Plasmid GMP-like Manufacturing
GMP-like plasmid DNA is a faster and more cost-effective alternative to GMP production, which can be produced in accordance with standard or customizable specifications. GMP-Source plasmid DNA can be used as an auxiliary or key raw material for the production of protein and virus candidates for clinical trials.
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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 |
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