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Aim: In response to the COVID-19 pandemic, Regeneron developed the anti-SARS-CoV-2 monoclonal antibody cocktail, REGEN-COV ®  (RONAPREVE ®  outside the USA). Drug concentration data was important for determination of dose, so a two-part bioanalytical strategy was implemented to ensure the therapy was rapidly available for use. Results &amp; methodology: Initially, a liquid chromatography-multiple reaction monitoring-mass spectrometry (LC-MRM-MS) assay, was used to analyze early-phase study samples. Subsequently, a validated electrochemiluminescence (ECL) immunoassay was implemented for high throughput sample analysis for all samples. A comparison of drug concentration data from the methods was performed which identified strong linear correlations and for Bland-Altman, small bias. In addition, pharmacokinetic data from both methods produced similar profiles and parameters. Discussion &amp; conclusion: This novel bioanalytical strategy successfully supported swift development of a critical targeted therapy during the COVID-19 public health emergency.

Regen-Cov ® Antibody Cocktail Bioanalytical Strategy: Comparison of Lc-Mrm-Ms and Immunoassay Methods for Drug Quantification

Regen-Cov ^® Antibody Cocktail Bioanalytical Strategy: Comparison of Lc-Mrm-Ms and Immunoassay Methods for Drug Quantification