Plasmid Non-GMP Manufacturing
PackGene provides flexible and reliable plasmid non-GMP production services ranging from 2L to 10L fermentation with downstream processing including ultrafiltration and chromatography. PackGene’s non-GMP plasmid products are widely applicable to early research and animal studies, preclinical studies including pharmacodynamics and toxicology studies, etc.
Interested in our AAV services? Please contact us for a free consultation or submit a request for a quotation.
Plasmid Non-GMP Product
- Non-GMP bacteria bank generation
- Glass Bioreactor from 2L to 10L
- Ultra-filtration & AKTA Pure purification system
- Plasmid process development
- IND filing focument preperation
- CoA
Plasmid Quality Control (or customized based on specific process)
| Category | Items | Method |
| General Characterization | Appearance | Visual inspection |
| pH | pH meter | |
| Identity | Restriction Digest | Agarose gel electrophoresis |
| Plasmid Sequence | Sanger Sequencing | |
| Content | DNA Concentration | UV spectrophotometry(A260) |
| Purity | UV Purity | A260/A280 ratio |
| DNA Homogeneity | HPLC | |
| Impurity | Residual Host Cell DNA | qPCR |
| Residual Host Cell RNA | Agarose gel electrophoresis | |
| Residual Host Cell Protein | ELISA | |
| Residual Kanamycin | ELISA | |
| Safety | Endotoxin | LAL |
| Sterility Test | Direct Inoculation Method |
Advantages of our Plasmid Non-GMP Manufacturing
- Productivity: Up to 10L scales bioreactor available, could provide up to 0.5-1.5g of plasmid per batch.
- Fast and cost-saving supply: Not only with our competitive price and guaranteed product quality, our plasmid supply period can also be shortened to within one month.
- Experts team on site: PackGene has a professional plasmid production team with members who have more than 10 years of experiencein related area.
