Argos Therapeutics earns global regulatory approval with Eurofins Lancaster Labs’ rapid mycoplasma MilliPROBE® assay
Argos Therapeutics and Eurofins Lancaster Laboratories have announced regulatory approval from authorities in the US, UK, Canada, Czech Republic and Israel for rapid mycoplasma testing of an autologous cell-based therapy produced by Argos.
Eurofins Lancaster Laboratories validated the use of the EMD Millipore MilliPROBE® system 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, thereby eliminating the need to conditionally release cell-based products that require rapid turnaround time.
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. Faster detection allows biopharmaceutical manufacturers to take corrective action earlier in the production process, which reduces downstream processing risks, optimizes product yields and improves final product quality. 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. EMD Millipore has validated the nonclinical specificity and sensitivity of the system using 13 key mycoplasma species, which include the eight species specified in EP 2.6.7.
“In addition to accelerating time to results, the MilliPROBE® system validated by Eurofins Lancaster Laboratories offers other important benefits,” described Fran Hutson, head of Bio-Monitoring North America sales and marketing, EMD Millipore. “The system can process up to 20 mL of a sample, making it preferable to PCR and RTPCR methods typically limited to testing sample volumes that are 1-2 mL. The membrane-based sample preparation device effectively removes inhibitory substances that can interfere with nucleic acid amplification technologies.”