AAV Purity Analysis

Price and Turnaround

The AAV purity is a critical quality attribute that directly affects the efficacy, safety, and consistency of gene therapy products. During AAV production, a mixture of full, empty, and partially filled capsids is often generated, along with potential host cell proteins, DNA fragments, and other process-related impuritiesAccurate assessment of AAV purity is therefore essential to ensure optimal performance in both research applications and clinical manufacturing.

At AAVnerGene, we integrate these advanced analytical techniques to provide a comprehensive purity profile of AAV vectors — enabling accurate characterization, process optimization, and quality assurance throughout the AAV production workflow.

QCMethodTurnaroundPriceSample NumberSample Requirement
AAV PuritySDS-PAGE3-5 day$200/sample ~20μl of sample with titer >1E+12 vg/ml
AAV PurityMass Photometry1-2 day$800/sample120μl of sample with titer >5+11 vg/ml
$720/sample2~5
$640/sample6~10
$560/sample11~25
$480/sample25~50
$400/sample51~100
QuoteMore than 100

SDS-PAGE

SDS-PAGE is a gel electrophoresis technique that separates proteins based on their molecular weight. It involves denaturing proteins with SDS (a detergent) and heat, which gives them a uniform negative charge. The proteins are then separated in a polyacrylamide gel under an electric field, with smaller proteins migrating faster than larger ones.

SDS-PAGE is a powerful tool for assessing the purity of AAV preparations because it provides:

  • Separation of Capsid Proteins: SDS-PAGE separates the three capsid proteins (VP1, VP2, and VP3) based on their molecular weights:

    • VP1: ~87 kDa

    • VP2: ~72 kDa

    • VP3: ~62 kDa

  • Detection of Impurities: SDS-PAGE can identify contaminants, such as host cell proteins or degradation products, that may affect AAV quality.

  • Quantitative Analysis: The intensity of the protein bands can be quantified to determine the relative abundance of VP1, VP2, and VP3, ensuring the correct stoichiometry.

  • Regulatory Compliance: SDS-PAGE is a well-established method often required for regulatory submissions to demonstrate AAV purity.

Mass Photometry

Besides measuring full-to-empty ratios, mass photometry can also be used to analyze impurities in AAV preparations. Small protein contaminants or degradation products often appear as distinct peaks below 2000 kDa, which are clearly separated from the much larger empty AAV capsids (~3,700 kDa) and full capsids (~5,000 kDa, dependent on the size of AAV genome). This feature allows researchers to rapidly assess sample purity and detect residual host proteins, capsid fragments, or other impurities in real time — providing valuable insights into AAV quality during production and purification.

AAV Purity By Mass Photometry