Kymos Group provides enzymatic activity assays under GLP/GMP conditions in both bioanalytical and CMC projects. We support the determination of enzymatic activity for natural and engineered enzymes, enzymatic biomarkers, and enzyme inhibitors in biological and pharmaceutical formulations.
By combining our deep scientific expertise with extensive regulatory experience, we ensure reliable, validated results and offer services for:
Our methodology
We determine enzyme activity by providing a synthetic substrate to the enzyme and measuring product formation and turnover rate using microtiter plate readers. We employ absorbance, luminescence, or fluorescence detection, depending on the specific enzyme assay application.
Our capabilities include:
- Kinetic measurements of enzymatic activity
- Enzyme-substrate specificity analyses
- Inhibitor efficacy and reversibility screenings
- Development of customized enzyme activity assays for novel therapeutic targets
This versatile approach allows us to handle enzyme activity tests for standard biomolecules and specialized enzyme characterization studies required for innovative drug pipelines.
Bioanalysis by Enzymatic Activity
We perform GLP-certified enzymatic activity determination in biological matrices 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.
This flexibility ensures that we can meet a wide range of bioanalytical and regulatory needs for therapeutic enzymes, enzyme inhibitors, and biologics.
CMC of Enzyme-based drugs and QC Enzymatic Assays
Kymos offers GMP-certified Quality Control services and CMC studies for enzyme-based drugs and enzyme inhibitors. Our portfolio includes:
- Bioassay and biological potency determination
- Stability studies under ICH conditions
- Batch release testing and method validation
Our enzyme testing services follow Pharmacopoeial methods (Ph. Eur., USP) when available or are developed and validated according to ICH guidelines. This ensures our clients receive robust, regulatory-compliant results for global submissions.
Our Range of Enzymes and Applications
At Kymos, we perform enzyme activity assays across a diverse range of enzymes and therapeutic applications. Our experience includes:
- Proteases (e.g., trypsin, pepsin, serine proteases, carboxypeptidase)
- Lipases and esterases for metabolic and formulation studies (e.g., phospholipase, colipase, cholesterol esterase)
- Glycosidases such as amylase, lysozyme, cellulase, and lactase
Our team develops and validates tailored enzymatic assays and enzyme kinetic assays for innovative molecules, ensuring high sensitivity and compliance with regulatory requirements for bioanalytical and CMC studies.
Whether you require a protease activity assay, lipase activity assay, or highly specialized enzyme characterization, we provide precise and reliable data to advance your drug development.
Why Choose KYMOS?
Services
Related services to Determination of Enzyme Activity
Bioanalysis of Biologics and Biosimilars
Method development and validation and sample measurement of biologics and biosimilars.
Batch Testing and Batch Release
KYMOS is GMP certified and we have a partial manufacturer authorization for Quality Control purposes.
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