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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.

Interested in our AAV services? Please contact us for a free consultation or  submit a request for a quotation.
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.