Razvoj i validacija spektroskopijske metode bliskoga infracrvenoga zračenja za određivanje udjela vode u cjepivu protiv meningokoka serogrupa A i C

Fabijanić, Ines

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doctoral thesis

Razvoj i validacija spektroskopijske metode bliskoga infracrvenoga zračenja za određivanje udjela vode u cjepivu protiv meningokoka serogrupa A i C

Zagreb: University of Zagreb, Faculty of Food Technology and Biotechnology, 2021. urn:nbn:hr:159:333906

Fabijanić, Ines

University of Zagreb
Faculty of Food Technology and Biotechnology
Department of Biochemical Engineering
Laboratory for Biochemical Engineering, Industrial Microbiology and Malting and Brewing Technology

Cite this document

APA 6th Edition

Fabijanić, I. (2021). Razvoj i validacija spektroskopijske metode bliskoga infracrvenoga zračenja za određivanje udjela vode u cjepivu protiv meningokoka serogrupa A i C (Doctoral thesis). Retrieved from https://urn.nsk.hr/urn:nbn:hr:159:333906

MLA 8th Edition

Fabijanić, Ines. "Razvoj i validacija spektroskopijske metode bliskoga infracrvenoga zračenja za određivanje udjela vode u cjepivu protiv meningokoka serogrupa A i C." Doctoral thesis, University of Zagreb, Faculty of Food Technology and Biotechnology, 2021. https://urn.nsk.hr/urn:nbn:hr:159:333906

Chicago 17th Edition

Harvard

Fabijanić, I. (2021). 'Razvoj i validacija spektroskopijske metode bliskoga infracrvenoga zračenja za određivanje udjela vode u cjepivu protiv meningokoka serogrupa A i C', Doctoral thesis, University of Zagreb, Faculty of Food Technology and Biotechnology, accessed 25 March 2023, https://urn.nsk.hr/urn:nbn:hr:159:333906

Vancouver

Fabijanić I. Razvoj i validacija spektroskopijske metode bliskoga infracrvenoga zračenja za određivanje udjela vode u cjepivu protiv meningokoka serogrupa A i C [Doctoral thesis]. Zagreb: University of Zagreb, Faculty of Food Technology and Biotechnology; 2021 [cited 2023 March 25] Available at: https://urn.nsk.hr/urn:nbn:hr:159:333906

IEEE

I. Fabijanić, "Razvoj i validacija spektroskopijske metode bliskoga infracrvenoga zračenja za određivanje udjela vode u cjepivu protiv meningokoka serogrupa A i C", Doctoral thesis, University of Zagreb, Faculty of Food Technology and Biotechnology, Zagreb, 2021. Available at: https://urn.nsk.hr/urn:nbn:hr:159:333906

Cite this item: https://urn.nsk.hr/urn:nbn:hr:159:333906

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Title	Razvoj i validacija spektroskopijske metode bliskoga infracrvenoga zračenja za određivanje udjela vode u cjepivu protiv meningokoka serogrupa A i C
Title (english)	Development and validation of a near-infrared spectroscopic method for water content determination in meningococcal vaccine serogroups A and C
Author	Ines Fabijanić MBZ: 257081
Mentor	Anita Slavica (mentor)
Committee member	Jagoda Šušković (član povjerenstva)
Granter	University of Zagreb Faculty of Food Technology and Biotechnology (Department of Biochemical Engineering) (Laboratory for Biochemical Engineering, Industrial Microbiology and Malting and Brewing Technology) Zagreb
Defense date and country	2021-07-07, Croatia
Scientific / art field, discipline and subdiscipline	BIOTECHNICAL SCIENCES Biotechnology
Universal decimal classification (UDC)	615 - Pharmacology. Therapeutics. Toxicology
Abstract	Cilj ovog rada je bio razviti i validirati nove spektroskopijske metode bliskoga infracrvenoga zračenja (NIR) za određivanje udjela vode u liofiliziranom cjepivu protiv meningokoka serogrupa A i C i pročišćenim meningokoknim polisaharidima serogrupe (PMPS) A i C prema sustavnom pristupu procesne analitičke tehnologije (PAT). Novi eksperimetalni dizajn temeljen na metodi standardnog dodavanja u liofilizirana cjepiva omogućio je procjenu točnosti predikcije NIR modela, obuhvativši mjerne nesigurnosti NIR modela i sustavnu pogrešku referentne Karl-Fischer metode. Utvrđeno je da na rezultate određivanja ostatne vode u liofiliziranom cjepivu standardnom Karl-Fischer metodom utječe atmosferska vlaga te je osmišljena Karl-Fischer metoda koja udovoljava kriterijima za referentnu metodu. Profil točnosti potvrdio je da NIR model točno određuje udjel vode u liofiliziranom cjepivu u rasponu od 1,0 - 6,7 %. Izvedbene karakteristike optimalnih NIR modela za određivanje udjela vode u djelatnim tvarima, PMPS A i PMPS C procijenjene su na temelju kemometrijskih parametara. Rezultati ovog rada upućuju na potencijal primjene novih NIR metoda u praćenju kritičnog parametra kvalitete - udjela vode u stvarnom vremenu u svim fazama proizvodnje liofiliziranog cjepiva protiv meningokoka serogrupa A i C prema sustavnom PAT pristupu skraćujući vrijeme za puštanje serije lijeka u promet.
Abstract (english)	The aim of the present study was to develop and validate near-infrared (NIR) spectroscopic methods for water content determination in freeze-dried meningococcal vaccine serogroups A and C and purified meningococcal polysaccharides serogroups (PMPS) A and C in accordance with Process Analytical Technology (PAT). A novel approach based on the standard addition method in freeze-dried vaccines is proposed to clearly demonstrate the NIR model’s ability to give accurate predictions, by evaluating not only uncertainties associated with the NIR calibration model, but also systematic error arising from the reference Karl-Fischer method. However, results for water content in freeze-dried vaccine obtained by standard Karl-Fischer method were influenced by atmospheric moisture. Consequently, the suitability of the newly proposed Karl-Fischer for a reference method was confirmed. The accuracy profile showed that the NIR model successfully determined water content over the 1.0–6.7 % range. In addition, the best NIR models for drug substances, PMPS A and PMPS C were evaluated based on chemometric parameters. The present study confirmed that NIR methods could be used in the PAT concept for monitoring of critical quality parameter - water content in all production phases of freeze-dried meningococcal vaccine serogroups A and C in a timely manner therefore reducing a batch release time.
Keywords
Keywords (english)
Language	croatian
URN:NBN	urn:nbn:hr:159:333906
Promotion	2021
Study programme	Title: Postgraduate PhD Study in Nutrition Study programme type: university Study level: postgraduate Academic / professional title: doktor/doktorica znanosti, područje biotehničkih znanosti, polje nutricionizam (doktor/doktorica znanosti, područje biotehničkih znanosti, polje nutricionizam)
Type of resource	Text
Extent	171 str. : 30 cm
File origin	Born digital
Access conditions	Open access
Terms of use
Repository	Repository of the Faculty of Food Technology and Biotechnology
Created on	2021-11-23 13:04:22