Testing Bioproduction Samples
Using the BIOFIRE Mycoplasma Molecular Lab in a Pouch System
2021 PDA PHARMACEUTICAL MICROBIOLOGY VIRTUAL CONFERENCE, OCTOBER 4-6, 2021
This poster presents results from independent studies performed by 4 bioproduction companies using the BIOFIRE® Mycoplasma system that can detect >130 species of mycoplasma
The BIOFIRE® filmarray system condenses all the steps of a conventional PCR test into an enclosed pouch and provides sample to answer in less than one hour with as little as 2 minutes of hands-on time.
The studies performed and summarized in this poster used the following protocols:
- Direct test protocol for in-process control testing utilizing 0.2 mL of sample (LOD less than or equal to 30 cfu/mL)
- Release test protocol the concentrates the sample with centrifugation utilizing 10 mL of sample (LOD less than or equal to 10 cfu/mL)
The evaluators tested a variety of sample types including high density CHO cells up to 107/mL with and without inoculated mycoplasma.
Regardless of the protocol tested there were no false positive results reported when testing product samples in the absence of mycoplasma.
The results showed 100% detection of inoculated samples at target inoculum levels for both the 0.2 mL direct test protocol and the 10 mL release test protocol.
These studies show that the BIOFIRE® Mycoplasma System is well suited as both a release test or as an at-line in-process control test for high density CHO cell samples.
The results showed no product interference and high sensitivity providing reliable mycoplasma results in less than 1 hour with little technical training needed.
- Lori Daane, Ph.D., bioMérieux
Complete the form below to access the poster, which will be sent directly to your email after submission. By providing your information, you agree to receive additional emails from bioMérieux about mycoplasma testing.
To find out more about the management of your personal data and to exercise your rights, see our privacy policy.
