Fast Track NAT-Based Mycoplasma And Spiroplasma Testing Using dPCR

Mycoplasmas are among the most persistent threats in biopharmaceutical production, often remaining undetected due to their small size and lack of typical contamination signs. Because they can bypass standard sterilization filters and remain invisible under light microscopy, these contaminants frequently lead to substantial production losses. Traditional compendial testing methods are often hindered by lengthy 28-day incubation periods or insufficient sensitivity.

Digital PCR (dPCR) offers a modernized alternative, reducing testing turnaround times to just a single day while maintaining a high sensitivity of less than 10 CFU/ml. This nucleic acid amplification technique (NAT) can detect over 124 mycoplasma species, including non-cultivable strains that traditional methods miss. Such rapid, accurate detection is essential for short shelf-life products like ATMPs. Implementing these high-sensitivity assays ensures full regulatory compliance with global pharmacopoeias while accelerating contamination responses.