AAV Analytical QC Services
As a leading gene therapy AAV CDMO, we recognize that maintaining a robust and reliable quality control system in both process development and production is a must. PackGene has a highly skilled and experienced team dedicated to developing and delivering QC assays for plasmid and AAV production. Our analytical QC services offer a wide range of testing assays to meet the stringent QC requirements of your projects from raw materials, stock solution, harvested solution, to the final products.
PackGene has developed comprehensive range of AAV-based QC assays in-house to ensure the identity, purity, content/potency and safety of the AAV products under GMP conditions, leading to consistent quality at every stage.
|Visible foreign matter||Visual inspection|
|Osmolality||Molar concentration method|
|Loading capacity||Volume method|
|Plasmid identity||Sanger Sequencing|
|Target gene expression||ELISA|
|Impurity||Host DNA residue||qPCR|
|Host DNA Fragment size||qPCR|
|Exogenous DNA residue||ddPCR|
|Transfection residue||Assay developing|
|Safety Tests||Sterility test||Membrane filtration|
|Exogenous viral factor||Animal experiments|
|Abnormal toxicity||Animal experiments|
- Assay development. The data to be collected is identified and the necessary instrumentation, reagents (and/or kits) are selected for a specific assay. The performance parameters are outlined on a preliminary basis.
- Assay optimization. During phase, a series of experiments are conducted in order to document how various sample and assay conditions affect assay performance. This information will be used to set the acceptance criteria for rapid service phases.
- Assay qualification. The qualification phase aims to demonstrate that the optimized method provides meaningful data for the specific samples and under the same conditions to be used when the method is fully applied. The protocol is formalized and circulated for review and discussion. Following approval, the protocol is tested and a written report is compiled in which all results, analyses, and conclusions are outlined. The report is then circulated for final approval before the method implementation.
- Assay Validation. The protocol is reviewed under the same procedure as in the qualification phase, but in a more comprehensive manner. The performance of the assay is documented with respect to accuracy, linearity, range, limit of detection (LOD), limit of quantitation (LOQ), specificity/selectivity, precision, and suitability. Validation may include inter-laboratory comparisons as well.
GMP 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 develop, regulatory are updated or any other factors arise that may necessitate a method change in methodology.
PackGene can provide GMP AAV assay and QC services for your project. Please provide specific project details to get a quote or technical advice from PackGene.