TY  - JOUR
TI  - Utility investigation of automated techniques in hematopoietic progenitor cell count and viability assessment in the Good Manufacturing Practice (GMP) setting
AB  - Aim: To compare our parameters as regards: i) cell count via two different automated cell count techniques, and ii) viability via automated trypan blue exclusion and 7-aminoactinomycin D (7-AAD) staining.Method: We used the trypan blue exclusion technique and an automated cell counter and for viability testing, and the trypan blue exclusion technique and the 7-AAD evaluation by flow cytometry. The trypan blue exclusion and the radio frequency techniques were used for automated cell counting. Flow cytometric analysis was performed by evaluating the yielded cellular products for 7-AAD uptake during the cell count of CD34+ cells.Results: The mean values for cell count were estimated as 3.44±1.22x106/ml (range, 2.48-5.71x106/ml) and 4.14±1.94x106/ml (range, 1.77-7.43x106/ml) for the trypan blue exclusion and radio frequency techniques, respectively. Additionally, the mean values for viability analyses via the automated trypan blue exclusion and 7-AAD were 93.38±6.09% (range, 79.00-98.00%) and 99.49±0.60% (range, 98.40-100.00%), respectively.Conclusions: Our study has responded to two fundamental questions: whether the results of both of the automated techniques for cell count correspond with each other, and whether the results of the automated viability assessment conform those of the 7-AAD technique during the manufacturing processes of cellular therapy products intended for clinical use. Even though we have the opportunity to use the hemocytometer in our laboratory setting, the automated trypan blue exclusion technique gives cell count results in concordance within the range of the expectations of our Quality Management System (QMS).
AU  - Kilic, Pelin
AU  - Cevheroğlu, Orkun
AU  - Dalva, Klara
AU  - Parmaksiz, Mahmut
AU  - ÇUBUKÇUOĞLU, Günseli Deniz
AU  - Yilmazer, Açelya
AU  - Seker, Sukran
AU  - LALEGÜL ÜLKER, OZGE
AU  - ÖZTÜRK, AYDIN
AU  - İPEK, ŞENAY
AU  - OZKAL BAYDIN, PINAR
AU  - Elcin, Ayse Eser
AU  - Gürman, Günhan
AU  - bitirim, ceylan verda
AU  - Bay, Meltem
AU  - Çoşkun, Öznur
DO  - 10.30714/j-ebr.2020463606
PY  - 2020
JO  - Experimental Biomedical Research
VL  - 3
IS  - 4
SN  - 2618-6454
SP  - 231
EP  - 238
DB  - TRDizin
UR  - http://search/yayin/detay/411779
ER  -