Because it is freeze-dried, it is less affected by temperature, achieving top-notch performance and stability!
The "Cyclus RT-qPCR Mycoplasma" assay is an RT-qPCR kit designed for the rapid and highly sensitive detection of Mycoplasma, Acholeplasma, and Spiroplasma in cell cultures, biopharmaceuticals, and advanced therapy medicinal products (ATMPs). It complies with the revised European Pharmacopoeia Chapter 2.6.7 "Mycoplasma" (12.2). When used in combination with the Cyclus Bead Extraction kit and Cyclus 10 CFU/100 GC standard, it provides a reliable, pharmacopoeia-compliant solution suitable for routine quality control and method validation. 【Advantages (partial)】 ■ Results in just a few hours ■ Sensitivity compliant with EP2.6.7 (12.2) ■ Detection of DNA and RNA with RT-PCR to maximize sensitivity ■ No need for freezing or dry ice transport due to lyophilized reagents *For more details, please download the PDF or feel free to contact us.
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【Other Benefits (Partial)】 ■ Internal controls can be added before extraction, allowing monitoring of the entire workflow's inhibition. ■ Primary validation is conducted using live bacterial mycoplasma, supporting product-specific validation with Cyclus 10 CFU and 100 GC standard samples. ■ Compatible with the Cyclus Bead Extraction kit for (high-throughput) manual or automated workflows. ■ Achieves high specificity and clear signal separation with TaqMan probes. *For more details, please download the PDF or feel free to contact us.
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【Application】 ■ In-process testing and shipment testing of biopharmaceuticals derived from cell culture ■ Quality control (QC) of viral vectors, vaccines, recombinant proteins, and ATMPs ■ Mycoplasma testing of master cell banks/working cell banks and manufacturing cultures ■ Specific validation using NAT methods based on EP 2.6.7, JP 18th Revision G3, and USP *For more details, please download the PDF or feel free to contact us.
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Sartorius is a leading global company that contributes to biopharmaceutical research and the biopharmaceutical industry, established in 1870. Sartorius's laboratory products/services division meets the needs of researchers and technicians engaged in research and development and quality control in the medical industry and various other sectors by providing innovative laboratory equipment and consumables. Our products and technologies are designed to simplify our customers' operations and contribute to accelerating research and improving operational efficiency. *Biotechnology-related products can be found at the following URL: https://premium.ipros.jp/sartorius-stedim/
