AAV Analytical QC Services
As a leading gene therapy AAV CDMO, we maintain a robust and reliable quality control system in both process development and production.
PackGene has a highly skilled and experienced team that is dedicated to developing and delivering methods for QC tests of plasmid and AAV production. Currently, we have developed a comprehensive range of AAV-based QC methods to ensure the critical quality attribute (CQA), such as identity, purity, content/potency and safety, consistent at every stage of manufacturer under GMP conditions.
We provide the entire QC service covers from raw materials to the final product of AAV, which could meet the stringent QC requirements of your precious projects.
| AAV | Assay | Methods |
| Identity | GOI DNA Sequence | Sanger Sequence |
| AAV Capsid | SDS PAGE/MS | |
| Purity | HPLC Purity | HPLC |
| UV Purity | Spectrophotometry | |
| %Empty capsids | AEX HPLC | |
| TEM | ||
| AUC | ||
| Potency & Content | Vector Capsid Titer | ELISA |
| Vector Genome Titer | ddPCR | |
| Infectivity | TCID50 | |
| BioAssay trans-protein antigen | In vitro transduction | |
| Impurity | Residual Host Cell DNA | qPCR |
| Residual E1A | qPCR | |
| Residual Host Cell Protein | ELISA | |
| Residual BSA | ELISA | |
| Residual Plasmid | ddPCR | |
| Residual Nuclease | ELISA | |
| Residual Iodixanol | HPLC | |
| Residual Ligand | ELISA | |
| Safety | Mycoplasma | 21CFR |
| rcAAV | Cell Assay+qPCR | |
| Bacterial endotoxin | LAL | |
| Sterility | USP 21CFR | |
| Adventitious agent | Cell Culture | |
| Abnormal toxicity | Animal test | |
| General Characterizaiton | Appearance | Visual Inspection |
| pH | Potentiometry | |
| Osmolarity | Osmometry | |
| Particulate matter | Light Obscuration Particle Count test | |
| Aggregation | DLS |
PackGene provides the implementation of new assays that follows through several stages: development, optimization, qualification, and validation.
- Assay development. Confirming the CQA accordingto QbD, and the necessary instrumentation and reagents (and/or kits). Outlining the performance parameters on a preliminary basis.
- Assay optimization. During this phase, a series of experiments are conducted and the methodparameters are confirmed for different sample conditions. Those information will be used to set the acceptance criteria for rapid service.
- Assay Validation. The protocol is reviewed under the same procedure as in the qualification phasebut in a more comprehensive manner. Assay performance is documented with respect to accuracy, linearity, range, the limit of detection (LOD), the limit of quantitation (LOQ), specificity/selectivity, precision, and suitability. Validation may include inter-laboratory comparisons as well.
Development of assays are typically re-evaluated to an established schedule to confirm that they continue to perform as originally intended. Methods are also reassessed as existing technologies developed, regulatory supervision are updated or any other factors arise that may necessitate a method change in methodology. To get a quote or technical advice from PackGene, please provide specific project details.
