Plasmid cGMP Manufacturing
PackGene provides GMP-grade plasmid manufacturing services for cloning, amplification, and purification of plasmid vectors to support subsequent GMP-grade AAV production as well as other applications. Our new segregated ISO-classified plasmid manufacturing suite (1000m²) is fully operational as of September 2021. We provide GMP-grade plasmid vector cloning, amplification and purification services and cover large-scale fermentation, material isolation, full traceability documentation control and comprehensive quality control assays.
Plasmid Production Service
PackGene’s plasmid production allows for the use of existing plasmids provided by the customer, as well as the reconstitution of plasmids using PackGene’s proprietary vector backbone. We also provide complete upstream and downstream process development support for specific plasmid production.
Plasmid Manufacturing Facilities
PackGene’s cGMP fermentation scale ranges from 50L to 200L with single use fermentation units. GMP plasmids are wholly separated from other plasmids and plasmid-bearing materials by physical barriers to maintain separate and clean production conditions.
After each production batch is completed we clean and maintenance the entire facility room. This includes thoroughly cleaning surfaces and all non-disposable equipment prior to the start of the next GMP plasmid production run. In addition to this cleaning regimen, and we use disposable materials for most critical procedures to significantly reduce the chance of contamination.
GMP Plasmid Manufacturing Workflow
Plasmid cGMP Product Advantages:
- 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 |
PackGene’s Advantages:
- Designed with Quality by Design (QbD) concept and optimization
- Clean environment in accordance with C+A standards
- Isolated vector production line to completely avoid cross-contamination
- GMP-compliant pilot production cycle can as fast as 1-2 months
- Single-use technology and water supply to ensure throurough cleaning between batches
