Kymos Group provides enzymatic activity determination assays under GLP/GMP conditions in both bioanalytical and CMC projects for natural and engineered enzymes, enzymatic biomarkers, and enzyme inhibitors in biological and formulation samples.
With our extensive experience, we can provide services for:
Our methodology
We determine enzyme activity levels by providing a synthetic substrate to the enzyme and measuring the product and turnover rate by means of a microtiter reader for absorption, luminescence, and fluorescence detection in different applications:
- Kinetic measurements of enzyme activity
- Enzyme/substrate specificity analysis
- Inhibitor efficacy and inhibition reversibility screenings
Bioanalysis by Enzymatic Activity
GLP-certified Enzymatic activity determination in biological samples for Preclinical and Clinical studies. This enzymatic activity format is adapted from EMA’s Immunological guidelines for this purpose, given the lack of specific guidelines for the determination of enzyme activity.
Enzyme-based drugs or drugs involved in enzymatic reactions are quantified by means of their biocatalytic activity in two different ways:
- Endpoint measurements: The enzyme reaction is stopped after a defined time period.
- Real-time enzyme kinetics: The enzyme reaction is monitored per time unit.
CMC of Enzyme-based drugs and QC Enzymatic Assays
GMP certified Quality Control and CMC projects for Enzyme-based and/or Enzyme Inhibitor products, and formulations:
- Bioassay/Biological Potency determination
- Stability Studies
Our methodology is based on our broad experience and know-how, enabling us to:
- Follow Pharmacopeia analytical methods (PhEur, USP)
- Development of analytical methods
- GMP Validation of analytical methods
- GMP Sample analysis and Batch testing
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