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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.

Product Details

You no longer have to send out your mycoplasma testing, wait 28 days for the compendial method, or require a molecular biologist with specialized training and a dedicated lab for a rapid result. BIOFIRE® allows you to be assured that your manufacturing process is on track by allowing nearly anyone to test for mycoplasma anywhere in the facility at any time.

Features

  • Two minutes of hands-on time
  • Fully automated
  • Go from sample to result in less than 60 minutes
  • Test raw materials, in process samples and final products
  • Detects more than 120 strains of Mycoplasma and Mollicutes
  • 21 CFR part 11 compliant
BIOFIRE® Mycoplasma and Man

Main Benefits

Support

  • Two minutes of hands-on time
  • Fully automated
  • Go from sample to result in less than 60 minutes
  • Test raw materials, in process samples and final products
  • Detects more than 120 strains of Mycoplasma and Mollicutes
  • 21 CFR part 11 compliant

Watch the video to see how this rapid PCR technology uses a "molecular lab in a pouch" to deliver at-line testing on demand.

  • FDA CBER Type V Master File available
  • FDA CDER Type V Drug Master File available
  • Method validation guidance
  • Compendial method comparability report
  • Installation, Operation and Performance Qualification support
  • Feasibility Service 

Tests

The BIOFIRE® mycoplasma system consists of two components—the FilmArray® instrument and the single-use “molecular lab in a pouch” disposable. With just two items you have everything you need for fast, accurate mycoplasma testing.

  • Cell Banks
  • In-Process Controls
  • Culture Media
  • Release Tests At The Harvest

BIOFIRE® Mycoplasma (Brochure)

Download

Filename
8.5x11_BMX_Mycoplasma_Brochure_US_Web_V17.pdf
Size
276 KB
Format
application/pdf

Automated 1-Hour Mycoplasma Testing in Bioproduction (White Paper)

Download the white paper AUTOMATED 1-HOUR MYCOPLASMA TESTING IN BIOPRODUCTION

Filename
BIOFIRE MYCOPLASMA TESTING BIOPRODUCTION JAN 23.pdf
Size
5 MB
Format
application/pdf

Easy 1-Hour Mycoplasma Detection in Cell Therapy Samples (White Paper)

Download the complete white paper "EASY 1-HOUR MYCOPLASMA DETECTION IN CELL THERAPY SAMPLES"

Filename
Whitepaper MYCOPLASMA DETECTION IN CELL THERAPY SAMPLES AABB .pdf
Size
1 MB
Format
application/pdf

bioMérieux's BIOFIRE® MYCOPLASMA is a revolutionary approach to mycoplasma testing that brings value to biopharmaceutical manufacturing.

All current rapid methods available are complicated, require a specific molecular laboratory organization, highly trained personnel and can be time consuming. The BIOFIRE® Mycoplasma solution provides results in less than 1h, is fully automated and requires only 2 minutes of hands-on-time.

Thanks to its ease-of-use and small footprint, BIOFIRE® Mycoplasma enables testing outside of the expert lab, near sample collection sites, by personnel non-specialized in mycoplasma detection.

It’s an innovation that brings massive added­-value in safeguarding bioproduction procedures, minimizing the impact of the cost of a possible contamination in the factory, and gaining valuable time in releasing batches.

The Mycoplasma Testing Revolution

Reliable, 1 hour, at line Mycoplasma testing

Complex testing made simple & accessible

Easy 3 step workflow

Molecular lab in a pouch