Open AccessREGEN-COV® antibody cocktail bioanalytical strategy: comparison of LC-MRM-MS and immunoassay methods for drug quantification
Author(s) -
Susan C. Irvin,
Samit Ganguly,
Rachel Weiss,
Chinnasamy Elango,
Xuefei Zhong,
Man Yuan,
Hong Yan,
Ning Li,
Giane Sumner,
Kenneth C. Turner,
John D. Davis,
A. Thomas DiCioccio,
Matthew Andisik,
M. Partridge,
Albert Torri
Publication year - 2021
Publication title -
bioanalysis
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.566
H-Index - 58
eISSN - 1757-6199
pISSN - 1757-6180
DOI - 10.4155/bio-2021-0190
Subject(s) - bioanalysis , chromatography , immunoassay , chemistry , covid-19 , liquid chromatography–mass spectrometry , selected reaction monitoring , mass spectrometry , tandem mass spectrometry , antibody , medicine , virology , immunology , disease , outbreak , infectious disease (medical specialty)
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.