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REGEN-COVĀ® antibody cocktail bioanalytical strategy: comparison of LC-MRM-MS and immunoassay methods for drug quantification
- Source :
- Bioanalysis
- Publication Year :
- 2021
- Publisher :
- Future Science Ltd, 2021.
-
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.
- Subjects :
- Bioanalytical Challenge
Drug
Bioanalysis
Luminescence
Coronavirus disease 2019 (COVID-19)
media_common.quotation_subject
Clinical Biochemistry
Bland-Altman
Mass Spectrometry
Analytical Chemistry
Pharmacokinetics
Humans
Medicine
Electrochemiluminescence
monoclonal antibody therapeutic
General Pharmacology, Toxicology and Pharmaceutics
media_common
Chromatography
medicine.diagnostic_test
biology
SARS-CoV-2
business.industry
Antibodies, Monoclonal
COVID-19
Electrochemical Techniques
General Medicine
Medical Laboratory Technology
Immunoassay
Lc mrm ms
biology.protein
drug concentration assay
Antibody
business
bioanalytical
Chromatography, Liquid
Subjects
Details
- ISSN :
- 17576199 and 17576180
- Volume :
- 13
- Database :
- OpenAIRE
- Journal :
- Bioanalysis
- Accession number :
- edsair.doi.dedup.....5a6b10c4186afedf521aa00986148e4d