Validation of a PCR method for the detection of mycoplasmas according to European Pharmacopoeia section 2.6.7.


Recent publication of a revised section for mycoplasma testing in the European Pharmacopoeia has led to interest in validating a nucleic acid amplification technique (NAT) for use in detection of mycoplasma contaminants in biologics drugs. The replacement by or supplementation of the existing culture-based methods with a PCR-based method has several… (More)
DOI: 10.1016/j.biologicals.2009.11.003


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