Mycoplasma Release Test With Low Volume Protocol: From Sample to Results in Less Than 1-Hour

Introduction

Testing for mycoplasma contamination is a required release test for Cell and Gene Therapy (CGT) products as specified in the USP, EP and JP(1-3). Current compendial methods require 28 days of testing to generate results and are not suitable for short shelf-life products. Alternative nucleic acid test (NAT) methods are available and can reduce the time to results to hours instead of days.

This poster presents a study on the performance of the new Low Volume protocol evaluated by the BIOFIRE® FILMARRAY® 2.0 Industry System.

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BIOFIRE^® Mycoplasma

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.

White Paper

Easy 1 Hour Mycoplasma Detection in Cell Therapy Samples

Various pharmacopoeias, including the USP, specify a test for mycoplasma contamination must be performed as part of the release testing of a product manufactured in the presence of eukaryotic cells (1).

Poster

Automated Nucleic Acid Amplification Assay for Mycoplasma Detection in Cell and Gene Therapy Products

Cell and gene therapies (C&GT) or Advanced Therapeutic Medicinal Products (ATMP) are innovative medicine developed to treat cancers, rare diseases, autoimmune disorders, and injuries. As these therapies utilize living cells, they produce a product with a short shelf life. While microbiological examination of cell-based products is critical to ensure patient safety, challenges exist to enable testing and obtaining rapid results prior to patient infusion.