Adeno-Associated Virus (AAV) Testing

Adeno-Associated Virus (AAV) vectors play a crucial role in gene therapy due to their efficient gene delivery, versatility, long-term expression, low immunogenicity, and safety. Avance Biosciences supports AAV manufacturers by performing essential characterization assays for identity, purity, potency, and more.

Critical Quality Attributes

Assay

Description

Identity

Capsid Identity

Confirm the identity of the AAV capsid serotype using ELISA or Jess or CE-SDS

Sequence Confirmation

Verify the sequence of AAV genome by Sanger Sequencing or NGS

Identity

Capsid Identity

Confirm the identity of the AAV capsid serotype using ELISA or Jess or CE-SDS

Long Read NGS

Sequence AAV genome by long read Nanopore sequencing

Purity

Residual Plasmid DNA

Quantify residual host cell DNA using qPCR or ddPCR.

Capsid content (empty/full ratio)

Measure the percent of full to empty capsids by CE-SDS

Capsid purity Analysis

Assess the purity of AAV capsid proteins using CE-SDS or Jess

Purity

Residual Plasmid DNA

Quantify residual plasmid DNA using qPCR or ddPCR.

Residual host cell DNA

Quantify residual host cell DNA using qPCR or ddPCR.

Residual Host Cell Protein

Determine presence and quantitate residual host cell proteins by ELISA

Potency

Vector Genome Titer

Quantify the number of vector genomes using qPCR or ddPCR.

Cell-based assay

Develop cell-based assay for evaluating post-transduction endpoint (mRNA expression, protein production)

Genetic Integrity

Vector Genome Integrity

Confirm the integrity of the vector genome using QPCR/ddPCR or Bioanalyzer or CE

Safety

Bioburden

USP <61>

Endotoxin

USP <85>

Safety

Bioburden

USP <61>

Sterility

USP <71>

Other

USP <790>

Osmolality

USP <791>

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