Evaluation of MycoSEQ Plus Method for Rapid Mycoplasma Contamination Detection: Poster presented at PDA Microbiology...

Testing for mycoplasma contamination in cell banks and bioreactor cell cultures is a regulatory requirement for production of biological products. The compendial tests for mycoplasma detection require 14-28 days incubation, imposing a limitation on batch release timelines and rapid containment in the event of a contamination. The alternative rapid PCR-based mycoplasma detection kit, MycoSEQ Plus, provides results within a few hours and meets regulatory guidelines regarding sensitivity (10 CFU/mL or the genomic equivalent of 10 GC/mL) and specificity as outlined in the European Pharmacopoeia (E.P. 2.6.7, 2007), US Pharmacopoeia (US63), and Japanese Pharmacopoeia. This presentation will discuss the evaluation of the kit's performance by testing its specificity, robustness, and limit of detection.