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Creative Biogene provides non-GMP large-scale AAV manufacturing with high quality that is suitable for basic research and early drug discovery studies. The non-GMP AAVs are produced in conventional cell culture facilities followed by strict quality controls to ensure the viruses can be used in both in vitro cell experiments and in vivo animal studies. We provide one-stop non-GMP AAV solution starting from vector design to large-scale virus manufacturing.
1. For in vitro cell transduction to study gene delivery efficiency, gene functions etc.
2. Development of mouse or rat disease animal models
3. Investigation of AAV-mediated gene therapy
Our professional molecular biologists can design fit-your-project AAV plasmid vectors. In combination with our state-of-the-art bacterial bioreactors, we can produce high quality and different scales of AAV plasmid vectors for downstream packaging cell transfection.
Creative Biogene owns glass bioreactors and single-use bioreactor systems at different volumes, ranging from 1L to 200L.
Creative Biogene has established PCB (Primary cell bank), MCB (Master cell bank) and WCB (Working cell bank) for AAV large-scale production. We can use either adherent conditions (Cell Factory or fixed-bed bioreactors) or serum-free suspension conditions (single-use bioreactors) depending on the requested virus amount.
Our professional teams have experience working with single-stranded AAV (ssAAV) and self-complementary AAV (scAAV) in multiple AAV serotypes, including but not limited to 1, 2, 3, 4, 5, 6, 6.2, 7, 8, 9, rh10, DJ, DJ/8, PHP.B, PHP.eB, PHP.S, AAV2-retrograde, AAV2-QuadYF, AAV2.7m8, AAV3b, AAVAnc80L65, AAV-ie, AAV Gp120, AAV ShH10, AAV Rh74.
We provide flexible purification methods for different downstream applications.
| Application | Purification Method |
| Cell transduction | Non-purified |
| Cell transduction & animal injection | Ultra-centrifugation or chromatography, or both |
Our standard QCs for Non-GMP AAV manufacturing include determining the virus titer by QPCR, verifying the virus purity by SDS-PAGE, and detecting endotoxin level. We also provide additional QC tests such as mycoplasma detection, TEM, sterility tests etc. Please contact us at 1-631-626-9181 or info@creative-biogene.com for more information.
| Category | Assay | Standard |
| Virus Potency & Content | QPCR Titration | >=1e13GC/mL* |
| Virus Purity | SDS-PAGE & Staining | The presence of three clear bands corresponding to AAV capsid proteins VP1, VP2 and VP3 |
| Impurity | Endotoxin detection | <10 Endotoxin Units (EU) |
AAV yield is varied depending on the serotypes. Representative data for AAV9 single batch yield is shown as below.
| Fermentation Volume | Typical Yield |
| 2 L | 1E+14GC |
| 50 L | 1E+16GC |
| 100 L | 2E+16GC |
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