AAV Analytical QC Services
Ensuring Quality at Every Step, From Development to Delivery
Key Benefits
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Comprehensive testing
Purity, potency, safety, impurities -
Custom assay development tailored to your needs
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Regulatory compliance
Qualified, validated assays for Phase-appropriate risk -
Quality control
Pre-defined release criteria for GMP batches -
Quick turnaround
Time-sensitive solutions -
In-depth analytical support for identity, purity, potency, and safety
Service Details
PackGene offers comprehensive services for the development, optimization, validation, and implementation of quality control assays tailored to your specific project needs. Our assay services include:
- Development: We design assays to confirm critical quality attributes (CQA) based on Quality by Design (QbD) principles, determining necessary instrumentation, reagents, and performance parameters.
- Optimization: Experiments are conducted to confirm method parameters under various sample conditions, with data used to establish acceptance criteria for rapid service.
- Validation: We rigorously validate assay protocols, documenting performance in terms of accuracy, linearity, detection limits, specificity, precision, and suitability, with potential inter-laboratory comparisons.
Assays are re-evaluated regularly to ensure performance consistency, and methods are updated as technologies evolve or regulatory requirements change. For a quote or technical advice, please provide specific project details.
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PackGene provides a wide range of off-the-shelf characterization assays for immediate use, ensuring a quicker turnaround for your project.
| Assay | Methods |
|---|---|
| Titration & Genome Integrity | AAV Genome Titration -ddPCR |
| AAV Capsid Titration Infectious Titer -TCID50 | |
| AAV Genomic Integrity -CE | |
| AAV Genomic Sequencing -TGS | |
| AAV Identity by Sanger sequencing | |
| Alkaline Gel Electrophoresis | |
| Capsid characterization, purity, aggregation | AAV Empty Capsid Rate -AUC |
| TEM (5 pictures) +report | |
| DLS (Dynamic light scattering) | |
| AAV Capsid Peptide Mapping | |
| Capsid Protein Molecular Weight and Ratio | |
| Capsid purity Analysis -SDS-PAGE | |
| Capsid purity Analysis -CE-SDS | |
| Purity Analysis -AEC-HPLC | |
| Purity and Aggregation Analysis -SEC-HPLC | |
| Contamination | Residual Host HEK293 Cell DNA Quantification |
| Residual HEK293 Host Cell DNA | |
| Residual Plasmid DNA | |
| Residual E1A | |
| Residual Host Cell Protein | |
| Residual BSA | |
| Residual Nuclease | |
| Residual Affinity Ligands | |
| Residual PEI | |
| Residual Tween20 | |
| Residual Triton X100 | |
| Residual Iodixanol | |
| Residual Poloxamer 188 | |
| Residual Triton Analysis | |
| Safety | Endotoxin removal |
| Sterility test | |
| Mycoplasma detection | |
| Endotoxin test | |
| Quantitative Endotoxin test | |
| Bioburden Test | |
| Mycoplasma detection by qPCR | |
| Replication Competent AAV (rcAAV) Analysis |
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Confidentiality Commitment from PackGene:
The information you submit here will be kept strictly confidential. Packgene will not disclose to any third party or related personnel, and it will only be used for project evaluation and progress reports according to the requests from submitter under confidentiality conditions.