Argos Therapeutics and Eurofins Lancaster Laboratories (ELL) have received regulatory approval from authorities in the U.S., UK, Canada, Czech Republic and Israel for rapid mycoplasma testing of an autologous cell-based therapy produced by Argos.
ELL validated the use of the MilliPROBE system, marketed by EMD Millipore, to test samples of the autologous immunotherapy currently in clinical trials for renal cell carcinoma. The assay can deliver same-day preliminary results compared to 28 days required for the standard compendial method, eliminating the need to conditionally release cell-based products that require rapid turnaround time.
“Mycoplasma contamination of cell lines used to produce biopharma products can disrupt cellular growth and metabolism and alter gene expression, leading to decreased product quantity and quality,” says Jeri Ann Boose, Ph.D., director of Biopharmaceutical Services at Eurofins Lancaster Laboratories. “World-wide regulatory agencies require that products produced in cell substrates be tested to ensure the absence of mycoplasma contamination. The compendial method requires 28 days and is therefore not suitable for obtaining the rapid lot release testing results needed for products that have short half-lives or for which there is high market demand.”
The MilliPROBE system uses Real-Time Transcription-Mediated Amplification (TMA) technology to detect targeted microbial contamination within hours compared to the weeks usually required to generate results using traditional culture-based technology. The MilliPROBE assay probe system was designed by sequence analysis to detect Mycoplasma, Spiroplasma and Acholeplasma using a multiplex of conserved rRNA sequences in non-clinical applications.