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. Our Non-GMP services guarantee a consistent production process with large scale manufacturing. PackGene’s non-GMP plasmid product are widely applicable to different research depends on your research, such as 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
Research grade vs. Non-GMP Grade
| Plasmid | Research | Non-GMP |
| Fermentation Bioreactor | √ | √ |
| Extract Kit Purification | √ | × |
| Chromatography Purification | × | √ |
| Data Traceability | × | √ |
| Compliance | × | √ |
| Manufacturing Summary Report | × | √ |
| Testing Report | √ | √ |
| 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.
