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cGMP AAV Assay & QC Services

Quality control (QC) is so critical for gene therapy CDMO that makes the maintaining of a robust and reliable QC system a must in both production and application. PackGene is highly devoted to AAV GMP manufacturing and quality control for AAV-based products. PackGene has a highly skilled and experienced team for GMP QC technology to develop and deliver QC assays for plasmid and AAV products. Our QC technology employs multiple assays to meet the requirements of your projects. We offer a variety of assays and methods for you to choose and combine a multimerized GMP assay service from raw materials, stock liquid, harvested liquid, to the final products.
PackGene has developed systematic AAV-based assays, including identification, verification and qualification to ensure our AAV products under GMP condition to attain the consistent quality at every stage. Here are list of the assays and methods.

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Category Assays Method
General appearance Visual inspection
visible foreign matter Visual inspection
pH pH indicator
osmotic pressure Molar concentration method
loading capacity Volume method
Identifications capsid identification SDS-PAGE
gene sequence Sanger Sequencing
Purity Protein SDS PAGE
A260/A280 UV
HPLC Purity HPLC
Content/Potency Genome titer ddPCR
Infection titer TCID50
Target gene expression ELISA
Impurity Host DNA residence qPCR
HCP ELISA
Plasmid DNA residence ddPCR
BSA residence ELISA
Nuclease residue ELISA
Plasmid residue ddPCR
rcAAV qPCR
Shell rate HPLC
Transfection residue Assay developing
antibiotic residue ELISA
Safety Tests Sterility test Membrane filtration
Exogenous viral factor Animal experiments
Abnormal toxicity Animal experiments
Mycoplasma Direct cultivation
Bacterial endotoxin Limulus reagent
rcAAV qPCR+Cell assay
RCR/RCL PCR
PackGene provides implementation of new assays that follows through several stages: development, optimization, qualification, and validation. The differentiations are.
  • 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. In this 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 product phases.
  • Assay qualification. The qualification phase is designed 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 assay methods are typically reevaluated on a set schedule, to confirm that they are continuing to perform as originally intended. Methods are also reassessed as available technologies developing, regulatory update or any other factors arise that may necessitate a method change.

PackGene quality control laboratory
HPLC assay platform for AAV purity and empty shell rate assay

PackGene can provide GMP AAV assay and QC services for your project. Please provide certain project details to get a quote or technical recommendations from PackGene.
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