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Preclinical studies aim to obtain information about the biological efficacy and safety of a drug candidate before testing it in humans. There are many similarities between non-human primates (NHPs) and humans in physiology, anatomy, immunology and neurology, which makes NHPs excellent models for addressing several human genetic diseases that can not be addressed using other species, for example, models of acquired immunodeficiency syndrome (AIDS), lung disorders and drug metabolism. The Food and Drug Administration (FDA) requires researchers to use good laboratory practices (GLP) for preclinical laboratory studies. Compared with cGMP production, GMP-Like/GLP production is cost-effective and has a faster timeline.
Creative Biogene offers GMP-Like or GLP AAV manufacturing to assist your preclinical studies. The production process and quality controls of our GMP-Like manufacturing follow main guidelines of the GMP compliance to ensure reliability and reproducibility of results in preclinical studies and accelerate your research to clinic faster.
1. Preclinical pharmacodynamics studies
2. Preclinical efficacy testing
3. Preclinical toxicology studies
4. Preclinical drug safety and metabolism testing
5. Development of large animal models like Non-Human Primates (NHPs)
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 single-use bioreactor systems for suspension culture (50L to 500L) and fixed-bed bioreactor systems for adherent culture (66 to 500 m2).
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 (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 such as ultra-centrifugation, chromatography.
Our standard QCs 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 | <2 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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