Plasmid Non-GMP Manufacturing
Packgene provide flexible and reliable plasmid Non-GMP production services ranging from 2L to 10L fermentation with purification by ultrafiltration and chromatography. Our Non-GMP services guarantee a consistent production process with large scale manufacturing. Packgene’s non-GMP plasmid product could be adapted to early research and animal studies, preclinical studies including pharmacodynamics and toxicology studies, etc.
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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 0.5-1.5 g of plasmid per batch.
Fast and cost-saving supply: Packgene provide plasmid services with a competitive prices. Our plasmid supply can be shorten to within one month.
Professional: Packgene has a professional plasmid production team with more than 10 years of experience.
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