title: Size analysis of residual host cell DNA in cell culture-produced vaccines by capillary gel electrophoresis.
abstract: Residual host cell DNA poses potential safety concerns for cell culture-derived vaccines or other biological products. In addition to the quantity of residual DNA, the size distribution is an important measure for determination of its associated risk factor. We have developed a new method for residual DNA size analysis, based on capillary gel electrophoresis (CGE) technology with sensitive laser induced fluorescence detection (LIF). The performance of this method was optimized through empirical selection of appropriate testing conditions and optimized conditions are presented. Examples are given to demonstrate the successful employment of this method for residual DNA size analysis of cell culture-produced vaccine samples.
authors: MedImmune, 319 North Bernardo Avenue, Mountain View, CA 94043, USA.
authors: Xuan
authors: X
authors: Shen
authors: Xiaomu
authors: X
authors: Chen
authors: David E
authors: DE
authors: Tabor
authors: Yi
authors: Y
authors: Liu
authors: Methal
authors: M
authors: Albarghouthi
authors: Yi-Fan
authors: YF
authors: Zhang
authors: Mark S
authors: MS
authors: Galinski
mesh_terms: D000818:Animals; D002460:Cell Line; D002522:Chlorocebus aethiops; D004247:DNA / Q000032:analysis* / Q000235:genetics; D019075:Electrophoresis, Capillary / Q000379:methods*; D005453:Fluorescence; D007252:Influenza Vaccines / Q000096:biosynthesis / Q000235:genetics; D016133:Polymerase Chain Reaction; D015203:Reproducibility of Results; D022261:Respiratory Syncytial Virus Vaccines / Q000096:biosynthesis / Q000235:genetics; D014709:Vero Cells; D014765:Viral Vaccines / Q000096:biosynthesis* / Q000235:genetics
chemical_list: D007252:Influenza Vaccines; D022261:Respiratory Syncytial Virus Vaccines; D014765:Viral Vaccines; D004247:DNA