AAV Testing Services

Key Benefits

Performance

• AAV Genome Titer by digital droplet PCR (ddPCR)

  Our advanced AAV analytical service employs ddPCR for high-precision viral genome quantification, supporting accurate dosing and lot consistency in gene therapy. Learn more about AAV genome titer by ddPCR

  

  Figure 1. AAV testing performance data: ddPCR scatter plot illustrates robust quantification of viral genome copies, delivering reliable titer measurements essential for regulatory compliance and therapeutic success.

• AAV Capsid Characterization by Mass Photometry (MP)

  Mass photometry is a breakthrough in AAV analytics, providing rapid, label-free quantification of full, empty, and partial capsids throughout purification. As part of PackGene’s advanced AAV analytical service, this technique delivers precise capsid composition data for process optimization, GMP quality control, and gene therapy success. Learn more about AAV Capsid Characterization by Mass Photometry.

  

  Figure 2. AAV analytical service progression: Multi-step histograms show mass photometry quantification of capsid population, providing detailed insight into process purity and vector quality across all manufacturing stages.

  Purification	Empty	Partial	Full	Total Particle	Full%
  Step 1	126	18	49	193	25.40%
  Step 2	518	98	410	1026	40.00%
  Step 3	665	169	1815	2649	68.50%
  Step 4	192	81	410	683	60.00%
  Drug Substance	292	74	715	1081	66.10%
  Drug Product	253	92	634	979	64.80%

• AAV Genome Sequencing by Nanopore

  Full-length AAV genome sequencing is vital to our AAV testing pipeline—ensuring integrity, mutation detection, and stable, therapeutic-grade vectors. Learn more about AAV genome sequencing by Nanopore

  

  Figure 3. AAV analytics sequencing panel: Depth coverage, ITR integrity, and mutation frequency maps confirm comprehensive vector evaluation using nanopore technology, part of PackGene’s leading AAV analytical services.

• Replication Competent AAV (rcAAV) Analysis by qPCR

  Safety and compliance drive PackGene’s AAV testing services—providing reliable results for regulatory and therapeutic needs. Sensitive qPCR detection assures freedom from rcAAV contamination in all GMP and GMP-like lots.

  

  Figure 4. AAV testing for safety: qPCR amplification curves differentiate between samples and controls, verifying absence of replication-competent AAV for therapeutic product release.

• Analysis by Analytical Ultracentrifugation (AUC) with Optional TEM Imaging

  Precise quantification of AAV full, empty, and aggregated capsids is achieved through our industry-leading AAV analytical service using analytical ultracentrifugation (AUC). AUC is recognized as the gold-standard method for analyzing capsid populations, ensuring consistent potency and optimal immunogenicity of gene therapy vectors. High-resolution AUC sedimentation profiles provide robust data for regulatory submissions, quality control, and batch release—core benefits of PackGene’s advanced AAV analytics. Learn more about AAV empty/full capsid ratio test by AUC

  

  Figure 5. AAV empty/full capsid rate analysis by Analytical Ultracentrifugation. AUC delivers high-resolution capsid quantification for advanced AAV testing and analytical service; TEM can be requested to visually characterize full, empty, and aggregate capsids for additional insight.

• AAV Genome Integrity by Capillary Electrophoresis (CE)

  CE-based AAV genome integrity testing enhances the rigor of our AAV analytics for vector quality and regulatory documentation. Learn more about AAV genome integrity by CE. Learn more about AAV genome integrity by CE

  

   Figure 6. Genome integrity performance: Capillary electrophoresis peak data validate packed genome size and purity, supporting downstream applications through comprehensive AAV testing.

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