REGEN-COV® antibody cocktail bioanalytical strategy: comparison of LC-MRM-MS and immunoassay methods for drug quantification.
Bioanalysis
; 13(24): 1827-1836, 2021 Dec.
Article
in English
| MEDLINE | ID: covidwho-1506143
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
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Mass Spectrometry
/
Chromatography, Liquid
/
SARS-CoV-2
/
COVID-19
/
Antibodies, Monoclonal
Type of study:
Prognostic study
Limits:
Humans
Language:
English
Journal:
Bioanalysis
Year:
2021
Document Type:
Article
Affiliation country:
Bio-2021-0190
Similar
MEDLINE
...
LILACS
LIS