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.
- Features
- Tests
- Downloads
- Videos
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
Main Benefits
- 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
Support
- 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
- IOPQ validation support
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
Downloads
BIOFIRE® Mycoplasma (Brochure)
Download
- Filename
- 8.5x11_BMX_Mycoplasma_Brochure_US_Web_V17.pdf
- Size
- 276 KB
- Format
- application/pdf
Cell and Gene Therapy Testing (Brochure)
Download
- Filename
- 060730 Rev 01.A - Cell and Gene Therapy Brochure - Final Art.pdf
- Size
- 803 KB
- Format
- application/pdf
Automated 1-Hour Mycoplasma Testing in Bioproduction (White Paper)
Download
- Filename
- BIOFIRE MYCOPLASMA TESTING BIOPRODUCTION JAN 23.pdf.coredownload.pdf
- Size
- 5 MB
- Format
- application/pdf
Easy 1-Hour Mycoplasma Detection in Cell Therapy Samples (White Paper)
Download
- Filename
- Whitepaper MYCOPLASMA DETECTION IN CELL THERAPY SAMPLES AABB .pdf.coredownload.pdf
- Size
- 1 MB
- Format
- application/pdf
BIOFIRE® Mycoplasma Solution (Whitepaper)
Download
- Filename
- BIOFIRE Mycoplasma Solution.pdf
- Size
- 548 KB
- 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
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