Shimadzu Diagnostics Europe

Exhibitor

Shimadzu Diagnostics Europe commercialises microbial contamination test kits for pharmaceutical quality control and batch release. This includes a dedicated platform for mycoplasma testing, using nucleic acid technologies, for QC in the research and production of biopharmaceuticals and Advanced Therapy Medicinal Products (ATMPs).

We offer analytical solutions for microbiological quality control by developing high performance DNA extraction (SimplePrep SPX) and PCR technologies (MycoFinder). Our solutions provide rapid and sensitive detection of microbial contaminants in line with the strict safety standards of the International Pharmacopeias and the challenging time constrains to take ATMPs from production to patient.

SimplePrep® (SPX) DNA extraction is an all-in-one automated cell lysis and nucleic acid extraction prep station designed to rapidly isolate nucleic acid from complex sample matrices in 15 to 30 minutes. Sample preparation is carried out within a versatile, disposable all-in-one extraction cartridge which performs all steps of sample lysis, nucleic acid extraction and purification automatically.
The cartridge system provides a genuine hands-free workflow for 1 to 8 samples in parallel to give high quality nucleic acid for qPCR or sequencing. Once the sample is loaded on the cartridge each step of extraction and purification is carried out automatically without end user intervention. Different pre-loaded DNA extraction protocols are controlled using a simple touch-screen interface to process different sample types within the same disposable cartridge.

MycoFinder is a Real-Time PCR cell culture contamination detection kit that provides a sensitive, rapid, reliable, and cost-effective solution for the quality control of Advanced Therapy Medicinal Products (ATMPs) and biopharmaceuticals.
MycoFinder rapid mycoplasma cell culture contamination detection kit, has been validated in accordance with the EP 2.6.7, USP 63 and JP 17 and is available throughout EMEA.
MycoFinder uses real-time fluorescent PCR to ensure sensitive mycoplasma detection (below 10 CFU/mL). The kit is simple and quick to implement for product screening and batch release in laboratories where time is of the essence.



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