory of DNA Viruses (FDA/LDV) will use the antibodies developed by Kemp Proteins in the design of in-vitro assays for potency release of SARS-CoV-2 and Influenza vaccines.
Specifically for SARS-CoV-2 virus, there is a need for a deeper understanding of how the human body mounts an immune response to the virus. FDA/LDV is interested in developing monoclonal antibodies against the Spike protein receptor-binding domain for binding and competition assays that will use immune sera. Kemp Proteins will apply its custom antibody development technology to generate type-specific antibodies for SARS-CoV-2 targets for the FDA. Michael Keefe, CEO of Kemp Proteins, said “we are excited to have been selected and to be working with the FDA, to develop these important antibodies. We are looking forward to growing this working relationship with the FDA’s Laboratory of DNA Viruses.”
Additional to potency release assays, the FDA/LDV is investigating in-vitro binding and competition assays to evaluate the immune response to SARS-CoV-2 and influenza vaccines. Current influenza vaccine potency assays require a strain-specific antigen standard and a strain-specific antibody standard. These standards are made for each new strain included in the annual vaccines. The FDA will streamline the process by developing monoclonal antibodies that are type-specific rather than strain specific, so they can be more broadly used to assay the potency of all vaccine strains for influenza subtype.
About the Contract
The contract 75F40122P00547 “Monoclonal Antibody Production” is 100% supported with federal funds provided by the United States Food and Drug Administration (FDA). The content of this press release does not necessarily reflect the views or policies of the FDA, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. government.
About Kemp Proteins (www.kempproteins.com)
Kemp Proteins LLC, a Six.02 Bioservices member company, is a leading provider of gene-to-protein, hybridoma, and cell line development services. Kemp’s team of experienced protein problem-solvers deliver best-in-class services that optimize productivity and mitigate risk for life sciences innovators developing protein-based products, including human and veterinary diagnostics, biopharmaceuticals, and vaccines. Kemp Proteins operates under a Quality Management System certified against ISO9001:2015 and ISO 13485:2016 standards.
