- Separation based on hydrodynamic radius to detect monomer, dimer, oligomers, and high-molecular-weight aggregates.
- Quantitative analysis of relative population percentages.
- Compatibility with formulation buffer analysis for real-world sample assessment.
Antibody Aggregation & Size Distribution Analysis Service
Introduction
Antibody aggregation and size heterogeneity are critical quality attributes that directly impact solubility, stability, immunogenicity, and therapeutic performance. Aggregates can form during expression, purification, concentration, storage, or formulation, and even low levels may cause loss of activity, altered pharmacokinetics, or increased risk of immune responses in vivo. Precise characterization of both aggregation state and size distribution is essential for quality assessment, process optimization, and formulation development.
Our Antibody Aggregation & Size Distribution Analysis Service offers comprehensive, multi-platform evaluation to detect, quantify, and characterize aggregated species as well as monomeric antibodies. By combining Size-Exclusion Chromatography (SEC-HPLC), Dynamic Light Scattering (DLS), Mass Photometry (MP), Analytical Ultracentrifugation (AUC), and Orthogonal Biophysical Techniques, we provide detailed insight into the aggregation profile and size distribution of antibodies.
Strategies
Size-Exclusion Chromatography (SEC-HPLC)
Dynamic Light Scattering (DLS)
- Rapid detection of particle size distribution in solution.
- Identification of small aggregates or early-stage oligomerization not easily detected by SEC.
- Provides hydrodynamic radius and polydispersity index to assess homogeneity.
Mass Photometry (MP)
- High-resolution single-molecule mass analysis under native conditions.
- Detects monomer vs oligomer populations at very low concentrations without labeling.
- Complementary to SEC and DLS for early aggregation detection.
Analytical Ultracentrifugation (AUC)
- Sedimentation velocity analysis for size, shape, and molecular weight distribution.
- Resolves overlapping species that may co-elute in SEC.
- Ideal for verifying oligomeric states and quantifying low-level aggregates.
Orthogonal Data Integration
- Combining results from multiple platforms ensures accurate identification and quantification of aggregates.
- Correlation with functional assays (e.g., BLI or ELISA) determines whether aggregation affects antigen binding.
- Enables rational optimization of formulation, storage, and handling conditions to minimize aggregation.
Required Materials
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Antibody Samples
- Concentration: 1–5 mg/mL; minimum volume: 200–500 µL per assay.
- Samples can be in formulated buffers or purified preparation.
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Buffer Information
- Full composition, pH, excipients, and any stabilizers to interpret aggregation trends.
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Project Notes
- Known stress conditions, storage history, or prior aggregation issues.
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Optional Reference Materials
- Well-characterized antibody batch for comparison or calibration.
Proper cold shipment and labeling are required to preserve sample integrity.
Publications
Aggregation and size distribution assessment is widely referenced in antibody characterization literature:
These references support the use of SEC, DLS, MP, and AUC as complementary methods for comprehensive aggregation profiling.
FAQs
How sensitive are the aggregation detection methods?
SEC-HPLC detects aggregates ≥0.5%, DLS can identify particles in the nanometer range, MP resolves single-molecule oligomers, and AUC provides quantitative distribution even at low concentrations.
Can these methods detect reversible vs irreversible aggregates?
DLS and MP detect reversible, weakly associated oligomers, while SEC and AUC can distinguish stable, irreversible aggregates.
Do aggregates affect antigen binding?
Aggregates can reduce functional binding; optional BLI or ELISA analysis can be integrated to correlate aggregation with binding activity.
How long does a complete aggregation analysis take?
10–15 business days depending on sample number, complexity, and whether functional correlation is included.
Can formulated antibodies be directly analyzed?
Yes. We can assess antibodies in their formulation buffer, with minor buffer exchange if excipients interfere with measurement.
Contact Us
Our Antibody Aggregation & Size Distribution Analysis Service provides a detailed and reliable profile of antibody monomeric and aggregated species, enabling informed decisions in formulation, purification, and process development.
For consultation, project planning, and sample submission, contact our team. Provide antibody details, buffer composition, and any prior aggregation observations for a tailored, high-resolution assessment.
For research use only. Not intended for any clinical use.
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