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.
| 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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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.
