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 advantages for the biopharmaceutical industry, mainly with respect to reduced turnaround time for results, and potentially lowered cost. Replacement or substitution of existing methods by a PCR method requires the demonstration of equivalent assay limit of detection (LOD) and specificity.