MycoFinder kit successfully completes EP 2.6.7 validation study
Nissui Pharma Solutions (NPS) has successfully completed an EP validation study in partnership with Confarma, a Solvias group company, specialized in biological analysis. MycoFinder, a mycoplasma gene detection kit, fulfils all requirements for EP 2.6.7. This Real-time PCR assay is compliant in terms of Limit of Detection (LOD), specificity and robustness. In addition, MycoFinder is comparable to compendial methods (cell culture and cell indicator methods).
MycoFinder will be available in Europe from Q3 2020.
Solvias is a world leader in contract analytical and process research, development and manufacturing. More information about the Solvias group can be found on the following link: https://www.solvias.com
NPS provides innovative solutions for QC/QA and product release of ATMPs and biopharmaceuticals.
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