Simultaneous quantification of spike and nucleocapsid protein in inactivated COVID-19 vaccine bulk by liquid chromatography-tandem mass spectrometry.
J Chromatogr B Analyt Technol Biomed Life Sci
; 1181: 122884, 2021 Sep 01.
Article
in English
| MEDLINE | ID: covidwho-1364212
ABSTRACT
Severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) vaccines are the most promising approach to control the COVID-19 pandemic. There are eminent needs to develop robust analytical methods to ensure quality control, as well as to evaluate the long-term efficacy and safety of vaccine. Although in vivo animal tests, such as serum-based ELISA, have been commonly used for quality control of vaccines, these methods have poor precision, are labor intensive, and require the availability of expensive, specific antibodies. Thus, there is growing interest to develop robust bioanalytical assays as alternatives for qualitative and quantitative evaluation of complex vaccine antigens. In this study, a liquid chromatography tandem mass spectrometry method was developed using optimized unique peptides for simultaneous determination of spike (S) and nucleocapsid (N) protein. Method sensitivity, linearity, repeatability, selectivity, and recovery were evaluated. The amount of S and N proteins in 9 batches of inactivated COVID-19 vaccines were quantified, and their compositions relative to total protein content were consistent. We believe this method can be applied for quality evaluation of other S and/or N protein based COVID-19 vaccine, and could be extended to other viral vector, and protein subunit-based vaccines.
Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Chromatography, Liquid
/
Tandem Mass Spectrometry
/
Spike Glycoprotein, Coronavirus
/
Coronavirus Nucleocapsid Proteins
/
COVID-19 Vaccines
/
SARS-CoV-2
Type of study:
Experimental Studies
/
Qualitative research
Topics:
Vaccines
Limits:
Humans
Language:
English
Journal:
J Chromatogr B Analyt Technol Biomed Life Sci
Journal subject:
Biomedical Engineering
Year:
2021
Document Type:
Article
Affiliation country:
J.jchromb.2021.122884
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