Regulatory-Ready AAV Gene Therapy Assay Services
AAV biodistribution testing, shedding analysis, AAV genome integrity sequencing, and immunogenicity assays are essential for regulatory approval of adeno-associated virus (AAV) gene therapies.
Accelevir offers GLP AAV testing CRO capabilities, pre-validated assay panels, and low-input workflows for vector copy number analysis in preclinical and clinical programs.
Challenges in AAV Gene Therapy Development
- Biodistribution mapping: Quantifying vector genomes in diverse tissues to meet FDA/EMA guidelines.
- Shedding analysis: Detecting vector release into body fluids to assess transmission risk.
- Genome integrity: Ensuring the therapeutic transgene remains intact and correctly packaged.
- Residual impurities: Measuring host cell or plasmid DNA carryover in final product.
- Immune responses: Monitoring adaptive and innate immunity to AAV capsids and transgene.
How Accelevir Supports AAV Programs
- Biodistribution Studies
- Multiplex dPCR/qPCR for vector genome copy number in multiple tissue types and species.
- GLP-compliant workflows aligned with FDA/EMA expectations.
- Vector Shedding Analysis
- Sensitive detection of AAV genomes in serum, urine, saliva, feces.
- Longitudinal sample tracking for shedding duration and magnitude.
- Genome Integrity Assessment
- Long-Read Sequencing to identify truncations, rearrangements, or partial genomes.
- Single-Viral-Genome Sequencing for variant discovery.
- Residual DNA Testing
- dPCR assays for plasmid DNA or host cell DNA contaminants.
- Validation against regulatory thresholds.
- Immunogenicity Monitoring
- ELISpot/ICS for capsid- and transgene-specific T cells.
- Multiparameter Flow Cytometry for immune subset phenotyping.
- Cytokine Multiplex for inflammatory biomarker profiling.
Why Partner with Accelevir
- Pre-validated AAV assay library shortens timelines.
- Integrated molecular + immune endpoints from a single lab.
- CLIA-certified, GLP-ready environment for clinical and preclinical studies.
- Experienced in low-volume and multi-species sample workflows.