AAV Characterization Services

Adeno-associated virus (AAV) is a core delivery vector in gene therapy. Its non-pathogenic nature, long-term expression capability, and tissue-specific targeting make it an ideal tool for treating rare diseases, genetic disorders, and cancer. However, the safety and efficacy of AAV products highly depend on precise control of critical quality attributes (CQAs), including capsid integrity (empty/full ratio), genome titer, aggregation levels, and residual impurities (host proteins/DNA).

 



Wang, JH. et al. Signal Transduct Target Ther. 2024.

Figure 1. Current Clinical Applications of rAAV in Major Human Diseases

 

MtoZ Biolabs offers AAV Characterization Services, utilizing multi-dimensional analytical techniques to support gene therapy developers throughout the entire process development and clinical application cycle. Our services are designed to address industry challenges—providing rapid, accurate, and highly sensitive quantification of key AAV parameters to help clients optimize processes, reduce risks, and accelerate regulatory compliance.

 

MtoZ Biolabs offers AAV Characterization Services that:

1. Precisely analyze critical quality attributes: Covering key parameters such as empty/full capsid ratio, viral titer, particle aggregation, and purity assessment.

2. Adapt flexibly to different development stages: Supporting early-stage rapid screening to production-level quality control.

3. Ensure global regulatory compliance: Analytical methods align with international technical requirements for gene therapy.

4. Provide fully customized solutions: Tailored experimental designs with comprehensive data interpretation and process optimization recommendations.

 

Analysis Workflow

1. Sample Preparation & Pre-treatment

• Standardized sample reception and storage to maintain stability before analysis.
• Optional dilution and buffer exchange services as needed.

 

2. Multi-Technique Analytical Assessment

• Capsid Integrity: Uses SEC-MALS and mass photometry for high-resolution differentiation between empty, partially filled, and full capsids.
• Viral Titer & Genome Content: Utilizes high-efficiency qPCR/ddPCR for precise quantification of functional genome copies.
• Purity & Impurity Analysis: Detects host cell proteins (HCP), DNA residues, and process-related impurities using HPLC and ELISA.

 

3. Data Delivery & Interpretation

Comprehensive experimental reports delivered within ~15 business days, including detailed data visualization and statistical analysis.

 



Kontogiannis, T. et al. Mol Ther Methods Clin Dev. 2024.

Figure 2. The Workflow of AAV Characterization

 

Why Choose MtoZ Biolabs?

1. High Sensitivity & Resolution

Advanced instrumentation, including ultracentrifugation and high-resolution mass spectrometry, ensures detection limits as low as 1% for empty capsids, with full capsid resolution across complex samples.

 

2. Rapid Turnaround

Standard projects completed within 15 business days, with expedited options for urgent requests.

 

3. End-to-End Lifecycle Support

Continuous quality control strategies from vector candidate selection to commercial batch release.

 

4. Expert Cross-Disciplinary Team

Our technical team comprises experts in virology, analytical chemistry, and quality control, with experience supporting over 100 AAV projects.

 

Applications

• Process Development Optimization: Rapid screening of capsid integrity and aggregation issues in vaccine production to mitigate scale-up risks.
• Purification Process Validation: Evaluating chromatography resin performance using SEC-MALS to optimize elution gradients, achieving >90% empty capsid removal.
• Safety Assessment: Detecting host residual impurities to avoid immunogenicity-related clinical failures.

 

Case Study

1. Characterization of Adeno-Associated Virus Capsid Proteins Using Denaturing Size-Exclusion Chromatography Coupled with Mass Spectrometry

This study develops a denaturing size-exclusion chromatography coupled with mass spectrometry (dSEC-MS) method to characterize adeno-associated virus (AAV) capsid proteins (VPs). By optimizing SEC parameters, the method efficiently separates VP(1-3) monomers across various AAV serotypes (AAV1, 2, 5, 6, 8, and 9). The optimized dSEC-MS method enables the analysis of changes in AAV production processes and provides semi-quantitative detection of AAV DNA and VP components. This MS-friendly approach enhances the characterization of intact AAV VPs, aiding in quality control for AAV-based gene therapies.AAV Characterization Services offer comprehensive solutions for the analysis of adeno-associated virus (AAV) capsid proteins. By combining advanced chromatography and mass spectrometry techniques, we can effectively separate and characterize various VP components of AAV. This service helps users evaluate changes in AAV production processes, supporting quality control and development of AAV-based gene therapies to ensure product consistency and stability.

 



Tiambeng, TN. et al. J Pharm Biomed Anal. 2025.

Figure 3. dSEC-FLR-MS Analysis of AAV

 

2. Microfluidic AAV Purity Characterization

This study presents a rapid, high-throughput microfluidic electrophoresis technique for assessing full adeno-associated virus (AAV) capsids. It evaluates AAV1, AAV2, AAV6, AAV8, and AAV9 serotypes, with minimal modifications needed for AAV5. The method uses a mathematical formulation to combine capsid protein and single-stranded DNA (ssDNA) profiles, estimating the percentage of full capsids in a sample. With an average analysis time of less than 5 minutes per sample, it enables accurate characterization of AAV samples at concentrations of 2.5 × 10¹² VG/mL. AAV Characterization Services offer rapid and efficient solutions for analyzing AAV capsids. These services support the quality control of AAV-based gene therapies by quickly characterizing full capsids, providing accurate results with minimal sample volume and fast turnaround times, ensuring the consistency and reliability of AAV production processes.

 



Coll De Peña, A. et al. ACS Omega. 2024.

Figure 4. Electrophoretic Characterization of the Capsid Proteins of AAV1, 2, 6, 8, and 9

 

In today's increasingly competitive gene therapy landscape, controlling AAV product quality is fundamental to clinical success and commercialization. MtoZ Biolabs's AAV Characterization Services leverage cutting-edge analytical techniques and customized service solutions to help clients overcome process bottlenecks, accelerate development timelines, and ensure the safety and efficacy of every AAV vector. Whether you are exploring early-stage research or scaling up for large-scale production, our team is committed to providing technically robust, highly responsive, and comprehensive support. Contact our scientific team today and let us safeguard the success of your gene therapy products!