prikaz prve stranice dokumenta Validacija Endosafe PTS sustava i razvoj postupka testiranja kulture keratinocita i limbalnih stanica na endotoksine
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master's thesis
Validacija Endosafe PTS sustava i razvoj postupka testiranja kulture keratinocita i limbalnih stanica na endotoksine
Zagreb: University of Zagreb, Faculty of Food Technology and Biotechnology, 2017. urn:nbn:hr:159:094300
Blažević, Valentina
University of Zagreb
Faculty of Food Technology and Biotechnology
Department of Biochemical Engineering
Laboratory for Cell Technology, Application and Biotransformations

Institutional repository: Repository of the Faculty of Food Technology and Biotechnology

Cite this document

Blažević, V. (2017). Validacija Endosafe PTS sustava i razvoj postupka testiranja kulture keratinocita i limbalnih stanica na endotoksine (Master's thesis). Zagreb: University of Zagreb, Faculty of Food Technology and Biotechnology. Retrieved from https://urn.nsk.hr/urn:nbn:hr:159:094300

Blažević, Valentina. "Validacija Endosafe PTS sustava i razvoj postupka testiranja kulture keratinocita i limbalnih stanica na endotoksine." Master's thesis, University of Zagreb, Faculty of Food Technology and Biotechnology, 2017. https://urn.nsk.hr/urn:nbn:hr:159:094300

Blažević, Valentina. "Validacija Endosafe PTS sustava i razvoj postupka testiranja kulture keratinocita i limbalnih stanica na endotoksine." Master's thesis, University of Zagreb, Faculty of Food Technology and Biotechnology, 2017. https://urn.nsk.hr/urn:nbn:hr:159:094300

Blažević, V. (2017). 'Validacija Endosafe PTS sustava i razvoj postupka testiranja kulture keratinocita i limbalnih stanica na endotoksine', Master's thesis, University of Zagreb, Faculty of Food Technology and Biotechnology, accessed 05 August 2024, https://urn.nsk.hr/urn:nbn:hr:159:094300

Blažević V. Validacija Endosafe PTS sustava i razvoj postupka testiranja kulture keratinocita i limbalnih stanica na endotoksine [Master's thesis]. Zagreb: University of Zagreb, Faculty of Food Technology and Biotechnology; 2017 [cited 2024 August 05] Available at: https://urn.nsk.hr/urn:nbn:hr:159:094300

V. Blažević, "Validacija Endosafe PTS sustava i razvoj postupka testiranja kulture keratinocita i limbalnih stanica na endotoksine", Master's thesis, University of Zagreb, Faculty of Food Technology and Biotechnology, Zagreb, 2017. Available at: https://urn.nsk.hr/urn:nbn:hr:159:094300

Metadata
TitleValidacija Endosafe PTS sustava i razvoj postupka testiranja kulture keratinocita i limbalnih stanica na endotoksine
Title (english)Validation of Endosafe PTS system and practical approach for endotoxin testing of keratinocytes and limbal stem cells
AuthorValentina Blažević
MentorVišnja Gaurina Srček (mentor)
GranterUniversity of Zagreb
Faculty of Food Technology and Biotechnology
(Department of Biochemical Engineering)
(Laboratory for Cell Technology, Application and Biotransformations)
Zagreb
Defense date and country2017-07-21, Croatia
Scientific / art field,
discipline and subdiscipline		BIOTECHNICAL SCIENCES
Biotechnology
Abstract
Stanična terapija keratinocitima i limbalnim stanicama pripada ATMP proizvodima koji se koriste za kliničku primjenu, stoga je potrebno osigurati visoku razinu sigurnosti i kvalitete. Endotoksini su komponente stanične stijenke gram-negativnih bakterija, kod pacijenta mogu izazvati septički šok i smrt. Proizvodi stanične terapije imaju potencijal za uvođenje endotoksina izravno u krv. Svrha ovog rada bila je razvoj postupka testiranja stanične kulture keratinocita i limbalnih stanica na prisutnost endotoksina putem komercijalnog Endosafe PTS sustava koji se temelji na LAL metodi. Prilikom provođenja testiranja na endotoksine razvijen je izračun putem kojeg je moguće definirati prihvatljive vrijednosti koncentracije endotoksina u proizvodu u skladu s smjernicama FDA, Europske farmakopeje 2.6.14. i ISO standardima. Endosafe PTS sustav uspješno je validiran za testiranje otpadnog medija kulture stanica na prisutnost endotoksina unutar kratkog vremenskog roka. Prilikom testiranja javile su se interferencije uzorka s LAL reagensom koje su uspješno prevladane razrjeđivanjem uzorka do MVD vrijednosti koja je određena za svakog pojedinog pacijenta. Nadalje, endotoksini snažno adheriraju na staklenu površinu, te uklanjanje endotoksina predstavlja kritičnu točku prilikom pohrane GM medija. GM medij testiran je na endotoksine tijekom 24 h i 11 dana, u staklenim bocama nije zabilježeno povećanje koncentracije endotoksina.
Abstract (english)
Limbal stem cells and keratinocytes for clinical use are considered as an Advanced Therapy Medicinal Product (ATMP).It is necessary to ensure a high level of safety and quality of the ATMPs. Endotoxins are part of the outer membrane of the cell wall of Gram-negative. In a blood stream, presence of endotoxins can lead to spetic shock and death. Somatic cell therapy products have the potential to introduce endotoxin directly into the blood. The aim of this thesis was to validated a commercial Endosafe PTS system for the determination of endotoxins in complience with EU Pharmacopoeia 2.6.14, FDA guidelines and ISO standards. The Endosafe PTS system has been successfully validated for the testing of cell culture media in a short period of time. During the testing for endotoxins, interference of some sample was successfully overcome by diluting the sample to the MVD value determined for each individual patient. Removal of endotoxin is a critical point at storage GM media because endotoxins strongly adhere to the surface of glass. The GM medium was tested on endotoxins for 24 h and 11 days and there has been no increase in endotoxin concentration in glass containers.
Keywords
Keywords (english)
Languagecroatian
URN:NBNurn:nbn:hr:159:094300
Study programmeTitle: Molecular Biotechnology
Study programme type: university
Study level: graduate
Academic / professional title: magistar/magistra inženjer/inženjerka molekularne biotehnologije (magistar/magistra inženjer/inženjerka molekularne biotehnologije)
Type of resourceText
File originBorn digital
Access conditionsClosed access
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Created on2017-11-07 13:22:52