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.
| 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 |
(Scroll down to see more)
Restriction digestion analysis using multiple endonuclease to verify the plasmids to be used for AAV packaging.
Endotoxin Test by LAL assay
AAV Titering by qPCR (SYBR Green with standard curve for quantification)
AAV purity analysis by SDS-PAGE and Coomassie Staining (silver staining available upon request)
Note: ATCC VR-1816™ was used as the standards for AAV qPCR titering.
Legend: Lanes 2-5 and 7-1: AAV samples produced at PackGene. Lane 1,6: Marker）
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.
