Thermo Fisher mycoplasma detection tech accepted for cell therapies
The Applied Biosystems MycoSEQ Mycoplasma Detection Kit provides manufacturers of cell-culture-based therapeutics a faster method for detecting contamination, said the vendor.
The MycoSEQ assay can detect more than 90 mycoplasma species in less than five hours, offering drugmakers an alternative to “costly, time-consuming culture-based tests often done by externally contract labs, which can take up to 28 days,” the firm said.
The assay and method can be used for lot release by drugmakers of biotherapeutics, cell and gene therapies, vaccines, and other cell-culture-based medicines.
Head of pharma analytics Michael Brewer told us the technology was recently granted patents that cover its multiplexed PCR (polymerase chain reaction) primer approach and discriminatory positive/extraction control.
“These innovations to real-time PCR technology, which are unique to us, enable this rapid test for mycoplasma to meet the increasingly rigorous requirements of both regulatory authorities and manufacturers.”
Multiple pharmaceutical companies are using the assay, we were told.
“Several global manufacturers, including Vericel, across multiple therapeutic modalities have successfully validated the assay and achieved regulatory approval for lot release,” said Brewer.
The technology is available to manufacturers worldwide.