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Mycoplasma are unique prokaryotic microorganisms lacking a cell wall, extremely small in size (approximately 0.1–0.3 µm), capable of passing through standard filtration membranes, and inherently resistant to common antibiotics. As the smallest culturable organisms, they are notorious contaminants in cell culture, capable of depleting nutrients, altering gene expression, and affecting cellular metabolism, proliferation, and functional assays. More critically, Mycoplasma contamination can compromise experimental results, lead to biopharmaceutical development failures, and even pose risks to clinical product safety. Due to their resistance to conventional elimination methods, contamination often results in substantial financial and labor losses.
Figure 1. Various assays for mycoplasma testing.
Globally, Mycoplasma testing has become a mandatory quality control requirement in cell and gene therapy products, vaccines, biologics, and related research. Regulatory bodies such as the FDA, European Pharmacopoeia (EP), Chinese Pharmacopoeia (ChP), Japanese Pharmacopoeia (JP), and regulations like 21 CFR 610.30 mandate testing at cell bank, production, and finished product stages to ensure safety and efficacy.
Creative Biogene offers a comprehensive Mycoplasma detection platform that combines traditional gold-standard methods with cutting-edge molecular assays, delivering fast, reliable, and regulatory-compliant results.
1. Direct Culture (28-day method)
Considered the gold standard, direct culture offers sensitivity up to 0.1 cfu/mL, suitable for cell banks, bulk intermediates, and final product testing. Creative Biogene provides validated media systems and positive control strains to ensure reproducibility and reliability.
2. Indicator Cell Culture
This method uses DNA-binding dyes to visualize Mycoplasma under a microscope, providing direct evidence of infection. We optimize indicator cell selection and fluorescence interpretation to minimize false positives.
3. Nucleic Acid-Based Methods (qPCR/ddPCR)
Molecular approaches offer rapid, highly sensitive detection, with a lower limit of 10 copies of Mycoplasma DNA. Our qPCR/ddPCR platforms have been cross-validated against pharmacopoeial methods, meeting both regulatory submission and internal QC needs, particularly suitable for short shelf-life products or viral samples.
Creative Biogene's Mycoplasma testing services cover the full biopharmaceutical development lifecycle, ensuring regulatory compliance from raw materials to finished products:
| Sample Type | Application |
| Cell Banks (MCB/WCB) | Foundation for cell therapy, vaccine, and recombinant protein production |
| Raw Materials | Serum, media, and supplements are prone to contamination |
| In-Process Intermediates | Fermentation broth, viral banks, untreated bulk (UPB) |
| Finished Products | Bulk or formulated products, ensuring final product safety |
| Research Samples | Preclinical studies, QC testing, internal safety assessments |
Comprehensive monitoring reduces regulatory risks, improves R&D efficiency, and facilitates global product registration.
Mycoplasma testing is not just a QC step—it is a critical safeguard for the safety and efficacy of biopharmaceutical and cell therapy products. Creative Biogene combines global quality systems, advanced platforms, and an experienced scientific team to provide rapid, reliable, and compliant testing. From early R&D to clinical submission stages, we deliver customized solutions to accelerate your product toward the market.
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Q1: Is full-process monitoring required for Mycoplasma testing?
A1: Yes. Testing should cover raw materials, cell banks, in-process intermediates, bulk, and finished products to ensure regulatory compliance.
Q2: Do viral samples affect detection results?
A2: Some viruses may interfere with indicator cell assays. We provide viral neutralization or validated qPCR/ddPCR methods to ensure accurate results.
Q3: Can molecular method data (e.g., qPCR) be used for regulatory submissions?
A3: Yes, after comparison validation with culture methods, if equivalence or superiority is demonstrated, molecular results can be submitted for regulatory filings.
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