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Rapid mycoplasma MilliPROBE® assay

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Argos Therapeutics earns global regulatory approval with Eurofins Lancaster Laboratories’ 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.

Mycoplasma contamination of cell lines used to produce biopharmaceutical products can disrupt cellular growth and metabolism and alter gene expression, leading to decreased product quantity and quality. World-wide regulatory agencies require that products produced in cell substrates be tested to ensure the absence of mycoplasma contamination.

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, optimises 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 non-clinical specificity and sensitivity of the system using 13 key mycoplasma species, which include the eight species specified in EP 2.6.7 . Beyond faster results, the system can process up to 20 mL of a sample, making it preferable to PCR and RT-PCR methods typically limited to testing sample volumes that are 1-2 mL.

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