GMP AAV Batch Release Testing
Secure Your Path to the Clinic with Validated, IND-Ready Analytics
Key Benefits for Clinical Manufacturing
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Accelerated Lot Release
Our integrated "Make-and-Test" model allows for real-time analytics alongside manufacturing, significantly reducing release timelines compared to outsourced models. -
Regulatory Readiness
All assays are qualified or validated per ICH Q2(R1), supporting IND and BLA submissions with robust, defendable data packages. -
Comprehensive CQA Coverage
We address every Critical Quality Attribute (CQA) required for human administration—from mandatory compendial safety tests to advanced capsid analytics. -
Expert Guidance
Leverage technical expertise that supports over 35 clinical programs worldwide, ensuring your testing strategy aligns with the latest regulatory expectations.
Comprehensive GMP Release Panel
We offer a rigorous panel of 60+ qualified and validated assays covering every Critical Quality Attribute (CQA) required for human administration.
Table 1: Standard GMP Release Assay List
A selection of our qualified methods available for IND/BLA submission.
| Test Category | Critical Quality Attribute (CQA) | Method | Standard/Guideline |
|---|---|---|---|
| Safety | Sterility | Direct Inoculation | USP <71> |
| Endotoxin | Kinetic Chromogenic / LAL | USP <85> | |
| Mycoplasma Detection | qPCR | USP <63> | |
| Replication Competent AAV (rcAAV) | Cell-based Assay + qPCR | FDA Recommended | |
| Subvisible Particles | Light Obscuration | USP <788> | |
| Potency | Genomic Titer (Physical) | ddPCR (Digital Droplet PCR) | Validated |
| Infectious Titer (Biological) | TCID50 Cell-Based Assay | Validated | |
| Total Particle Titer | Capsid ELISA / HPLC | Validated | |
| Purity | Empty / Full Capsid Ratio | Analytical Ultracentrifugation (AUC) | Gold Standard |
| Aggregation (HMW) | SEC-HPLC | Validated | |
| Capsid Protein Purity | SDS-PAGE / CE-SDS | Validated | |
| Identity | Genomic Integrity | Nanopore Sequencing / CE | Validated |
| Capsid Identity | Peptide Mapping / Western Blot | Validated |
Performance Case Study: High-Purity AAV
Our manufacturing and testing platforms consistently deliver drug substance (DS) and drug product (DP) that exceed industry standards. The data below represents typical release results from our GMP production lines.
Table 2: Typical GMP Batch Release Data
Data derived from recent clinical AAV manufacturing campaigns
| Critical Quality Attribute | Actual GMP Data (PG_C001Batch A) | Actual GMP Data (PG_C001 Batch B) |
|---|---|---|
| Appearance | Conforms | Conforms |
| pH | 7.3 | 7.3 |
| AAV Purity (HPLC) | 99.10% | 98.54% |
| Aggregation (SEC-HPLC) | 0.90% | 1.45% |
| Empty/Full Ratio (AUC) | 97.36% Full | 94.70% Full |
| Genomic Titer (ddPCR) | 1.63 × 10¹³ vg/mL | 1.19 × 10¹³ vg/mL |
| Residual Host DNA | 3.62 ng | 3.07 ng |
| Residual Host Protein | 1.81 ng | 1.77 ng |
| Replication Competent AAV | < 1 rcAAV | < 1 rcAAV |
| Endotoxin | < 0.4 EU/mL | < 0.4 EU/mL |
Visualizing Product Quality
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Figure 1: Empty/Full Capsid Ratio by AUC The Regulatory "Gold Standard" for Purity.
Learn more about AAV Empty/Full Capsid Ratio Test by AUC.
Analytical Ultracentrifugation (AUC) provides high-resolution separation of capsid species. As shown in these consecutive GMP batches, our process achieves industry-leading purity with 97.36% and 94.70% full capsids. The sharp peaks confirm effective removal of empty particles and high homogeneity.
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Figure 2: Aggregation Analysis by SEC-HPLC Confirming Safety and Monodispersity.
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Figure 3: Capsid Identity & Purity by SDS-PAGE Visual Verification of Viral Proteins.
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Figure 4: Genomic Titer by ddPCR Absolute Quantification for precise dosing.
Visualizing Product Quality
Ensuring your product remains stable and safe throughout its shelf life is critical for clinical success.
Table 3: Residual Impurity Clearance
Validated assays ensure process residuals are removed to safe levels for human administration.
| Impurity Type | Target Residual | Method | Real-World Result (PG_C001) |
|---|---|---|---|
| Host Cell | HEK293 DNA | qPCR | Passed (< 4 ng) |
| HEK293 HCP | ELISA | Passed (< 2 ng) | |
| Process Additives | Benzonase (Nuclease) | ELISA | Not Detected |
| Poloxamer 188 | HPLC | 8.63 mg/L | |
| Transfection Reagent | HPLC | Not Detected | |
| Affinity Ligand | ELISA | 0.20 ng |
Contact our Technical Team to discuss your specific CQA requirements and transfer your assays today.
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AAV Testing Services
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GMP Plasmid
- cGMP plasmid production up to 200L, with flexible scaling for any project size.
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GMP AAV Manufacturing
- High-productivity GMP AAV manufacturing with a scalable production platform.
- Cost-effective solutions featuring in-house GMP plasmid manufacturing and comprehensive release testing.
- Rapid timeline to GMP AAV production and clinical application, backed by a strong record of successful delivery.
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Process Development
- Optimized high-yield processes using data-driven DoE
- Customized solutions with seamless GMP scale-up
- IND-ready data documented in electronic lab notebooks
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AAV Analytical Development
- Comprehensive testing for identity, purity, potency, and safety
- Custom, validated assays aligned with regulatory needs
- Fast turnaround with GMP-grade QC and release support
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