Plasmid cGMP Manufacturing
PackGene provides plasmid manufacturing under cGMP conditions for multiple treatments. Our new segregated ISO-classified plasmids manufacturing suite(1000m2) start to go into full operation in September, 2021.
Interested in our Plasmid One-Stop solution services? Contact us for a free consultation or Request a quote.
Plasmid Manufacturing Facilities
PackGene’s fermentation scale ranging from 50L to 200L with single-use technologies. GMP plasmids are wholly separated from other plasmids and plasmid-bearing materials by physical barriers to maintain isolated manufacture conditions. We conduct full room changeover after finishing one batch.
Plasmid cGMP Product
√ Bacteria Bank Generation
√ Single-use fermentation (50L to 200L)
√ Ultra-filtration & AKTA ready purification system
√ Quality Inspection
√ Batch record, manufacturing summary 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 |
Our Advantages
- Designed with QbD concept and optimization
- Clean environment in accordance with C+A standards
- Isolated vector producing line to completely avoid cross-contamination between different plasmids
- GMP-compliant pilot production cycle can be shortened to 1-2 months
- Single-use technology and water supply to ensure batch cleaning verification
General inquiry
- Fast Service inquiry
- Service inquiry
- New fast service information
Technical support
- Fast Service selection
- Application & solution
- Troubleshooting
Request a quote
- Customization service
- Tailored services
- Pricing inquiry