Determination of Enzyme Activity

GLP and GMP certified enzyme activity assays for natural and engineered enzymes, enzymatic biomarkers, and enzyme inhibitors.

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:

  • Therapeutic enzymes
  • Enzyme-inhibitors

  • Enzyme and protein research in need of drug-level quantification and enzyme kinetics.

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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.
Bioequivalence studies

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

Services

Related services to Determination of Enzyme Activity

Sample preparation biology bioanalytics

Bioanalysis of Biologics and Biosimilars

Method development and validation and sample measurement of biologics and biosimilars.

Analytisches CRO HPLCs

Batch Testing and Batch Release

KYMOS is GMP certified and we have a partial manufacturer authorization for Quality Control purposes.

Bioequivalence studies

Quality Control of Biologics and Biosimilars

Complex characterization projects for innovative biologics and comparison of biosimilars.

BSL2 testing room

Cell-Based and Potency Assays

We offer GLP Cell-based neutralizing antibody assays for biologics and GMP Cell-based potency assays for vacines and other biologics.

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