Unlock comprehensive insights into your AAV-based gene therapy products with our full suite of analytical services. Designed to support preclinical through clinical development, our assays ensure quality, identity, purity, and potency.

1. Viral Protein Characterization

• VP Identity & Post-Translational Modifications

  • Techniques: Intact Mass, Peptide Mapping via LC-MS/MS

  • Purpose: Confirms capsid protein identity and detects PTMs that may impact stability or efficacy.

• AAV VP Ratio Analysis

  • Techniques: Intact Mass, Capillary Gel Electrophoresis (CGE), CGE with Laser-Induced Fluorescence (CGE-LIF)

  • Purpose: Determines VP1:VP2:VP3 stoichiometry to assess capsid integrity.

2. Capsid Content Characterization

• Empty/Full Capsid Ratio

  • Techniques: Analytical Ultracentrifugation (AUC), Anion Exchange Chromatography (AEX), UV Spectroscopy (A260/A280), Hydrophobic Interaction Chromatography (HIC), Size Exclusion Chromatography with Multi-Angle Light Scattering (SEC-MALS)

  • Purpose: Quantifies empty vs. full capsids, critical for dosing accuracy and regulatory compliance.

3. Host Cell Protein (HCP) Analysis

• Techniques: ELISA, Mass Spectrometry

• Purpose: Detects and quantifies residual HCPs to mitigate immunogenicity risks.

4. Process-Related Impurity Quantitation

• Techniques: Customized LC-MS, HPLC, or ELISA workflows

• Purpose: Identifies and quantifies process-related contaminants (e.g., enzymes, reagents, media components).

5. Protein Visualization & Confirmation

• SDS-PAGE & Western Blot

  • Purpose: Visualize capsid protein profiles and confirm expression with target-specific antibodies.

6. Genomic Load & DNA Integrity

• DNA Gel Electrophoresis (Neutral & Alkaline)

  • Purpose: Assess integrity and conformation of packaged AAV genomes.

• DNA Size Distribution

  • Technique: Capillary Gel Electrophoresis (CGE)

  • Purpose: Evaluate genome length and homogeneity.

Customizable service packages available
Regulatory-compliant methods
Rapid turnaround times and expert interpretation