---
type: "WebPage"
title: "mAb Aggregation Characterization Testing Services"
description: "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..."
resource: "https://filab.fr/en/sectors-of-activity/biopharmaceutical/mab-aggregation-characterization-testing-services/"
tags: ["EN", "Anaïs DECAUX"]
timestamp: "2026-02-18T13:38:24Z"
published: "2026-02-18T13:38:20Z"
language: "en"
author: "Filab"
---

# mAb Aggregation Characterization Testing Services

## mAb Aggregation testing: the challenge in biologics stability

Protein aggregation is the most common and concerning instability pathway for [Monoclonal Antibodies (mAbs)](https://filab.fr/en/sectors-of-activity/biopharmaceutical/biotherapeutic-recombinant-protein-characterization/analysis-characterization-monoclonal-antibodies-mabs.md) and [Recombinant Proteins](https://filab.fr/en/sectors-of-activity/biopharmaceutical/biotherapeutic-recombinant-protein-characterization.md).

**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**](https://filab.fr/en/sectors-of-activity/biopharmaceutical/protein-characterization-ich-q6b-laboratory.md) guidelines.

SEC ([Size Exclusion Chromatography](https://filab.fr/en/our-technical-resources/laboratory-analysis-gpc-sec.md))

Flow Imaging Microscopy (MFI / FlowCam)

DLS ([Dynamic Light Scattering](https://filab.fr/en/our-technical-resources/dynamic-light-scattering-dls-analysis.md))

### Why do your mAbs aggregate? (Root Cause Analysis)

  services
## mAbs aggregate

 FILAB acts as a problem-solver during your formulation development or stress testing studies. We investigate:
**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

 Can you distinguish between protein aggregates and silicone oil droplets?
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.

 How much sample volume is needed for an aggregation study?
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.

 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.