Isolation and characterization of the environmental bacterial and fungi contamination in a pharmaceutical unit of mesenchymal stem cell for clinical use.
Design and implementation of an environmental monitoring program is vital to assure the maintenance of acceptable quality conditions in a pharmaceutical manufacturing unit of human mesenchymal stem cells. Since sterility testing methods require 14 days and these cells are only viable for several hours, they are currently administered without the result of this test. Consequently environmental monitoring is a key element in stem cell banks for assuring low levels of potential introduction of contaminants into the cell products. The aim of this study was to qualitatively and quantitatively analyze the environmental microbiological quality in a pharmaceutical manufacturing unit of human mesenchymal stem cells production for use in advanced therapies. Two hundred and sixty one points were tested monthly during one year, 156 from air and 105 from surfaces. Among the 6264 samples tested, 231 showed contamination, 76.6% for bacteria and 23.4% for fungi. Microbial genuses isolated were Staphylococcus (89.7%), Microccocus (4.5%), Kocuria (3.2%) and Bacillus (2.6%). In the identification of fungi, three genuses were detected: Aspergillus (56%), Penicillium (26%) and Cladosporium (18%). The origin of the contamination was found to be due to personnel manipulation and air microbiota. For all sampling methods, alert limits were set and corrective measures suggested.
Quality Control Department, Andalusian Molecular Biology and Regenerative Medicine Centre (CABIMER), Americio Vespucio Ave., 41092 Seville, Spain.
Patricia Gálvez
PG
Martín
María Bermejo
MB
González
Adolfina Ruiz
AR
Martínez
Visitación Gallardo
VG
Lara
Beatriz Clares
BC
Naveros
D000391:Air Microbiology; D001419:Bacteria / Q000302:isolation & purification; D002469:Cell Separation / Q000379:methods; D002478:Cells, Cultured; D017321:Clinical Trials, Phase I as Topic; D017322:Clinical Trials, Phase II as Topic; D004340:Drug Contamination; D004777:Environment; D004784:Environmental Monitoring / Q000379:methods*; D005658:Fungi / Q000302:isolation & purification; D006801:Humans; D045164:Mesenchymal Stem Cell Transplantation / Q000592:standards; D059630:Mesenchymal Stem Cells / Q000166:cytology* / Q000382:microbiology*; D008828:Microbiological Techniques; D004364:Pharmaceutical Preparations / Q000032:analysis; D013048:Specimen Handling / Q000379:methods* / Q000592:standards
D004364:Pharmaceutical Preparations