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

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 ra...

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Bibliographic Details
Main Authors: Andisik, M.D (Author), Davis, J.D (Author), Dicioccio, A.T (Author), Elango, C. (Author), Ganguly, S. (Author), Irvin, S.C (Author), Li, N. (Author), Mao, Y. (Author), Partridge, M.A (Author), Sumner, G. (Author), Torri, A. (Author), Turner, K.C (Author), Weiss, R. (Author), Yan, H. (Author), Zhong, X. (Author)
Format: Article
Language:English
Published: Future Medicine Ltd. 2021
Subjects:
adult
Antibodies, Monoclonal
Article
bioanalytical
Bland-Altman
casirivimab
Chromatography, Liquid
comparative study
coronavirus disease 2019
COVID-19
drug blood level
drug concentration assay
drug screening
electrochemical analysis
Electrochemical Techniques
electrochemiluminescence immunoassay
emergency health service
high throughput analysis
human
Humans
imdevimab
immunoassay
immunology
liquid chromatography
liquid chromatography-mass spectrometry
luminescence
Luminescence
mass spectrometry
Mass Spectrometry
molecularly targeted therapy
monoclonal antibody
monoclonal antibody therapeutic
multiple reaction monitoring
pandemic
pharmacokinetic parameters
phase 1 clinical trial
phase 2 clinical trial
phase 3 clinical trial
procedures
public health service
SARS-CoV-2
therapy
virology
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