As a leading AAV CDMO for gene and cell therapy applications, PackGene maintains a robust and reliable quality control system across both process development and production stages.
PackGene has a highly skilled and experienced team that is dedicated to developing and delivering leading edge methods for QC analysis of plasmid and AAV samples. Currently, we have developed a comprehensive range of AAV-based QC methods to ensure critical quality attributes (CQA) including identity, purity, content, potency, and safety at every stage of the GMP manufacturing process.
PackGene’s GMP-grade QC service covers raw materials through final AAV products to meet even the most stringent QC requirements.
| 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 Characterization | Appearance | Visual Inspection |
| pH | Potentiometry | |
| Osmolarity | Osmometry | |
| Particulate matter | Light Obscuration Particle Count test | |
| Aggregation | DLS |
PackGene provides services for development, optimization, validation, and implementation of quality control assays designed for your specific projects. Assay services include:
Assay development
Assays are designed to confirm CQA according to QbD principles. In this phase we determine the necessary instrumentation and reagents necessary for CQA assays and define performance parameters on a preliminary basis.
Assay optimization
A series of experiments are conducted to confirm assay method parameters under different sample conditions. The data obtained from these experiments will be used to set acceptance criteria for our rapid service.
Assay Validation
The assay protocol is meticulously scrutinized. 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 also include inter-laboratory comparisons.
Development of assays are typically re-evaluated on an established schedule to confirm fidelity of performance. Methods are also reassessed as existing technologies are developed, regulatory supervisions are updated, or any other factors arise that may necessitate a change in methodology. For a quote or technical advice from PackGene, please provide specific project details.
Resources
Are pH measurements required, and is a large amount of sample wasted to carry out pH measurements?
Measurement of pH is a mandatory for the release of rAAV Fast Service deliverables. A micro pH electrode may be used to save sample and thus the required sample volume to perform pH measurements is only ~15uL-100uL.
What is loading?
In accordance with the Pharmacopoeia General Rules 0942, we use the minimum filling quantity inspection method for detecting sample loading quantity.
How to interpret A260/A280 value?
A260/A280 is the ratio of sample absorbance measured at wavelengths of 260nm and 280nm. This measure is commonly thought to represent the ratio of DNA to protein in a sample. For rAAV, A260/A280 can used as a measure of the full to empty shell rate and to identify protein contamination. Low A260/A280 levels may suggest that the empty shell rate is high. Alternatively, high A260/A280 may suggest that the sample has been contaminated with proteins that are not incorporated into the AAV capsid shell. The greatest advantages of this measure are its convenience and speed.
What tests are performed to differentiate rAAV capsid proteins from specific protein impurities?
SDS-PAGE is used to identify rAAV capsid proteins. In addition, SDS-PAGE can be used to directly identify specific protein impurities including the presence of host proteins, BSA, or degraded AAV capsid proteins.
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