AAV Analytical Services

Overview

PackGene has established multiple advanced AAV analytical testing platforms. We have done extensive quality investigations for our AAV packaging services which includes testing of raw materials, harvest fluid, stock solution, and final products. In addition to our standard quality control tests, we also offer an extensive list of advanced testing procedures including test for toxicity, genomic titer (by qPCR or ddPCR), endotoxin or mycoplasma levels, empty shell rate via TEM, and more. We understand that each experiment comes with its own set of quality requirements, and our virologists and QC engineers promise to deliver a robust analytical testing protocol that meets your needs.

Services Details
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 Oligo 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
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 SddPCR 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
AAVQC004-014 Replication Competent AAV (rcAAV) Analysis Infection on Permissive Cells 21
AAVQC004-015 Residual Triton Analysis(bundle with endo removal) HPLC 5
Safety AAVQC005-001 Endotoxin removal 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

 

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Standard QC
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Restriction digestion analysis using multiple endonuclease to verify the plasmids to be used for AAV packaging.

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Endotoxin Test by LAL assay

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AAV Titering by qPCR (SYBR Green with standard curve for quantification)

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AAV purity analysis by SDS-PAGE and Coomassie Staining (silver staining available upon request)

AAV Titering by qPCR

Note: ATCC VR-1816™ was used as the standards for AAV qPCR titering.

AAV purity analysis

Legend: Lanes 2-5 and 7-1: AAV samples produced at PackGene. Lane 1,6: Marker)

Other Available Analytical Tests

HPLC purity analysis

HPLC purity analysis

AAV2-EGFP Sample produced at PackGene. The purity as analyzed by HPLC was 99%.

TEM

*If you have custom assay requests, please fill out our quote form. The lead time above is counted form the time that the samples’ arrive at our facility. Assay reports will be sent by E-mail.

Contact Us

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