Validation and international regulatory experience for a mycoplasma touchdown PCR assay

Biologicals

Volumn 38, Issue 2, 2010, Pages 224-231

  Asarnow, David ^a   Warford, Ann ^b   Fernandez, Lewis ^a   Hom, Jonathan ^a   Sandhu, Gursaneep ^a   Candichoy, Zayda ^a   Luna, Geraldine ^a   Goldman, Mark ^a   Rarich, Randy ^a  

^a BAYER CORPORATION   (United States)

^b MEDIMMUNE   (United States)

Author keywords

BHK; Factor VIII; Mycoplasma; Touchdown PCR

Indexed keywords

RECOMBINANT BLOOD CLOTTING FACTOR 8; RNA 16S;

ARTICLE; BACTERIAL GENOME; BACTERIUM CULTURE; BACTERIUM DETECTION; BIOREACTOR; COLONY FORMING UNIT; CONTROLLED STUDY; CULTURE MEDIUM; ENZYME SYNTHESIS; GRAM NEGATIVE BACTERIUM; INTERMETHOD COMPARISON; MYCOPLASMA; NONHUMAN; POLYMERASE CHAIN REACTION; PRIORITY JOURNAL; SENSITIVITY AND SPECIFICITY; VALIDATION PROCESS;

ANIMALS; BACTERIOLOGICAL TECHNIQUES; BIOREACTORS; CELLS, CULTURED; CRICETINAE; DNA, BACTERIAL; DRUG CONTAMINATION; FACTOR VIII; INTERNATIONALITY; LEGISLATION, DRUG; LIMIT OF DETECTION; MYCOPLASMA; POLYMERASE CHAIN REACTION; RECOMBINANT PROTEINS; SENSITIVITY AND SPECIFICITY; SPECIES SPECIFICITY;

MYCOPLASMA; POSIBACTERIA;

EID: 77950689113     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2009.11.006     Document Type: Article

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