Plasmid GMP-like Manufacturing
PackGene’s GMP-like plasmid DNA manufacturing is a faster and more cost-effective alternative to GMP production. Our GMP-like plasmids are high quality plasmids produced following standard or customizable specifications. GMP-Like plasmid DNA can be applied as an auxiliary or key raw material for the protein or virus production for clinical trials.
Interested in our AAV services? Please contact us for a free consultation or submit a request for a quotation.
Plasmid GMP-Like Product
- Single-use fermentation (20L 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 |
