Determination of ENZYME ACTIVITY

Kymos provides enzyme activity 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. The service targets developers of therapeutic enzymes, enzyme-inhibiting agents or enzyme and protein researchers in need of drug level quantification and enzyme kinetics. Enzyme activity levels are determined 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
Enzyme Activity Assays

This enzyme activity assay format was 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

Both enzyme activity assay formats can use the signal of the produced product or substrate digestion for quantification. Calibration curves with the product or substrate or the enzyme velocity can be used for determination of the enzyme activity. The enzyme activity is divided into the specific activity (units/mg) and volume activity (units/ml). One unit is in general defined as 1 µmol substrate turn over per minute.

Enzyme Determination

DO YOU NEED MORE INFORMATION OR A QUOTE?

Related Services

Bioanalysis of Biologics and Biosimilars

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

Quality Control of Small Molecules

Analytical tests for APIs, excipients, intermediate products, finished products, packaging materials and process environment samples.

Quality Control of Biologics and Biosimilars

Complex characterization projects for innovative biologics and comparison of biosimilars.

Batch Testing and Batch Release

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

Get in touch


    EU Sites

    Kymos Group

    Barcelona
    Spain

    Prolytic

    Frankfurt
    Germany

    Pharmaprogress

    Ancona
    Italy

    EU Offices

    Paris
    France

    Basel
    Switzerland

    Milano
    Italy