Determination of antibiotic impurities in good manufacturing practices-grade cell therapy medicinal products
Yükleniyor...
Dosyalar
Tarih
2020
Yazarlar
Dergi Başlığı
Dergi ISSN
Cilt Başlığı
Yayıncı
Taylor & Francis Inc
Erişim Hakkı
info:eu-repo/semantics/closedAccess
Özet
Backrounds: 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.
Açıklama
Anahtar Kelimeler
Cellular Therapy, Good Manufacturing Practices, Lc-Ms, Ms, Penicillin, Streptomycin
Kaynak
Preparative Biochemistry & Biotechnology
WoS Q Değeri
Q4
Scopus Q Değeri
Q3
Cilt
50
Sayı
2
Künye
Oztel, 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.
