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AAV Analytical Services

PackGene has established multiple advanced AAV analytical testing platforms. We have done extensive quality investigations for our AAV packaging services including raw materials, harvest fluid, stock solution, to final products. In addition to our standard quality control tests, we also offer an extensive list of advanced resting procedures including test for toxicity, genomic titer (by qPCR or ddPCR), endotoxin or mycoplasma, 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 process that meets your needs.

Interested in our AAV services? Please contact us for a free consultation or  submit a request for a quotation.
PackGene AAV Analytical Services
Cat No. Test Method Sample Requirement Turnaround Time
(Calendar Day)
DT001 AAV Genome Titration <ddPCR> ddPCR Custome primers/probe sequence and predicted titer range; Sample volume>10μl 7
DT002 AAV Capsid Titration ELISA Information of AAV serotype and sample matrix solution 2ml (with buffer info and pH); Sample volume>10μl 7
DT003 Infectious Titer <TCID50> Serial Dilution and qPCR Genome titer or predicted titer range; Sample volume>10μl 21
DT004 Purity Analysis <SDS-PAGE> SDS-PAGE with Coomassie blue staining Sample titer>1E+12vg/ml; Sample volume>10μl 7
DT005 Purity Analysis <CE-SDS> CE-SDS Sample titer> 1E+12vg/ml; Sample volume>30μl 7
DT006 Purity Analysis <AEC-HPLC> AEC-HPLC Sample titer> 1E+12vg/ml; Sample volume>50μl 7
DT007 Purity and Aggregation Analysis <SEC-HPLC> SEC-HPLC Sample titer> 1E+12vg/ml; Sample volume>50μl 7
DT008 AAV Capsid Peptide Mapping HPLC-MS/MS Genome titer>5E+12vg/ml; Sample volume>500μl 21
DT009 Capsid Protein Molecular Weight and Ratio Analysis RP-HPLC-MS Genome titer> 5E+12vg/ml; Sample volume>100μl 21
DT010 Residual Host Hek293 Cell DNA qPCR Genome titer 7
DT011 Residual Hek293 Host Cell DNA qPCR Genome titer 7
DT012 Residual plasmid DNA ddPCR Genome titer 7
DT013 Residual E1A ddPCR Genome titer 7
DT014 Residual Host Cell Protein ELISA Sample matrix solution 2ml (with buffer info and pH) 7
DT015 Residual BSA ELISA Sample matrix solution 2ml (with buffer info and pH) 7
DT016 Residual Nuclease ELISA Sample matrix solution 2ml (with buffer info and pH) 7
DT017 Residual Affinity Ligands ELISA Sample matrix solution 2ml (with buffer info and pH) 7
DT018 Residual PEI HPLC Sample matrix solution 2ml; Sample volume>200μl 7
DT019 Residual Tween20 HPLC Sample matrix solution 2ml; Sample volume>100μl 7
DT020 Residual Triton X100 HPLC Sample matrix solution 2ml; Sample volume>100μl 7
DT021 Residual Iodixanol HPLC Sample matrix solution 2ml; Sample volume>100μl 7
DT022 Residual Poloxamer 188 HPLC Sample matrix solution 2ml; Sample volume>100μl 7
DT023 Replication-Competent AAV (rcAAV) Analysis Infection on Permissive Cells Titer>1E+12vg/ml; Volume>50μl 30
DT024 AAV Genomic Integrity <CE> CE-SDS Titer>1E+12vg/ml; Volume>50μl 7
DT025 AAV Genomic Sequencing <TGS> 3rd Generation Sequencing >5E+12vg 40
DV001 Analytical Method Development and Validation Genome titration <ddPCR> Predicted titer range and primer sequences 30
DV002 Analytical Method Development and Validation TCID50 Determined genome titer or predicted genome titer range 50
DV003 Analytical Method Development and Validation rcAAV Analysis N/A 50
DV004 Analytical Method Development and Validation Capsid Analysis (AUC) 10ml per sample 50
DV005 Analytical Method Development and Validation Capsid Analysis (AEC HPLC) 5ml per sample 30
DV006 Analytical Method Development and Validation AAV Gene Expression Level Per Project Plan Starting from 30
DV007 Analytical Method Development and Validation AAV Potency Per Project Plan Please Inquire
TS001 Analytical Method Development, Validation, and Release Testing Service (full suite) Per Project Plan Per Project Plan 60
TS002 AAV Release Testing Service Per Project Plan Per Project Plan Please Inquire
TS003 AAV Stability Testing Service Per Project Plan Per Project Plan Please Inquire

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1. Standard QC

① Restriction digestion analysis using multiple endonuclease to verify the plasmids to be used for AAV packaging.
② AAV Titering by qPCR (SYBR Green with standard curve for quantification)

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

③ AAVpurity analysis by SDS-PAGE and Coomassie Staining (silver staining available upon request)

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

④ Endotoxin Test by LAL assay

2. Other available analytical tests

① HPLC purity analysis

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

② TEM

*If you have custom assay requests, please fill out quote form. The lead time above is counted when the samples’ arrival. The assay report will be sent out by E-mail.