Overcoming Mycoplasma Testing Challenges in Cell and gene Therapy Manufacturing with BIOFIRE®
Testing for mycoplasma contamination is a required release test for Cell & Gene Therapy products (CGT). Compendial methods require 28 days of testing and are therefore not suitable for short shelf-life products – moreover, CGT product sample availability for carrying out the test is also a limiting factor to be considered.
The BIOFIRE® Mycoplasma test is a closed-system sample-to-answer nucleic acid test that is designed to report the presence/absence of over 130 mycoplasma species in less than an hour. It requires minimal hands-on time and contains everything needed to run a molecular test in a sealed pouch. The simplicity and ease of use of BIOFIRE® Mycoplasma allows anyone to perform the test anywhere at any time reducing labor requirements and minimizing the risk of errors: saving time and money.
This white paper presents a new sample pre-processing protocol that requires a limited amount of test product and allows the inclusion of mammalian cells. This new protocol provides the required performance to be used as a release test with a sensitivity <10 CFU/ml. Addressing these critical needs of CGT manufacturers makes the BIOFIRE® Mycoplasma test well suited for fast & easy mycoplasma release in this rapidly growing industry.
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