AAV Analytical Services

Comprehensive AAV Solutions, From Discovery to Delivery
Overview
PackGene has established multiple advanced AAV analytical testing platforms. Beyond our standard AAV quality control tests, such as toxicity, genomic titer, and purity, we also offer an extensive list of specialized assays, including titration, genome integrity, characterization, purity, aggregation, contamination, and safety.

These assessments collectively offer a comprehensive evaluation of the AAV vectors, ensuring that your AAVs meet even the most stringent standards for safe and effective gene therapy applications.

Highlights
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Extensive Capabilities

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Safety Assurance

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Timely Results

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Expert Guidance

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Uncompromising Quality

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Tailored Solutions

Services Details

We offer more than 40 standarized AAV quality assays.

Category SKU# Test Method Turnaround Time
(Calendar Day)
Titration AAVQC001-001 AAV Genome Titration <ddPCR> ddPCR 5
AAVQC001-002 Custom ddPCR probe and primer synthesis 5-7
AAVQC001-003 AAV Capsid Titration ELISA 5
AAVQC001-004 Infectious Titer <TCID50> Serial Dilution and qPCR 21
Genome Integrity AAVQC002-001 AAV Genomic Integrity <CE> CE 5
AAVQC002-002 AAV Genomic Sequencing <TGS> 3rd Generation Sequencing 5-10
AAVQC002-003 AAV Identity by Sanger sequencing Sanger sequencing 3-5
AAVQC002-004 Alkaline Gel Electrophoresis Agarose gels 6
Capsid characterization, purity and aggregation AAVQC003-001 AAV Empty Capsid Rate <AUC> AUC to analyze empty capsid rate 5
AAVQC003-002 TEM (5 pictures) +report TEM 3-5
AAVQC003-003 DLS (Dynamic light scattering) Dynamic light scattering 5
AAVQC003-004 AAV Capsid Peptide Mapping HPLC-MS/MS 21
AAVQC003-005 Capsid Protein Molecular Weight and Ratio RP-HPLC-MS 21
AAVQC003-006 Capsid purity Analysis <SDS-PAGE> SDS-PAGE with Silver Staining 2-3
AAVQC003-007 Capsid purity Analysis <SDS-PAGE> SDS-PAGE with Coomassie Blue Staining 5
AAVQC003-008 Capsid purity Analysis <CE-SDS> CE-SDS 5
AAVQC003-009 Purity Analysis <AEC-HPLC> AEC-HPLC 5
AAVQC003-010 Purity and Aggregation Analysis <SEC-HPLC> SEC-HPLC 5
Contamination AAVQC004-001 Residual Host HEK293 Cell DNA Quantification qPCR 5
AAVQC004-002 Residual HEK293 Host Cell DNA Sizing qPCR 5
AAVQC004-003 Residual Plasmid DNA ddPCR 5
AAVQC004-004 Residual E1A ddPCR 5
AAVQC004-005 Residual Host Cell Protein ELISA 5
AAVQC004-006 Residual BSA ELISA 5
AAVQC004-007 Residual Nuclease ELISA 5
AAVQC004-008 Residual Affinity Ligands ELISA 5
AAVQC004-009 Residual PEI HPLC 5
AAVQC004-010 Residual Tween20 HPLC 5
AAVQC004-011 Residual Triton X100 HPLC 5
AAVQC004-012 Residual Iodixanol HPLC 5
AAVQC004-013 Residual Poloxamer 188 HPLC 5
AAVQC004-015 Residual Triton Analysis(bundle with endo removal) HPLC 5
Safety AAVQC005-001 Endotoxin removal Triton 2-3
AAVQC005-002 Sterility test Innoculation 14-20
AAVQC005-003 Mycoplasma detection Gel 2-3
AAVQC005-004 Endotoxin test LAL 3
AAVQC005-005 Quantitative Endotoxin test Kinetic Chromogenic Assays 3
AAVQC005-006 Bioburden Test Plate count method 5
AAVQC005-007 Mycoplasma detection by qPCR qPCR 2-3
AAVQC005-008 Replication Competent AAV (rcAAV) Analysis Infection on Permissive Cells 21

(Scroll down to see more)

Performance

AAV Genome Titer by ddPCR

Provides precise quantification of viral genome copies, ensuring accurate assessment of viral load. This is essential for determining effective dosages and maintaining batch-to-batch consistency in gene therapy applications.

AAV genome titer by ddPCR

AAV Genome Integrity by CE

Evaluates the structural integrity of AAV genomes by identifying fragmentation or degradation. These measures are key determinants of AAV stability, efficacy, and safety.

AAV genome integrity analysis by CE

AAV Genome Sequencing by Nanopore

Offers detailed analysis of the AAV genome by detecting mutations, insertions, and deletions. This comprehensive genome evaluation ensures the fidelity and stability of the AAV vector and is essential for therapeutic use.

Nanopore sequencing reads depth from 5‘ ITR to 3’ ITR

AAV Empty Capsid Rate Test by AUC

Measures the proportion of empty versus full capsids, which is critical for determining the potency and immunogenicity of a therapy. AUC is the gold-standard method for measuring empty capsid rate and helps to ensure the delivery of high-quality viral vectors.

AAV empty capsid rate analysis by AUC

Replication Competent AAV (rcAAV) Analysis

Detects and quantifies replication-competent AAV, which is essential for ensuring the safety of gene therapies. Minimizing rcAAV contamination is necessary to prevent unwanted viral replication in patients.

Resources
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Overview of Key AAV Analytical Testing for Gene Therapy Development

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