Abstract
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 & 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 & conclusion: This novel bioanalytical strategy successfully supported swift development of a critical targeted therapy during the COVID-19 public health emergency.
Keywords: Bland-Altman; SARS-CoV-2; bioanalytical; drug concentration assay; monoclonal antibody therapeutic.
【저자키워드】 SARS-CoV-2, Bland-Altman, bioanalytical, drug concentration assay, monoclonal antibody therapeutic., 【초록키워드】 COVID-19, therapy, COVID-19 pandemic, monoclonal antibody, drug, anti-SARS-CoV-2, immunoassay, REGEN-COV, therapeutic, public health emergency, USA, correlation, targeted therapy, Critical, parameters, ECL, Concentration, Analysis, dose, profile, pharmacokinetic data, Regeneron, Result, produced, was used, addition, linear, was performed, supported, Initially, 【제목키워드】 immunoassay, antibody cocktail, REGEN-COV, quantification,