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Title: The quantitation of therapeutic olingonucleotides and their impurities analysed using hyphenated liquid chromatography and mass spectrometry
Author: Powley, Stephanie Louise
ISNI:       0000 0004 7234 2851
Awarding Body: University of Southampton
Current Institution: University of Southampton
Date of Award: 2018
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As demand for therapeutic oligonucleotide drugs to treat a wider range of conditions increases, there is a requirement for a robust method for the quantitation of the impurities within a drug product. The development of a method that can be employed across all laboratories, regardless of the Liquid chromatography – Mass spectrometry instrumentation used, is highly desirable to ensure consistency of testing and to confirm inter-batch variation. Factors influencing the reliability of quantitation have been investigated, including mobile phase additives, mass analyser type and in-source collision-induced dissociation voltage. Strategies for quantitating the data collected have also been considered and compared. The effect of the oligonucleotide sequence on the level of in-source fragmentation has been observed and discussed. Recommendations are made for the most appropriate mobile phase reagents, mass analyser type and method of quantitation to be used to allow the development of an analytical method for use across laboratories to accurately and precisely quantitate therapeutic oligonucleotides and their impurities.
Supervisor: Langley, Graham Sponsor: Not available
Qualification Name: Thesis (Ph.D.) Qualification Level: Doctoral
EThOS ID:  DOI: Not available