Quantitative competitive reverse transcription-PCR as a method to evaluate retrovirus removal during chromatography procedures

Chinese hamster ovary cells used for pharmaceutical protein production express non-infectious retrovirus-like particles. To assure the safety of pharmaceutical proteins, validation of the ability of manufacturing process to clear retrovirus-like particles is required for product registration. Xenotr...

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Veröffentlicht in:	Journal of biotechnology 1999-10, Vol.75 (2), p.105-115
Hauptverfasser:	Lau, Allen S.L, Lie, Yolanda S, Norling, Lenore A, Sernatinger, Judith, Dinowitz, Marshall, Petropoulos, Christos J, Xu, Yuan
Format:	Artikel
Sprache:	eng
Schlagworte:	Animals Base Sequence Bioassay Biological and medical sciences Biotechnology CHO Cells - virology Chromatography Chromatography - methods Competitive reference standard RNA Cricetinae Cricetulus Drug products Fundamental and applied biological sciences. Psychology Health. Pharmaceutical industry Industrial applications and implications. Economical aspects Leukemia Virus, Murine - genetics Leukemia Virus, Murine - isolation & purification Molecular Sequence Data Murine leukemia virus Other active biomolecules pH effects Production of active biomolecules Proteins Quantitative competitive reverse transcription PCR Retroviridae - genetics Retroviridae - isolation & purification Retrovirus Reverse Transcriptase Polymerase Chain Reaction - methods RNA RNA, Viral - analysis Virus clearance Viruses Xenotropic murine leukemia virus
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Zusammenfassung:	Chinese hamster ovary cells used for pharmaceutical protein production express non-infectious retrovirus-like particles. To assure the safety of pharmaceutical proteins, validation of the ability of manufacturing process to clear retrovirus-like particles is required for product registration. Xenotropic murine leukemia virus (X-MuLV) is often used as a model virus for validation studies. Some chromatography procedures used for pharmaceutical protein purification utilize low pH (
ISSN:	0168-1656 1873-4863
DOI:	10.1016/S0168-1656(99)00152-2