Plasmid Production Service
With 80 years of experience in the fermentation business, we specialize in manufacturing APIs under cGMP for the global market. We have extensive supply records with leading pharmaceutical companies in the US, EU, and Japan, and have been audited by regulatory agencies such as the FDA, TGA, and PMDA. We offer reliable, stable, and affordable plasmid production from lab scale to commercial scale, ensuring high-quality supply throughout the process.
Why MBJ's Plasmid?
- Grade: from Research Grade to GMP
- Capacity: from 3 L to 2000 L
- High productivity: >1 g/30 L tank, >10 g/300 L tank
- High purity: 90-95% as SC (supercoiled)
- Lead time: Non-GMP 2 months, GMP 6 months
Customer's Feedback
- Low Price & High Productivity
- High quality/stability
- Experience of large scale production
- Reliable company based on long track record
etc.
Plasmid Grade
| Production Conditions | Research Grade | GMP (From Apr. 2024) |
|---|---|---|
| GMP Requirement | Non-GMP | GMP |
| Manufacturing Site | MBJ labs | SUS: 30 L, 90 L SUF: 300 L |
| Production Environment | Non-GMP lab | GMP Clean room suite |
| Batch Size | ~ 1 g (up to 30 L) | ~ 1 g (30 L) ~ 10 g (300 L) |
| Lead Time | 2 months | 6 months |
| GMP Cell Bank | - | ○ |
| Product Analysis | Result of Analysis | Certificate of Analysis |
| Release Tests | - | ○ |
| Quality Assurance | - | ○ |
| Document Support | - | ○ |
Quality Control
| Assay | Method |
|---|---|
| DNA Concentration | UV spectrophotometric method |
| Endotoxin | Kinetic chromogenic LAL |
| DNA Purity | UV spectrophotometric method |
| Restriction Digest | EtBr stained agarose gel electrophoresis |
| Residual Host Genomic DNA | Q-PCR method |
| Residual Host Protein | BCA method |
| Residual Host RNA | Fluorescence spectroscopy |
| Bioburden | Membrane filtration method |
| DNA Homogeneity (SC ratio) | Capillary electrophoresis |
| Plasmid Identity | Sanger method |
| Identity by T5 Degestion and Densitometry | Agarose gel slectrophoresis |
| Appearance | Visual inspection |
