Mycoplasma contamination is one of the most critical and insidious risks affecting bioproduction today. Difficult to detect and capable of silently altering cell physiology, productivity, and critical quality attributes, mycoplasmas can compromise product quality, patient safety, and the integrity of non-clinical and clinical data. Their impact extends across all biologics, from vaccines and recombinant proteins to advanced therapy medicinal products.
In response to this pervasive risk, regulatory authorities worldwide have established stringent requirements, reflected in more than 40 regulatory and pharmacopoeial texts governing mycoplasma detection. Recent updates to key references, including the European Pharmacopoeia chapter 2.6.7, further reinforce expectations for robust, compliant, and risk-based control strategies throughout the biologics lifecycle. In this evolving landscape,
modern mycoplasma detection has become a strategic safeguard essential to protecting bioproduction processes, ensuring patient safety, and supporting regulatory approval on a global scale.
