mAb Aggregation testing: the challenge in biologics stability
Protein aggregation is the most common and concerning instability pathway for Monoclonal Antibodies (mAbs) and Recombinant Proteins.
FILAB supports biopharmaceutical companies by providing advanced aggregation profiling services. We help you detect, quantify, and characterize aggregates to secure your stability data and ensure patient safety.
Our Testing Services for Aggregation characterization testing
FILAB utilizes a multi-methodological strategy to ensure no aggregate goes undetected, complying with ICH Q6B guidelines.
Flow Imaging Microscopy (MFI / FlowCam)
DLS (Dynamic Light Scattering)
Why do your mAbs aggregate? (Root Cause Analysis)
mAbs aggregate
Thermal stress: Impact of temperature excursions
Mechanical stress: Shear forces during pumping, filling, or transport
Interface stress: Aggregation caused by air-liquid interfaces or silicone oil interaction.
Formulation: Screening of excipients (surfactants, sugars) to stabilize the monomer.
Why choose FILAB?
- State-of-the-Art Instrumentation: our 5200 m² facility hosts high-end UPLC-SEC, MALS detectors, and DLS systems.
- Regulatory compliance: services performed in an ISO 17025 accredited environment with GMP capabilities for batch release.
- Immunogenicity risk assessment: by characterizing the size and abundance of aggregates, we provide data essential for your clinical safety assessment.
- Fast track projects: agile project management to support urgent troubleshooting or clinical batch release.
Our FAQ
Yes. Using Flow Imaging Microscopy (dynamic imaging), we can analyze the morphology of sub-visible particles. Protein aggregates tend to be irregular, while silicone oil droplets (from syringes) are spherical. This distinction is critical for root cause analysis.
It varies by technique. DLS and SEC require very small volumes (typically <100 µL). Sub-visible particle analysis requires larger volumes (several mL) to ensure statistical significance. Contact us for a tailored feasibility assessment.
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.
