Optimization and validation of DNA extraction and real-time PCR assay for the quantitative measurement of residual host cell DNA in biopharmaceutical products

Journal of Pharmaceutical and Biomedical Analysis

Volumn 88, Issue , 2014, Pages 92-95

  Hu, B ^a   Sellers, J ^a   Kupec, J ^a   Ngo, W ^b   Fenton, S ^a   Yang, T Y ^a   Grebanier, A ^a  

^a Pharmaceutical Development and Manufacturing Sciences   (United States)

^b MERCK RESEARCH LABORATORIES   (United States)

Author keywords

CHO (Chinese Hamster Ovary); Monoclonal antibody; Quantitative real time PCR; Residual DNA; Sodium iodide extraction kit

Indexed keywords

BUFFER; DETERGENT; DNA; GENOMIC DNA; MONOCLONAL ANTIBODY; NUCLEOTIDE; PROTEIN A; PROTEINASE K; SODIUM IODIDE;

ARTICLE; BIOREACTOR; DNA CONTAMINATION; DNA EXTRACTION; DNA PURIFICATION; GENE AMPLIFICATION; GENE SEQUENCE; HOST CELL; NONHUMAN; PRECIPITATION; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; REAL TIME POLYMERASE CHAIN REACTION;

CHO (CHINESE HAMSTER OVARY); MONOCLONAL ANTIBODY; QUANTITATIVE REAL TIME PCR; RESIDUAL DNA; SODIUM IODIDE EXTRACTION KIT;

ANIMALS; ANTIBODIES, MONOCLONAL; BIOPHARMACEUTICS; CHO CELLS; CRICETINAE; CRICETULUS; DNA; OLIGONUCLEOTIDE PROBES; REAL-TIME POLYMERASE CHAIN REACTION; REPRODUCIBILITY OF RESULTS; SODIUM IODIDE; TIME FACTORS;

EID: 84884195168     PISSN: 07317085     EISSN: 1873264X     Source Type: Journal    
DOI: 10.1016/j.jpba.2013.08.027     Document Type: Article

References (6)

1. World Health Organization (WHO) WHO Expert Committee on Biological Standardization: Highlights of the 46th meeting, October 1996 1997, 141-145. WHO Weekly Epidemiological Record 72.
2. Wolter T., Richter A. Assays for controlling host-cell impurities in biopharmaceuticals. BioProcess International 2005, 3(2):2-6. February.
3. Verado M., Carvalho J., Delgado D., Kuhns S. Accuracy and sensitivity of residual DNA detection by QPCR is not predicted by target copy number 2011, November, online publication.
4. Venable D., Miro-Quesada G., Calley J., Monson E., He L. High-throughput and quantitative detection of residual NS0 and CHO host cell genomic DNA. BioProcess International 2007, 5(6):56-61. June.
5. Haynes S.R., Toomey T.P., Leinwand L., Jelinek W.R. The Chinese hamster Alu-equivalent sequence: a conserved highly repetitious, interspersed deoxyribonucleic acid sequence in mammals has a structure suggestive of a transposable element. Molecular and Cellular Biology 1981, 1(7):573-583.
6. International Conference of Harmonization Q2(R1) Validation of Analytical Procedures, Text and Methodology, June 1995.