Determination of antibiotic impurities in good manufacturing practices-grade cell therapy medicinal products

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dc.authoridErdal Karaöz / 0000-0002-9992-833Xen_US
dc.authoridOlga Nehir Öztel / 0000-0002-8019-6810
dc.authorscopusidErdal Karaöz / 7003448087
dc.authorscopusidOlga Nehir Öztel / 37111307900
dc.authorwosidErdal Karaöz / IXE-6677-2023
dc.authorwosidOlga Nehir Öztel / AAX-2767-2020
dc.contributor.authorÖztel, Olga Nehiren_US
dc.contributor.authorKorkmaz, Sevalen_US
dc.contributor.authorKaraöz, Erdalen_US
dc.date.accessioned2020-08-30T20:06:30Z
dc.date.available2020-08-30T20:06:30Z
dc.date.issued2020
dc.departmentİstinye Üniversitesi, Sağlık Hizmetleri Meslek Yüksekokulu, Tıbbi Laboratuvar Teknikleri Bölümüen_US
dc.description.abstractBackrounds: According to the regulations of the health autorities, cell-based therapy products must be manufactured in good manufacturing production (GMP) facilities, fulfilling the required GMP standards. Products developed under the high quality control (QC) necessarity need to be approved for some QC tests. One of the main residual test is antibiotic test and this test should be validated. The aim of this study is to validate and determine the methods of detection of the antibiotic residue in the final product. Methods: Liquid Chromatography Tandem-Mass Spectrometry (LC-MS/MS) methods were used for the main steps of the production procedure, as well as the final products. Pharmaceutical Grade penicillin G and streptomycin sulfate were used as positive controls. Results: The results suggest that penicillin is broken down during cell culture and streptomycin is eliminated at the first washing step of the final product manufacture. It is shown in this study that LC-MS/MS method is one of the convenient method to test residual anibiotics and can be used to detect the antibiotic residues in cellular therapy products. Discussion: Since the antibiotic residues are eliminated in the final product and also it could be suggested that the methodology we followed is sufficiently safe and final product is pure.en_US
dc.identifier.citationOztel, O. N., Korkmaz, S., & Karaoz, E. (2020). Determination of antibiotic impurities in good manufacturing practices-grade cell therapy medicinal products. Preparative Biochemistry & Biotechnology, 50(2), 156-163.en_US
dc.identifier.doi10.1080/10826068.2019.1676780en_US
dc.identifier.endpage163en_US
dc.identifier.issn1082-6068en_US
dc.identifier.issn1532-2297en_US
dc.identifier.issue2en_US
dc.identifier.pmid31631751en_US
dc.identifier.scopus2-s2.0-85074412228en_US
dc.identifier.scopusqualityQ3en_US
dc.identifier.startpage156en_US
dc.identifier.urihttps://doi.org/10.1080/10826068.2019.1676780
dc.identifier.urihttps://hdl.handle.net/20.500.12713/537
dc.identifier.volume50en_US
dc.identifier.wosWOS:000491851500001en_US
dc.identifier.wosqualityQ4en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.institutionauthorÖztel, Olga Nehiren_US
dc.institutionauthorKaraöz, Erdalen_US
dc.language.isoenen_US
dc.publisherTaylor & Francis Incen_US
dc.relation.ispartofPreparative Biochemistry & Biotechnologyen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/closedAccessen_US
dc.subjectCellular Therapyen_US
dc.subjectGood Manufacturing Practicesen_US
dc.subjectLc-Msen_US
dc.subjectMsen_US
dc.subjectPenicillinen_US
dc.subjectStreptomycinen_US
dc.titleDetermination of antibiotic impurities in good manufacturing practices-grade cell therapy medicinal productsen_US
dc.typeArticleen_US

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