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Comparative Assessment of the Binding and Neutralisation Activity of Bispecific Antibodies Against SARS-CoV-2 Variants.
Dean, Alexis Q; Stauft, Charles B; Twomey, Julianne D; Tan, Joshua; Varani, Luca; Wang, Tony T; Zhang, Baolin.
  • Dean AQ; Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, USA.
  • Stauft CB; Laboratory of Vector-Borne Viral Diseases, Division of Viral Products, Office of Vaccine Research and Review, Food and Drug Administration, White Oak, MD 20993, USA.
  • Twomey JD; Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, USA.
  • Tan J; Antibody Biology Unit, Laboratory of Immunogenetics, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rockville, MD 20852, USA.
  • Varani L; Institute for Research in Biomedicine, University of Switzerland, CH-1015 Lausanne, Switzerland.
  • Wang TT; Laboratory of Vector-Borne Viral Diseases, Division of Viral Products, Office of Vaccine Research and Review, Food and Drug Administration, White Oak, MD 20993, USA.
  • Zhang B; Office of Biotechnology Products, Center for Drug Evaluation and Research, Food and Drug Administration, Silver Spring, MD 20993, USA.
Antib Ther ; 6(1): 49-58, 2023 Jan.
Article in English | MEDLINE | ID: covidwho-2212700
ABSTRACT

Background:

Neutralising antibodies against SARS-CoV-2 are a vital component in the fight against COVID-19 pandemic, having the potential of both therapeutic and prophylactic applications. Bispecific antibodies (BsAbs) against SARS-CoV-2 are particularly promising, given their ability to bind simultaneously to two distinct sites of the receptor-binding domain (RBD) of the viral spike protein. Such antibodies are complex molecules associated with multi-faceted mechanisms of action that require appropriate bioassays to ensure product quality and manufacturing consistency.

Methods:

We developed procedures for biolayer interferometry (BLI) and a cell-based virus neutralisation assay, the focus reduction neutralisation test (FRNT). Using both assays, we tested a panel of five BsAbs against different spike variants (Ancestral, Delta and Omicron) to evaluate the use of these analytical methods in assessing binding and neutralisation activities of anti-SARS-CoV-2 therapeutics.

Results:

We found comparable trends between BLI-derived binding affinity and FRNT-based virus neutralisation activity. Antibodies that displayed high binding affinity against a variant were often followed by potent neutralisation at lower concentrations, whereas those with low binding affinity also demonstrated reduced neutralisation activity.

Conclusion:

The results support the utility of BLI and FRNT assays in measuring variant-specific binding and virus neutralisation activity of anti-SARS-CoV-2 antibodies.
Keywords

Full text: Available Collection: International databases Database: MEDLINE Type of study: Experimental Studies Topics: Variants Language: English Journal: Antib Ther Year: 2023 Document Type: Article Affiliation country: Abt

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Full text: Available Collection: International databases Database: MEDLINE Type of study: Experimental Studies Topics: Variants Language: English Journal: Antib Ther Year: 2023 Document Type: Article Affiliation country: Abt