Plasmid Non-GMP Manufacturing
PackGene provides flexible and reliable plasmid non-GMP production services ranging from 2L to 10L fermentation with downstream processing including ultrafiltration and chromatography. PackGene’s non-GMP plasmid products are widely applicable to early research, in vivo animal studies, and preclinical studies including pharmacodynamics and toxicology assessments.
Interested in our AAV services? Please contact us for a free consultation or submit a request for a quotation.
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 document preparation
- CoA
Non-GMP Plasmid Manufacturing Workflow
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
- High Productivity: Up to 10L scales bioreactor is capable of providing 5-1.5g of plasmid per batch.
- Fast Turnaround: Plasmid production periods can be less than one month.
- Cost Efficient: Our standardized and efficient processes allow us to provide competitive pricing.
- Expert Team: PackGene has a professional plasmid production team with members who have more than 10 years of experience in plasmid preparation.
