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 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 and EMA/FDA guidelines.
Our comprehensive testing services for Biologics
Structural Characterization (ICH Q6B)
Primary Structure: Amino acid sequencing (De Novo), peptide mapping, 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.
Purity & Impurity Testing
Aggregates & Fragments: Analysis by SEC-MALS and AUC (Analytical Ultracentrifugation)
Host Cell Proteins (HCP): analysis by LC-MS/MS
Process Residuals: DNA, antibiotics, antifoams, and leachables from single-use systems
Physicochemical Properties
Molecular Weight: Intact mass analysis by High-Resolution Mass Spectrometry (Orbitrap/QTOF)
Charge Variants: Capillary Isoelectric Focusing (cIEF) and Ion Exchange Chromatography (IEX)
Extinction Coefficient: Determination for accurate concentration measurement
Potency & Binding Assays
Cell-Based Assays: Bioassays to measure biological activity (upon request/feasibility)
Why choose FILAB ?
- Integrated Expertise
- Regulatory compliance: all services are performed in an ISO 17025 accredited environment, with GMP context
- Method lifecycle management: from early feasibility and method development to full ICH Q2 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
We have extensive experience with Monoclonal Antibodies (mAbs), Bispecifics, Antibody-Drug Conjugates (ADCs), Fusion Proteins, Biosimilars, and Peptides.
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.
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.
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.
To get a quote, you can contact our team via our contact form, 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.
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.
