You wish to perform the characterization of your AAVs by GPC according to the MAM method
The Multi-Attribute Method (MAM) is an advanced analytical approach used by the biopharmaceutical industry to characterize several critical quality attributes (CQAs) of a biopharmaceutical or viral vector (such as AAVs) in a single analysis. It is consistent with ICH Q6B guidelines.
An advanced approach to controlling critical quality attributes (CQA) and process attributes (PQA)
Adeno-associated viral vectors (AAVs) are now central to the development of gene therapies. Their quality, structural integrity, and homogeneity directly influence therapeutic efficacy and patient safety.
To ensure this control, the precise characterization of Critical Quality Attributes (CQAs) and Process Quality Attributes (PQAs) is essential at each stage of development.
Our MAM services for the characterization of AAVs
Determination of molar mass and distribution of viral particles
Evaluation of the proportion of full vs. empty capsids
Development and validation of specific methods, according to your industrial needs
Detection and quantification of aggregates and abnormal shapes
Monitoring of physico-chemical stability and structural changes during the process
Our GPC/SEC analysis techniques
To support biopharmaceutical manufacturers in the characterization of AAVs by GPC/SEC according to the MAM method, the FILAB laboratory has 2 multi-detection GPC/SECs: UV / RI / Viscometer / LALS-RALS.
The FILAB laboratory assists you in the characterization of your AAVs by GPC according to the MAM method
The MAM method by SEC/GPC: a complete view of your AAVs
The multi-attribute method (MAM) is based on size-exclusion chromatography (SEC/GPC), a powerful analytical approach that allows for the simultaneous evaluation of several key characteristics of viral vectors:
- Molar mass and distribution: precise measurement of capsid size, polydispersity, and molecular profile.
- Conformation and aggregation: detection of aggregated, malformed, or denatured particles that can compromise product stability.
- Filled vs. empty capsids: quantification of functional/non-functional particles, a crucial indicator for the efficacy of gene therapies.
- Integrity and structural stability: monitoring of the physicochemical state of AAVs throughout development, production, and storage.
Thanks to this multi-detector approach, SEC/GPC-based MAM provides a comprehensive understanding of AAV quality and performance in a single test.
Why entrust your MAM analyses to our laboratory?
Our teams are proficient in multi-detector SEC/GPC techniques, combining UV, light scattering and refractometry, for a fine and reliable characterization of viral particles.
The protocols developed are based on ICH Q6B, EMA and FDA recommendations, guaranteeing the robustness and reproducibility of the results.
Our experts support you in the interpretation of analytical data, the monitoring of CQA and PQA, as well as in the documentation required for your preclinical and clinical studies.
We are involved throughout the entire product lifecycle:
- process development and optimization,
- identification of critical parameters,
- monitoring of quality and stability across batches.
The analyses are performed in-house at our COFRAC ISO 17025 accredited laboratory, ensuring controlled turnaround times, detailed reporting, and the option of video debriefings with our experts. This process adheres to ICH Q6B guidelines.
Our other biopharmaceutical analysis services
Analysis according to ICH 6B guideline
FAQ
The multi-attribute method (MAM) is an analytical approach that allows for the characterization of several key properties of a viral vector in a single analysis.
Coupled with size-exclusion chromatography (SEC/GPC), it provides a comprehensive view of the Critical Quality Attributes (CQA) and Process Quality Attributes (PQA) of AAVs: molar mass, homogeneity, aggregates, filled/empty capsids, stability, etc.
Size Exclusion Chromatography (or Gel Permeation Chromatography) separates particles according to their size and molecular mass.
In MAM, it is coupled with several detectors (UV, light scattering, refractometry, etc.) to simultaneously measure several structural and functional attributes of AAVs.
Unlike traditional approaches that require several separate analyses, MAM allows:
- obtaining multiple results in a single measurement,
- improving data reproducibility and comparability,
- ensuring precise quality monitoring throughout development and production.
It plays a role at every stage:
- Preclinical development: understanding vector behavior.
- Industrialization: process control and monitoring of quality assurance programs.
- Production: verifying batch consistency.
- Stability: evaluating product evolution over time.
MAM thus helps to secure the process and anticipate quality deviations.
Yes. Multi-attribute methods are aligned with ICH Q6B guidelines and are recognized by regulatory agencies (EMA, FDA) for the characterization of biological products and viral vectors.
They support regulatory documentation by providing robust and traceable data.
