The development of physico-chemical quality control methods for Haemophilus influenzae type b vaccine production

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dc.contributor.advisorRavenscroft, Neil
dc.contributor.authorBehr,Heinrich Richarden_ZA
dc.date.accessioned2014-08-15T14:21:00Z
dc.date.available2014-08-15T14:21:00Z
dc.date.issued2013
dc.description.abstractThe development of a low cost Haemophilus influenzaetype b (Hib) manufacturing platform at The Biovac Institute (TBI) required analytical method development in parallel with the production process development. Technology transfer enabled TBI to develop Hib vaccine production which could lead to the development of vaccine manufacturing capacity in subSaharan Africa. Initial studies were conducted in the Research and Development (R&D) department from where the process was transferred to the Good Manufacturing Process (GMP) environments of the Production and Quality Control departments respectively. Scaling of the development process to a process commercially viable required the development of additional quality control test methods. The quality control of Hib is performed by characterisation of the manufactured batch using physico-chemical analysis. The data generated are compared against that of a successful clinical trial batch. Animal based models for the potency and safety tests of Hib are ineffective. Chromatographic methods of analysis are often used in the pharmaceutical and biotechnological industry. Gas chromatography with flame ionisation detection (GC-FID) is a conventional technique used for the analysis of volatile analytes. The analysis of process residuals ethanol and ethylene glycol were performed using headspace or direct injection GC-FID analysis. Ethylene glycol, a non-volatile solvent, was chemically dried after which it was derivatised with a trimethylsilylating reagent. In addition, a method was developed to determine polyribosylribitolphosphate. Samples were dried by means of lyophilisation and then subjected to methanolysis to yield methyl glycosides. A trimethylsilylating reagent was used to volatilise the analyte and analysis was performed using GC-FID with direct injection. The use of internal standards throughout the sample preparation processes minimised errors due to sample handling, processing or injector reproducibility. Analytical method validation parameters were applied to the developed methods.en_ZA
dc.identifier.apacitation (2013). <i>The development of physico-chemical quality control methods for Haemophilus influenzae type b vaccine production</i>. (Thesis). University of Cape Town ,Faculty of Science ,Department of Chemistry. Retrieved from http://hdl.handle.net/11427/6581en_ZA
dc.identifier.chicagocitation. <i>"The development of physico-chemical quality control methods for Haemophilus influenzae type b vaccine production."</i> Thesis., University of Cape Town ,Faculty of Science ,Department of Chemistry, 2013. http://hdl.handle.net/11427/6581en_ZA
dc.identifier.citation 2013. The development of physico-chemical quality control methods for Haemophilus influenzae type b vaccine production. Thesis. University of Cape Town ,Faculty of Science ,Department of Chemistry. http://hdl.handle.net/11427/6581en_ZA
dc.identifier.ris TY - Thesis / Dissertation AU - Behr,Heinrich Richard AB - The development of a low cost Haemophilus influenzaetype b (Hib) manufacturing platform at The Biovac Institute (TBI) required analytical method development in parallel with the production process development. Technology transfer enabled TBI to develop Hib vaccine production which could lead to the development of vaccine manufacturing capacity in subSaharan Africa. Initial studies were conducted in the Research and Development (R&D) department from where the process was transferred to the Good Manufacturing Process (GMP) environments of the Production and Quality Control departments respectively. Scaling of the development process to a process commercially viable required the development of additional quality control test methods. The quality control of Hib is performed by characterisation of the manufactured batch using physico-chemical analysis. The data generated are compared against that of a successful clinical trial batch. Animal based models for the potency and safety tests of Hib are ineffective. Chromatographic methods of analysis are often used in the pharmaceutical and biotechnological industry. Gas chromatography with flame ionisation detection (GC-FID) is a conventional technique used for the analysis of volatile analytes. The analysis of process residuals ethanol and ethylene glycol were performed using headspace or direct injection GC-FID analysis. Ethylene glycol, a non-volatile solvent, was chemically dried after which it was derivatised with a trimethylsilylating reagent. In addition, a method was developed to determine polyribosylribitolphosphate. Samples were dried by means of lyophilisation and then subjected to methanolysis to yield methyl glycosides. A trimethylsilylating reagent was used to volatilise the analyte and analysis was performed using GC-FID with direct injection. The use of internal standards throughout the sample preparation processes minimised errors due to sample handling, processing or injector reproducibility. Analytical method validation parameters were applied to the developed methods. DA - 2013 DB - OpenUCT DP - University of Cape Town LK - https://open.uct.ac.za PB - University of Cape Town PY - 2013 T1 - The development of physico-chemical quality control methods for Haemophilus influenzae type b vaccine production TI - The development of physico-chemical quality control methods for Haemophilus influenzae type b vaccine production UR - http://hdl.handle.net/11427/6581 ER - en_ZA
dc.identifier.urihttp://hdl.handle.net/11427/6581
dc.identifier.vancouvercitation. The development of physico-chemical quality control methods for Haemophilus influenzae type b vaccine production. [Thesis]. University of Cape Town ,Faculty of Science ,Department of Chemistry, 2013 [cited yyyy month dd]. Available from: http://hdl.handle.net/11427/6581en_ZA
dc.language.isoengen_ZA
dc.publisher.departmentDepartment of Chemistryen_ZA
dc.publisher.facultyFaculty of Scienceen_ZA
dc.publisher.institutionUniversity of Cape Town
dc.titleThe development of physico-chemical quality control methods for Haemophilus influenzae type b vaccine productionen_ZA
dc.typeMaster Thesis
dc.type.qualificationlevelMasters
dc.type.qualificationnameMScen_ZA
uct.type.filetypeText
uct.type.filetypeImage
uct.type.publicationResearchen_ZA
uct.type.resourceThesisen_ZA
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