Design of a Quantitative LC-MS Method for Residual Toxins Adenylate Cyclase Toxin (ACT), Dermonecrotic Toxin (DNT) and Tracheal Cytotoxin (TCT) in Bordetella pertussis Vaccines

Autor:	Wai Wan Vivian Tam, Benjamin Messham, Lisa Szymkowicz, D. Andrew James, Jeffery Gerard
Rok vydání:	2021
Předmět:	Bordetella pertussis Health Toxicology and Mutagenesis dermonecrotic toxin Peptidoglycan Toxicology medicine.disease_cause Pertussis toxin Article Microbiology 03 medical and health sciences Antigen Tandem Mass Spectrometry vaccine Tracheal cytotoxin medicine Virulence Factors Bordetella mass spectrometry 030304 developmental biology 0303 health sciences Transglutaminases pertussis toxin biology 030306 microbiology Toxin Chemistry Selected reaction monitoring quantitative LC-MS biology.organism_classification Glycopeptide adenylate cyclase toxin 3. Good health tracheal cytotoxin Adenylate Cyclase Toxin Bacterial Vaccines Medicine Chromatography Liquid
Zdroj:	Toxins Volume 13 Issue 11 Toxins, Vol 13, Iss 763, p 763 (2021)
ISSN:	2072-6651
DOI:	10.3390/toxins13110763
Popis:	The antigens for acellular pertussis vaccines are made up of protein components that are purified directly from Bordetella pertussis (B. pertussis) bacterial fermentation. As such, there are additional B. pertussis toxins that must be monitored as residuals during process optimization. This paper describes a liquid chromatography mass spectrometry (LC-MS) method for simultaneous analysis of residual protein toxins adenylate cyclase toxin (ACT) and dermonecrotic toxin (DNT), as well as a small molecule glycopeptide, tracheal cytotoxin (TCT) in a Pertussis toxin vaccine antigen. A targeted LC-MS technique called multiple reaction monitoring (MRM) is used for quantitation of ACT and TCT, which have established limits in drug product formulations. However, DNT is currently monitored in an animal test, which does not have an established quantitative threshold. New approaches for DNT testing are discussed, including a novel standard based on concatenated quantitation sequences for ACT and DNT. Collectively, the method represents a “3-in-1” analytical simplification for monitoring process-related residuals during development of B. pertussis vaccines.
Databáze:	OpenAIRE
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