BIOFIRE® - Accelerate and secure mycoplasma detection

Mycoplasma contamination is a critical issue in the biopharmaceutical industry, particularly for Cell & Gene Therapies (CGT). Invisible under the microscope and resistant to conventional antibiotics, these contaminants can:

•  Compromise of biomedicines safety

• Affect therapeutic cells viability  

• Cause critical delays in production and clinical trials

At Clean Cells in collaboration with bioMérieux, we have integrated BIOFIRE®, a rapid multiplex PCR technology, enabling highly reliable detection within hours. This solution represents a major breakthrough for developers of advanced therapies, offering a robust and validated alternative to compendial methods, which take several weeks to obtain a result.

Why choose BIOFIRE® & Clean Cells ? 

With over 25 years’ expertise in mycoplasma quality control, Clean Cells is a trusted partner in the biopharmaceutical industry. We support many laboratories, CDMOs and pharmaceutical manufacturers in the evaluation and control of mycoplasma risk, applying methods recognized and validated by international pharmacopoeias (US (USP <63>), European (EP 2.6.7) & Japanese Pharmacopeias (JP 17)). 

Today, we combine this historical expertise with BIOFIRE®, delivering reliable & fast detection that meets GMP regulatory requirements, optimizing mycoplasma controls with: 

• Significant time savings: Results in few hours, compared to several weeks with compendial culture. 

• Greater reliability: High sensitivity and specificity, detecting mycoplasma at very low concentrations. 

• Reduced analytical risks: Mitigate interference and enhance reproducibility of results. 

• Low sample volumes requirements: Ideal for cell and gene therapy, where products quantities are limited and highly valuable. 

• Implementation flexibility: BIOFIRE® available as a service or integrated directly into your laboratory. 

As a recognized expert in microbiological quality control, Clean Cells offers cutting-edge mycoplasma detection through our strategic partnership with bioMérieux,. With technology and expertise combined, we provide the most advanced & compliant solution for securing your biologics.