| Article ID | Journal | Published Year | Pages | File Type |
|---|---|---|---|---|
| 8369185 | Biologicals | 2017 | 8 Pages |
Abstract
Here, we summarize the validation of the CytoInspect⢠method according to current pharmacopeia requirements. Validation of the robustness, sensitivity (at least 10 colony forming units/ml) and specificity of the CytoInspect⢠method are demonstrated. Likewise, a comparability study was performed to compare the LOD for CytoInspect⢠compared with the previously validated LOD for compendial culture tests.
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Authors
Eric Abachin, Marine Marius, Stéphanie Falque, Julien Arnaud, Valérie Detrez, Sandy Imbert, Laurent Mallet, Thierry Bonnevay,