A Novel At-Line Pharmaceutical-Grade Mycoplasma Testing Solution:
Sample to Results in Less than One-Hour

August 27th, 2020 • 10 a.m. PDT, 1 p.m. EDT

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With a small footprint, two minutes hands on-time, and less than one-hour time-to-result, BIOFIRE® Mycoplasma makes it easy to quickly test diverse sample types at any point in the manufacturing process. This new “molecular lab in a pouch” fully automates the extraction, amplification, and detection steps; allowing easy implementation of at-line in-process controls to better secure the manufacturing process.

BIOFIRE's multiplex PCR-based system meets the regulatory requirements of all major pharmacopoeias for final product Mycoplasma release testing. Data integrity and traceability are assured through 21 CFR Part 11 compliant software. With BIOFIRE Mycoplasma, you no-longer have to wait days for outsourced in-process results to know your manufacturing process is on track.

After a presentation of the technology, a summary of the primary validation results will be shown, and validation data obtained from different evaluation studies realized by pharma companies on bioproduction products will be presented.

In this webinar you’ll learn about:

• How this “lab in a pouch” technology works

• Primary validation data

• Biopharmaceutical company evaluation data

Who should attend:

• Microbiology QC manager/director

• Analytical lab scientists

• Bioproduction (upstream) Manufacturing manager

• People interested in rapid mycoplasma testing


Sylvanie Cassard Guilloux
Healthcare Global Solution Manager,
View Biography
Lori Daane
Director, Healthcare Scientific Affairs,
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Mike Auerbach
American Pharmaceutical Review