Validation of a NAT-based Mycoplasma assay according European Pharmacopoiea

Biologicals

Volumn 38, Issue 2, 2010, Pages 238-248

  Deutschmann, Sven M ^a   Kavermann, Holger ^a   Knack, Yvonne ^a  

^a ROCHE DIAGNOSTICS GMBH   (Germany)

Author keywords

Biological production; European Pharmacopoiea Chapter 2.6.7; Mycoplasma detection; PCR; Validation

Indexed keywords

BACTERIAL DNA;

AMPLICON; ANIMAL CELL; ARTICLE; BACTERIUM DETECTION; BIOREACTOR; CELL CULTURE; CHO CELL; COLONY FORMING UNIT; CONTROLLED STUDY; DOWNSTREAM PROCESSING; FEMALE; GENE EXPRESSION SYSTEM; MOLLICUTES; MYCOPLASMA; NONHUMAN; NUCLEIC ACID AMPLIFICATION; POLYACRYLAMIDE GEL ELECTROPHORESIS; POLYMERASE CHAIN REACTION; PRIORITY JOURNAL; SENSITIVITY AND SPECIFICITY; VALIDATION PROCESS;

ALGORITHMS; ANIMALS; BACTERIOLOGICAL TECHNIQUES; CHO CELLS; CRICETINAE; CRICETULUS; CULTURE MEDIA; DNA, BACTERIAL; EUROPE; HUMANS; LIMIT OF DETECTION; MYCOPLASMA; MYCOPLASMA INFECTIONS; PHARMACOPOEIAS AS TOPIC; POLYMERASE CHAIN REACTION; REAGENT KITS, DIAGNOSTIC; RNA, RIBOSOMAL, 16S; SENSITIVITY AND SPECIFICITY;

EUKARYOTA; MOLLICUTES; MYCOPLASMA; MYCOPLASMATALES;

EID: 77950689036     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2009.11.004     Document Type: Article

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