Development of a quantitative PCR assay for residual mouse DNA and comparison of four sample purification methods for DNA isolation

Reliable and sensitive assays are required to determine whether a pharmaceutical product meets current regulatory guidelines for residual host cell DNA. In this study, the sensitivity of the qPCR assay was significantly improved by targeting the repetitive elements of mouse genome. This improved met...

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Veröffentlicht in:	Journal of pharmaceutical and biomedical analysis 2011-04, Vol.55 (1), p.71-77
Hauptverfasser:	Cai, Hui, Gu, Xuelin, Scanlan, Mary S., Lively, Chris R.
Format:	Artikel
Sprache:	eng
Schlagworte:	Algorithms Analysis Analytical, structural and metabolic biochemistry Animals Antibodies, Monoclonal Biological and medical sciences compliance DNA DNA - analysis DNA - isolation & purification DNA isolation DNA quantitation Drug Contamination - prevention & control Fundamental and applied biological sciences. Psychology General pharmacology genome Genomes genomics Glycogen guidelines Host cell DNA Immunoglobulin G Immunoglobulin G - therapeutic use isolation techniques Limit of Detection Medical sciences Mice Microchemistry - methods Monoclonal antibodies pharmaceutical industry Pharmaceuticals Pharmacology. Drug treatments Polymerase Chain Reaction protein purification purification methods Quality control Quantitation quantitative analysis Quantitative PCR quantitative polymerase chain reaction Real-time PCR Recombinant Proteins - therapeutic use Repeated DNA sequences Repetitive Sequences, Nucleic Acid - genetics Reproducibility of Results Technology, Pharmaceutical - standards
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