[Mycoplasma Testing] Rapid Detection Accelerates Biopharmaceutical Release

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1. The Prevalence and Risks of Mycoplasma Contamination

Mycoplasma contamination is a long-standing problem in cell culture and biopharmaceutical production. Mycoplasmas are widely distributed in the environment and commonly reside on human mucosal surfaces. These wall-less microorganisms are small, pleomorphic, and pathogenic, with more than 190 species identified in humans, animals, and plants. Studies indicate 15%–35% of cell cultures may be contaminated, and in some laboratories, the rate can reach up to 85%. Major contamination sources include the environment and laboratory personnel.

2. Importance of Mycoplasma Testing in Cell Therapy

Mycoplasma testing is a critical part of quality control in cell therapy research. In clinical studies, such as those involving mesenchymal stromal cells (MSCs), multiple safety checks—including mycoplasma detection—are required to ensure consistent therapeutic outcomes. Similarly, in CAR-T cell research, Mycoplasma contamination has been identified as a serious risk that can compromise cell function and treatment safety. Contaminated cells not only reduce therapeutic efficacy but may also pose risks to patient safety. Therefore, strict mycoplasma testing is indispensable, serving as a key safeguard for the quality and safety of all clinical-grade cell products.

3. The Impact of Mycoplasma Contamination

Mycoplasma contamination poses serious risks to cell cultures and biopharmaceutical production. It can cause chromosomal abnormalities, disrupt nucleic acid synthesis and metabolism, and even trigger apoptosis. In manufacturing, mycoplasma contamination lowers yields, compromises quality, and forces disposal of batches, leading to costly downtime, equipment cleaning and extended investigations. Therefore, strict testing of raw materials, culture processes, and final products is essential throughout biopharmaceutical development.

4. Limitations of Traditional Mycoplasma Detection Methods

As cell therapies continue to expand, mycoplasma testing has become a vital quality control step. Traditional methods—such as culture assays, indicator cell assays, and polymerase chain reaction (PCR) testing—pose significant challenges. Culture assays can take up to 28 days and have variable sensitivity, while indicator assays also present inherent limitations. For the biopharmaceutical industry, where rapid product release is critical, these traditional approaches are often insufficient.

5. Advantages of Rapid Detection Technologies

Rapid nucleic acid amplification technologies, such as quantitative real-time PCR (qPCR), help overcome the limitations of traditional mycoplasma testing. qPCR enables accurate detection within a short timeframe, improving efficiency while offering high sensitivity, specificity, and cost-effectiveness, making it well-suited for laboratory workflows. However, it cannot distinguish live from dead mycoplasma, requires optimized experimental conditions, and must be paired with appropriate controls to minimize false positives or negatives.

Validation Data

• High Sensitivity: Meets regulatory standards (10 CFU/mL).

Tested 10 mycoplasma standards (10 CFU/mL) in 24 replicates each; all returned positive—meeting/exceeding EP 2.6.7 standards (10 CFU/mL).

• Broad Coverage: Detects over 250 species of Mycoplasma and Mollicutes.

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Upcoming Mycoplasma Detection Insights Series！

Part 1: Mycoplasma Detection: A Critical Defense for Ensuring Biopharmaceutical Quality

Part 2: Key Points and Accurate Workflow for Rapid Release Testing

Part 3: [Mycoplasma Testing] Rapid Detection Accelerates Biopharmaceutical Release

Part 4: Overcoming Detection Challenges: From Traditional to Rapid Testing

Part 5: Ensuring Sample Purity: Case Studies & Best Practices

Part 6: Entering the Era of Precision Detection: Innovations and Applications

Part 7: Regulatory Excellence: Compliance & Industry Standards for Rapid Testing