Executive Summary
Mycoplasma contamination poses a critical safety risk in cell and gene therapy manufacturing, often requiring time-intensive testing methods that delay product release. In this white paper, Minaris Advanced Testing evaluates the BIOFIRE® Mycoplasma System from bioMérieux across multiple raw materials and drug product matrices. The system demonstrated reliable detection down to 1 CFU/mL in active cell cultures and met global regulatory expectations. Discover how rapid, sample-to-answer testing can accelerate timelines while maintaining compliance and product safety.
Key Takeaways
- Successfully detected multiple mycoplasma species across diverse CGT sample matrices
- Achieved detection at 1 CFU/mL in active cell cultures
- Met regulatory expectations for limit of detection (10 CFU/mL requirement)
- No false positives in neat samples; all spiked samples correctly identified
- Reduced turnaround time compared to traditional mycoplasma methods
Download the full white paper to explore the complete data, validation approach, and operational insights.
About This White Paper
Mycoplasma contamination remains a significant risk in cell and gene therapy (CGT) manufacturing. Traditional culture-based mycoplasma detection methods can require extended incubation periods, creating delays in product release and increasing manufacturing risk. Developers need rapid mycoplasma testing solutions that maintain sensitivity, specificity, and compliance with USP, EP, and JP regulatory guidelines.
Minaris Advanced Testing evaluated the BIOFIRE® Mycoplasma System from bioMérieux across seven representative CGT-related matrices, including critical raw materials (FBS, TrypLE™, DMEM, plasmid DNA) and drug products such as CAR-T cells. Samples were tested neat and spiked with viable mycoplasma strains (including M. hyorhinis, M. orale, and M. pneumoniae) at defined CFU concentrations. The system’s performance was assessed for sensitivity, specificity, ease of implementation, and operational robustness.
The BIOFIRE® system detected mycoplasma at concentrations as low as 1 CFU/mL in active cell cultures, meeting regulatory expectations for a 10 CFU/mL limit of detection. No mycoplasma was detected in neat samples, while all spiked samples tested positive. No invalid or inconclusive results occurred during evaluation.
Rapid, reliable mycoplasma detection can significantly accelerate product release timelines while maintaining compliance and patient safety. By integrating innovative testing platforms into operational workflows, CGT developers can reduce risk, improve scalability, and enhance readiness for clinical and commercial manufacturing.
Who should read this white paper?
- Cell therapy process development teams
- Quality control and quality assurance professionals
- CMC and regulatory affairs specialists
- Manufacturing leaders seeking faster release testing
- Developers preparing for IND or commercial readiness
