Development and qualification of a high sensitivity, high throughput Q-PCR assay for quantitation of residual host cell DNA in purification process intermediate and drug substance samples

Journal of Pharmaceutical and Biomedical Analysis

Volumn 100, Issue , 2014, Pages 145-149

  Zhang, Wei ^a   Wu, Meng ^a   Menesale, Emily ^a   Lu, Tongjun ^a   Magliola, Aeona ^a   Bergelson, Svetlana ^a  

^a BIOGEN   (United States)

Author keywords

Alu repeats; Automation; DNA quantitation; Q PCR; Residual host cell DNA

Indexed keywords

CELL DNA; GLYCERALDEHYDE 3 PHOSPHATE DEHYDROGENASE; MAGNETIC NANOPARTICLE; PRIMER DNA; PROTEIN; DRUG; MONOCLONAL ANTIBODY; SODIUM IODIDE; DNA; RECOMBINANT PROTEIN;

ALU REPEAT; ARTICLE; AUTOMATION; CHINESE HAMSTER; CONTROLLED STUDY; DNA DETERMINATION; DNA EXTRACTION; DNA PROBE; DNA PURIFICATION; DNA SEQUENCE; DNA STRUCTURE; DRUG PURIFICATION; GENOME; HOST CELL; LIMIT OF QUANTITATION; NONHUMAN; POLYMERASE CHAIN REACTION; PRIORITY JOURNAL; PROTEIN PURIFICATION; QUANTITATIVE ANALYSIS; SENSITIVITY AND SPECIFICITY; ACCURACY; ALU SEQUENCE; DEVICES; GAPDH GENE; GENE; GENE DOSAGE; HUMAN; HUMAN CELL; MURINAE; QUALITATIVE ANALYSIS; REPRODUCIBILITY; SENSITIVITY ANALYSIS; SPECIES DIFFERENCE; ANIMAL; BIOSYNTHESIS; CHO CELL LINE; COMPARATIVE STUDY; CRICETULUS; DRUG CONTAMINATION; EVALUATION STUDY; GENETIC TRANSFECTION; GENETICS; HEK293 CELL LINE; HIGH THROUGHPUT SEQUENCING; ISOLATION AND PURIFICATION; LABORATORY AUTOMATION; LIMIT OF DETECTION; MOUSE; PROCEDURES;

ALU ELEMENTS; ANIMALS; AUTOMATION, LABORATORY; CHO CELLS; CRICETULUS; DNA; DNA PRIMERS; DRUG CONTAMINATION; GLYCERALDEHYDE-3-PHOSPHATE DEHYDROGENASES; HEK293 CELLS; HIGH-THROUGHPUT NUCLEOTIDE SEQUENCING; HUMANS; LIMIT OF DETECTION; MICE; POLYMERASE CHAIN REACTION; RECOMBINANT PROTEINS; REPRODUCIBILITY OF RESULTS; TRANSFECTION;

EID: 84906495821     PISSN: 07317085     EISSN: 1873264X     Source Type: Journal    
DOI: 10.1016/j.jpba.2014.07.037     Document Type: Article

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