Automated 1-Hour Mycoplasma Testing in Bioproduction
As presented at the 2021 PDA Conference, the data summarized in this white paper comes from four bioproduction manufacturers that evaluated the BIOFIRE® FILMARRAY® 2.0 system. Samples were evaluated with up to nine compendial mycoplasma species in the presence of high-density monoclonal antibody producing Chinese hamster ovary (CHO) cells. Studies were designed to assess product interference (false-positive rates) and detection (false-negative rates), including level of detection (LOD). Two distinct protocols were evaluated: a protocol using 10 mL of product sample that provides the sensitivity for release testing, and a direct-test protocol using 0.2 mL product sample that allows for at-line in-process control testing.
The results from these independent evaluators show that the BIOFIRE FILMARRAY 2.0 system is well-suited as both a release test or as an in-process control test for high-density CHO cell samples. The studies showed no product interference and high sensitivity providing reliable mycoplasma results in less than 1 hour. With a faster and easier approach to mycoplasma testing offered by BIOFIRE, bioproduction manufacturers can save time and reduce costs while ensuring quality.
Download the full white paper for a summary of the data and to learn how you can enable rapid, easy mycoplasma testing in-house.