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COMPLEX TESTING MADE SIMPLE

Mycoplasma Testing

With minimal hands-on time and fast time-to-result, BIOFIRE® Mycoplasma system makes it easy to quickly test at any point in the manufacturing process. Now, testing can be done by anyone, anywhere, at any time.

Easy In-Process Testing

Our fully automated BIOFIRE® Mycoplasma system consists of two components—the FilmArray® instrument and the single-use “molecular lab in a pouch” disposable. With just these two items, you have everything you need for fast, accurate mycoplasma testing for use along the entire production chain. To simplify the process further, we offer validation services designed to meet regulatory requirements—from documentation to comprehensive on-site support.

Product List

  • BIOFIRE® Mycoplasma

    Rapid Testing by Anyone, Anywhere, Anytime

    BIOFIRE® Mycoplasma provides simple, accurate, and rapid in-house mycoplasma detection for use in testing raw materials, in-process samples, and final product release. We offer validation services designed to meet regulatory requirements—from documentation to comprehensive on-site support.
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  • Feasibility Study

    Quickly Confirm Your Product Compatibility and Method

    A feasibility study is probably the single most important consideration when it comes to changing your method of application. Saving you time, resources, and energy, it’s a vital aspect of ensuring compatibility.
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  • Validation Protocols

    Expedite Implementation of Your Investment by Reducing Validation Time and Expense

    Managing validation plans across multiple facilities is nothing less than an art form. Whether you are implementing in-process testing solutions within your laboratory or on your production floor, you can rest assured that with ourvalidation services, all regulatory standards of local and international pharmacopeias will be fully upheld.
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Related Resources

ON DEMAND: MYCOPLASMA TESTING: AN AUTOMATED ALTERNATIVE TO TRADITIONAL NAT METHODS

The standard test for mycoplasma contamination is evolving. As macromolecule drugs derived from mammalian cells become more commonplace, reducing the turnaround time for testing has become essential for manufacturers to ensure productivity.

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MYCOPLASMA TESTING: PAST, CURRENT, AND FUTURE STATE

For nearly 30 years, mycoplasma testing for biologics has been performed using cell culture-based methods. The compendial mycoplasma detection method has been the gold standard in the biopharma industry.

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PERFORMANCE EVALUATION OF A RAPID FULLY AUTOMATED MYCOPLASMA DETECTION SYSTEM

The BIOFIRE® Mycoplasma Panel is a closed and fully automated “lab in a pouch” system that provides highly sensitive and broad detection of Mollicutes with less than five minutes of hands-on time. The disposable reagent pouch integrates nucleic acid purification and nested multiplex real-time PCR with less than one hour of run time and requires minimal training and skill to operate.

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