An overview of quantitative PCR assays for biologicals: quality and safety evaluation.
Applications of real time quantitative PCR (Q-PCR) to the evaluation of biologicals quality and safety are discussed in the following areas: (i) endogenous retrovirus load quantification in production cell cultures, (ii) viral clearance studies, (iii) lot release testing, (iv) detection of specific viral contaminants for raw material screen and in-process control, (v) mycoplasma and bioburden detection, (vi) host cell DNA quantification, and (vii) genetic stability characterization of production cell lines.
Xu
Y
Y
Genentech, Inc., S. San Francisco, CA 94080, USA. xu.yuan@gene.com
Brorson
K
K
D000818:Animals; D001688:Biological Products / Q000592:standards*; D018929:Cell Culture Techniques / Q000379:methods; D002460:Cell Line; D004340:Drug Contamination; D020077:Endogenous Retroviruses / Q000737:chemistry; D005069:Evaluation Studies as Topic; D005374:Filtration / Q000295:instrumentation / Q000379:methods; D042822:Genomic Instability; D033161:Government Regulation; D006801:Humans; D009174:Mycoplasma; D016133:Polymerase Chain Reaction / Q000379:methods / Q000592:standards; D011786:Quality Control; D012449:Safety; D013242:Sterilization / Q000295:instrumentation / Q000379:methods
D001688:Biological Products