Laboratory enzyme analysis ensures the catalytic efficiency, stability, and regulatory compliance of therapeutic proteins. Essential for CMC and quality control processes, this biopharmaceutical expertise combines tailored kinetic assays (UV-Vis, fluorescence) with cutting-edge technologies (LC-MS, SEC, DSC) to assess activity across batches, characterize molecular structure, and profile critical impurities.
What is enzymology analysis?
Beyond structural characterization, enzymology analysis assesses the functional state of a biomolecule. It accurately measures an enzyme’s intrinsic ability to catalyze a biochemical reaction under strictly controlled physicochemical conditions (pH, temperature, cofactors).
The assay therefore goes beyond confirming the physical presence of the protein: it directly validates that the protein has the correct active three-dimensional conformation.
Why perform an enzyme activity assay?
Enzyme activity assays can be performed at various stages of the life cycle of a biotherapeutic product or development project:
- Quality control and batch release: verify compliance with biological activity specifications and ensure batch-to-batch consistency.
- Stability and formulation studies : measure the impact of time, excipients, packaging, or freeze/thaw cycles on the preservation of catalytic properties.
- Bioprocess optimization: ensure that scale-up, filtration, or purification (downstream processing) steps do not alter protein functionality.
- Regulatory compliance: provide the quantitative critical activity data required by health authorities (EMA, FDA) in accordance with applicable guidelines, particularly ICH Q6B.
- Deviation investigation (troubleshooting): identify the source of a loss of efficacy or reduced yield, or assess the direct impact of impurities and aggregates.
Our solutions for the analysis and characterization of your enzymes
Functional assessment (enzymology)
Real-time or endpoint quantification of substrate conversion (UV-Vis, fluorimetry).
Determination of constants (Km, Vmax) and monitoring of inhibition mechanisms
Customized protocols adapted to your matrix for quality control and stability testing.
Structural characterization and purity
Peptide mapping (peptide mapping) and accurate mass determination by LC-HRMS/MS.
Quantification of soluble monomers, dimers, and oligomers by SEC-Triple detection
Determination of folding and denaturation by DSC and FTIR.
Detection of post-translational modifications (PTMs), truncated forms, and trace metals (ICH Q3D).
Complementary biopharmaceutical expertise
Beyond enzymes, FILAB handles the characterization of all your biomolecules: recombinant proteins, peptides, glycosylation profiles, lipid formulations (LNPs), and advanced therapy medicinal products (CGT).
Our biopharmaceutical services
Why entrust your enzymology analysis to FILAB?
- Integrated approach : direct correlation between catalytic activity and structural integrity (SEC for aggregation, LC-MS for PTMs, DSC for thermal stability) on a 5,200 m² facility.
- Tailor-made development : specific and discriminating protocols designed to overcome matrix effects and the limitations of standard kits.
- Quality assurance : COFRAC ISO 17025-accredited laboratory (scope no. 1-1793 on www.cofrac.fr) ensuring data traceability and robustness.
- Dedicated technical support: a single scientific contact, responsive processing, and presentation of results during expert video debriefings
Go further
We also offer specific tests for process-related impurities, such as the quantification of elemental impurities in accordance with USP 233 and ICH Q3D, as well as extractables and leachables (E&L) analysis. Finally, we analyze cell culture media, including amino acids, vitamins, and saccharides, to ensure the quality of bioproduction processes.
FILAB is dedicated to providing tailored analytical solutions covering every stage of enzyme development and production, meeting your specific needs and ensuring high-quality results.
Our FAQ
Assaying an enzyme may target its quantity or presence using a given method. Measuring its activity assesses its functional capacity under the conditions selected for the assay. This information can be complementary, but it does not necessarily address the same question.
Enzymatic activity measurement provides an experimental value obtained using a defined substrate, temperature, pH, and protocol. Enzymatic activity control uses this measurement to address a quality-related question, such as verifying a specification, comparing a batch with a reference, or monitoring changes during storage. Interpretation requires comparable conditions, appropriate controls, and predefined criteria. An isolated result is therefore not sufficient to conclude that a product is globally compliant.
Both batches must be analyzed under comparable conditions: the same protocol, the same controls, the same reaction parameters, and consistent reporting of results. The relevance of the comparison also depends on sample representativeness and the production or storage context.
pH, temperature, reaction time, concentration, substrate selection, cofactors, matrix, and storage conditions may influence the measured response. These parameters must be controlled or documented in the analytical plan.
Yes, an investigation can compare a concerned sample with a reference and examine the conditions likely to influence activity. The strategy depends on the available history, the formulation, and the nature of the enzyme.
Adaptation is relevant when an existing method is not suitable for the matrix, the expected performance level, the enzyme under study, or the quality decision to be supported. The requirements should be defined with the filab laboratory before work begins.
An enzymology analysis is relevant for characterizing the catalytic activity of an enzyme, comparing batches, or investigating activity loss during storage. It complements structural and purity analysis by assessing substrate conversion under defined conditions.
The filab laboratory selects the protocol according to the enzyme in collaboration with its client, the matrix, and the project objective. For an enzyme intended for a biotherapeutic product, this study can help document functional quality attributes.
To request a quote for enzymatic analysis from FILAB, specify the nature of the enzyme, the matrix, the number of samples, and the objective of the study: enzymatic activity assay, batch comparison, stability, or investigation. Also indicate storage conditions, desired timelines, and any methods or quality requirements to be followed. This information enables the laboratory to define the analytical scope and prepare a quote suited to your needs.
The price of an enzyme analysis depends on the objective, the number of samples, the complexity of the matrix, and the required method.
An enzymatic activity assay using an existing method and a study requiring method development or validation do not require the same resources. Additional structural, purity, or stability analysis may also affect the cost. To find out the price suited to your project, request a personalized quote from FILAB, specifying the scope of the requested analysis.
