Mycoplasma Detection: A Critical Defense For Ensuring Biopharmaceutical Quality

Mycoplasma poses a unique challenge in biopharmaceutical production because these wall-less bacteria easily bypass standard sterile filtration. Their presence can silently alter gene expression, inhibit cell metabolism, and induce chromosomal abnormalities, potentially compromising the safety of monoclonal antibodies and advanced therapy medicinal products (ATMPs). While traditional culture-based testing remains a gold standard, the 28-day turnaround time often conflicts with the rapid manufacturing cycles required for modern cell and gene therapies.

Implementing highly sensitive nucleic acid amplification technology (NAT) allows for the detection of over 250 species within hours rather than weeks. Transitioning to these rapid methods ensures compliance with major pharmacopeias while maintaining rigorous sensitivity levels of 10 CFU/mL. Explore how these diagnostic advancements safeguard patient safety and prevent the significant economic losses associated with product recalls.