Evaluation of BIOFIRE Mycoplasma Technology

This white paper evaluates bioMérieux’s BIOFIRE® Mycoplasma technology for testing cell and gene therapy products. It addresses the challenges associated with traditional mycoplasma testing methods, which require large sample volumes and long turnaround times, often ranging from 14 to 28 days. The paper outlines the need for rapid mycoplasma detection to ensure the safety and integrity of cell and gene therapies, which are critical in biopharmaceutical manufacturing. The BIOFIRE® Mycoplasma system is presented as a robust solution that offers rapid detection of over 130 mycoplasma species with minimal hands-on time and training required. The study details the methodology used in evaluating the system, including tests with various cell and gene therapy-related sample matrices. Results confirm the system's reliability and compliance with established pharmacopoeia guidelines. The paper concludes with discussions on potential future directions for improving mycoplasma detection techniques in the context of regulatory requirements and patient safety.