商品描述
Immunologic assay for sensitive detection of the compounds of the Liberase blend
The Roche Residual Protein Liberase Kit, based on an immuno assay with tailor-made polyclonal antibodies against the components of the Liberase blend makes testing for residual Liberase fast and reliable. The assay is perfectly suited for process development, in-process control and final quality control.
Fast: Total assay time of 2-2.5 h
High sensitivity: Detection limit ≤ 0.1 ng/mL, measuring range 0.1-10 ng/mL
High specificity: Specific detection of the components of the Liberase blend (Collagenases I + II, Thermolysin) and fragments thereof by use of polyclonal antibodies
Application
This kit is intended for quantitative detection of Liberase Blends in manufacturing processes of biopharmaceutical products.
Specifications
Sensitivity: ≤0.1 ng/mL
Measuring range: 0.1 - 5 ng/mL
Precision: ≤15% (typically <5%)
Accuracy (vs. weight): ≤25%
Specificity: Roche Liberase Blends; Collagenases I and II from Clostridium histolyticum, Thermolysin from Bacillus thermopoteolyticus, and fragments
Assay time (h:min): 2 - 2:30 total assay time
Test format: 96 reactions
Regulatory Disclaimer
For quality control/manufacturing of IVD/medical devices/pharmaceutical products only.