AAV GMP-like Manufacturing
GMP-like is a faster and more cost-effective alternative to cGMP production, which can be produced in accordance with standard or customizable specifications. GMP-Source AAV can be applied on preclinical studies, IIT, etc.
Interested in our AAV services? Contact us for a free consultation or Request a quote.
AAV GMP-like Product
√ 50L to 500L single-use bioreactor for suspension culture
√ Pall icellis 500 m2 adherent bed（66m2-500 m2）for adherent culture
√ Ultra-centrifugation (optional) & AKTA Ready/Pilot purification system
√ Quality Inspection
√ Batch record, manufacturing summary report, CoA
AAV Quality control (or customized based on specific process)
| Specification | Assay Methods | |
| Identity | GOI Sequence | Sanger Sequence |
| AAV Capsid | SDS PAGE/MS | |
|
Purity
|
HPLC Purity | HPLC |
| UV Purity | A260/A280 | |
| %Empty capsids | AEX HPLC | |
| TEM | ||
| AUC | ||
| Aggregation | DLS | |
| Potency & Content | Capsid Titer | ELISA |
| Genome Titer | ddPCR | |
| Infectious Titer | TCID50 | |
| Protein Expression | In Vitro assay | |
| Impurity | Residual Host Cell DNA | qPCR |
| Residual E1A | qPCR | |
| HCP Residue | ELISA | |
| BSA Residue | ELISA | |
| Residual Plasmid | ddPCR | |
| Residual Nuclease | ELISA | |
| Residual Iodixanol/CsCl | HPLC | |
| Residual Ligand | ELISA | |
| Safety | Mycoplasma | qPCR/Mycoplasma culture /DNA staining |
| rcAAV | Cell Assay+qPCR | |
| Bacterial endotoxin | LAL | |
| Sterility | Direct Inoculation Method/Membrane filtration | |
| Adventitious agent | Cell Culture | |
| Abnormal toxicity | Animal test | |
| General Characterization | Appearance | Visual Inspection |
| Content | Minimum Fill | |
| pH | pH Method | |
| Osmolality | Osmometers | |
| Particulate matter | Light Obscuration Particle Count test |
General inquiry
- Fast Service inquiry
- Service inquiry
- New fast service information
Technical support
- Fast Service selection
- Application & solution
- Troubleshooting
Request a quote
- Customization service
- Tailored services
- Pricing inquiry