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Solutions for
microbial contamination test
in biopharmaceuticals

Products for microbial contamination control in the biopharmaceutical industry

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 and PCR technologies. 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.


Sensitive Mycoplasma Detection Kit

Shimadzu Diagnostics Corporation has developed a mycoplasma detection kit, MycoFinder, that has been validated in accordance with the International Pharmacopeial recommendations (EP 2.6.7, JP 17 and USP 63) and is now commercially available throughout Europe, Middle East, and Africa.

MycoFinder uses real-time fluorescent PCR to ensure sensitive mycoplasma detection (below 10 CFU/mL).

The kit is simple and quick to implement in laboratories where time is of the essence for the release of batches of cell culture-derived biologics and Advanced Therapy Medicines (ATMPs). All components of the Master Mix are freeze-dried in each PCR tube, allowing preparation of PCR reactions in minutes.

SimplePrep® DNA extraction

Automated Nucleic Acid Extraction

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.

Any questions?

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for all our food and pharmaceuticals contamination detection kits.

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