Multiplex RT Q-PCR assay for simultaneous quantification of three viruses used for validation of virus clearance by biopharmaceutical production.

Lute, Scott; Wang, Hua; Sanchez, Davonie; Barletta, Janet; Chen, Qi; Brorson, Kurt

Lute, Scott; Wang, Hua; Sanchez, Davonie; Barletta, Janet; Chen, Qi; Brorson, Kurt.

Affiliation

Lute S; Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, USA. scott.lute@fda.hhs.gov

Biologicals ; 37(5): 331-7, 2009 Oct.

Article in En | MEDLINE | ID: mdl-19683941

Subject(s)

Biopharmaceutics/standards; DNA, Viral/analysis; Pharmaceutical Preparations/chemistry; Reverse Transcriptase Polymerase Chain Reaction/methods; Virus Inactivation; Animals; Biopharmaceutics/methods; Drug Contamination/prevention & control; Gene Dosage; Genome, Viral; Leukemia Virus, Murine/genetics; Leukemia Virus, Murine/isolation & purification; Minute Virus of Mice/genetics; Minute Virus of Mice/isolation & purification; Reverse Transcriptase Polymerase Chain Reaction/standards; Sensitivity and Specificity; Simian virus 40/genetics; Simian virus 40/isolation & purification; Virus Inactivation/drug effects; Viruses/genetics; Viruses/isolation & purification

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Full text: 1 Collection: 01-internacional Database: MEDLINE Main subject: Biopharmaceutics / DNA, Viral / Pharmaceutical Preparations / Reverse Transcriptase Polymerase Chain Reaction / Virus Inactivation Type of study: Diagnostic_studies / Prognostic_studies Limits: Animals Language: En Journal: Biologicals Journal subject: ALERGIA E IMUNOLOGIA Year: 2009 Document type: Article Affiliation country: United States Country of publication: United kingdom

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