--- type: "WebPage" title: "Large Molecules Analysis & Characterization Testing Services" description: "Large Molecule Analysis The landscape of modern medicine is increasingly dominated by large molecules (Biologics). Unlike small molecules synthesized chemically, biologics such as Monoclonal Antibodies (mAbs), Recombinant Proteins, ADCs, and Gene Therapies are produced in living systems. This inherent complexity..." resource: "https://filab.fr/en/sectors-of-activity/biopharmaceutical/large-molecules-analysis-characterization-testing-services/" tags: ["EN", "Anaïs DECAUX"] timestamp: "2026-02-25T13:21:21Z" published: "2026-02-18T13:05:19Z" language: "en" author: "Filab" --- # Large Molecules Analysis & Characterization Testing Services ## Large Molecule Analysis The landscape of modern medicine is increasingly dominated by large molecules (Biologics). Unlike small molecules synthesized chemically, biologics such as [Monoclonal Antibodies (mAbs)](https://filab.fr/en/sectors-of-activity/biopharmaceutical/biotherapeutic-recombinant-protein-characterization/analysis-characterization-monoclonal-antibodies-mabs.md), [Recombinant Proteins](https://filab.fr/en/sectors-of-activity/biopharmaceutical/biotherapeutic-recombinant-protein-characterization.md), [ADCs](https://filab.fr/en/sectors-of-activity/biopharmaceutical/adc-sequencing-services-laboratory-antibody-drug-conjugate.md), and Gene Therapies are produced in living systems. This inherent complexity leads to heterogeneity and stability challenges that require sophisticated analytical strategies. **FILAB** supports biopharmaceutical companies throughout the drug development lifecycle. We provide comprehensive analytical testing services to characterize the structure, purity, potency, and safety of your large molecule candidates, ensuring compliance with [ICH Q6B](https://filab.fr/en/sectors-of-activity/biopharmaceutical/protein-characterization-ich-q6b-laboratory.md) and EMA/FDA guidelines. ### Our comprehensive testing services for Biologics services ## Structural Characterization (ICH Q6B) Understanding the molecule’s "fingerprint" is the first step in proving identity and comparability. Primary Structure: Amino acid sequencing ([De Novo](https://filab.fr/en/sectors-of-activity/biopharmaceutical/biotherapeutic-recombinant-protein-characterization/de-novo-protein-sequencing.md)), [peptide mapping](https://filab.fr/en/sectors-of-activity/biopharmaceutical/biotherapeutic-recombinant-protein-characterization/peptide-analysis-biopharmaceutical-services.md), and N/C-terminal sequencing. Higher-Order Structure (HOS): Assessment of secondary and tertiary structures via CD, FTIR, and disulfide bridge analysis Post-Translational Modifications (PTMs): Detailed analysis of glycosylation (N-glycans), oxidation, and deamidation. services ## Purity & Impurity Testing Safety is paramount. We detect and quantify both product-related and process-related impurities Aggregates & Fragments: Analysis by [SEC-MALS](https://filab.fr/en/our-technical-resources/laboratory-analysis-gpc-sec.md) and AUC (Analytical Ultracentrifugation) [Host Cell Proteins (HCP)](https://filab.fr/en/sectors-of-activity/biopharmaceutical/host-cell-protein-hcp-testing-analysis-laboratory.md): analysis by [LC-MS/MS](https://filab.fr/en/our-technical-resources/laboratory-analysis-uplc/laboratory-analysis-hplc-lcms.md) Process Residuals: DNA, antibiotics, antifoams, and [leachables](https://filab.fr/en/our-services/our-expertise-services/laboratory-extractable-leachable-testing.md) from single-use systems services ## Physicochemical Properties Defining the physical behavior of your drug substance Molecular Weight: Intact mass analysis by [High-Resolution Mass Spectrometry](https://filab.fr/en/our-technical-resources/high-resolution-mass-spectrometry-hrms-analysis.md) (Orbitrap/QTOF) Charge Variants: Capillary Isoelectric Focusing (cIEF) and Ion Exchange Chromatography (IEX) Extinction Coefficient: Determination for accurate concentration measurement services ## Potency & Binding Assays Confirming that the molecule works as intended Cell-Based Assays: Bioassays to measure biological activity (upon request/feasibility) ## Our technical resources Our 5200 m² laboratory is equipped with state-of-the-art instrumentation dedicated to large molecule analysis: [### LC-MS/MS (Q-TOF, Orbitrap) sequencing and identification](https://filab.fr/en/our-technical-resources/altis-lc-msms-analysis.md) [### UPLC, HPLC (SEC, IEX, RP, HIC) purity and separation](https://filab.fr/en/our-technical-resources/high-pressure-liquid-chromatography-uplc-laboratory.md) [### CD, FTIR, UV-Vis structural integrity](https://filab.fr/en/our-technical-resources/laboratory-analysis-ftir-spectroscopy.md) Discover our case study ## ADC Analysis: key questions & answers [Learn more](https://filab.fr/en/adc-analysis-services-expert-qa-filab-laboratory.md) ### Why choose FILAB ? - Integrated Expertise - **Regulatory compliance**: all services are performed in an [ISO 17025](https://filab.fr/en/about-us/accreditations-en/laboratory-analysis-iso-17025.md) accredited environment, with GMP context - **Method lifecycle management**: from early feasibility and method development to full [ICH Q2](https://filab.fr/en/our-services/our-expertise-services/life-cycle-of-an-analytical-method-in-the-laboratory/laboratory-analytical-method-validation/validation-of-laboratory-analysis-methods-according-to-the-ich-q2-standard/) validation and transfer. - **Agility & Consulting**: direct access to PhD-level experts who help you design the right study for your specific phase (Pre-clinical, Phase I-III). ## Our FAQ What types of large molecules do you handle? We have extensive experience with Monoclonal Antibodies (mAbs), Bispecifics, Antibody-Drug Conjugates (ADCs), Fusion Proteins, Biosimilars, and Peptides. Can you support Biosimilarity studies? Yes. We perform head-to-head comparability studies (Biosimilar vs. Reference Product) to demonstrate high similarity in physicochemical and structural attributes, a key requirement for regulatory approval. Do you offer GMP batch release testing? Absolutely. We can act as your external QC laboratory for GMP release testing of Drug Substance (DS) and Drug Product (DP), including identity, purity, and safety tests. How do you handle method transfer? We follow a structured transfer protocol (checking robustness, precision, and accuracy) to ensure your existing methods perform correctly in our facility, minimizing downtime in your project.   How to get a quote with FILAB? To get a quote, you can contact our team via our [contact form](https://filab.fr/en/contact-form.md), by phone, or by email. Simply send us your requirements (material type, desired analysis, specific standards, urgency, number of samples, etc.). We will then send you a personalized technical and price proposal within **24 to 48 hours**. What is the typical turnaround time for analysis? Turnaround times vary depending on the nature of the analysis and the complexity of the project. However, FILAB is committed to providing fast results tailored to your industrial constraints and urgent needs.