Plasmid cGMP Manufacturing
PackGene provides GMP-grade plasmid manufacturing services for multiple treatments, including cloning, amplification and purification of plasmid vectors to support subsequent GMP-grade AAV production and other applications. Our new segregated ISO-classified plasmids manufacturing suite(1000m²) start to go into full operation from 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 on request, using PackGene’s proprietary vector backbone. We also provide complete upstream and downstream process development support for specific plasmid production. We offer both research grade and GMP grade plasmids for different needs. Scientific plasmids are used for routine transfection experiments, viral transduction, gene therapy, etc. GMP plasmids are used for plasmid-based gene therapy or AAV pilot or mass production.
Plasmid Manufacturing Facilities
PackGene’s fermentation scale ranges from 50L to 200L with single-use technologies. GMP plasmids are wholly separated from other plasmids and plasmid-bearing materials by physical barriers to maintain isolated manufacturing conditions. We conduct a full room changeover after finishing one batch.
PackGene produces plasmids in 1L-50L fermentation systems using “single-use technology”. The plasmid production process is done in a separate dedicated production room, which is physically separated from other plasmid and plasmid bearing materials to maintain separate and clean production conditions.
After each batch of specialty service is completed, we clean and maintain the entire room facility, including thoroughly cleaning surfaces and all non-disposable equipment, prior to the start of the next GMP plasmid program, and we use disposable materials for most critical procedures, significantly reducing the chance of contamination of the specialty service.
Plasmid cGMP Product
√ 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)
|General Characterization||Appearance||Visual inspection|
|Identity||Restriction Digest||Agarose gel electrophoresis|
|Plasmid Sequence||Sanger Sequencing|
|Content||DNA Concentration||UV spectrophotometry(A260)|
|Purity||UV Purity||A260/A280 ratio|
|Impurity||Residual Host Cell DNA||qPCR|
|Residual Host Cell RNA||Agarose gel electrophoresis|
|Residual Host Cell Protein||ELISA|
|Sterility Test||Direct Inoculation Method|
- Designed with QbD concept and optimization
- Clean environment in accordance with C+A standards
- Isolated vector producing line to completely avoid cross-contamination between different plasmids
- GMP-compliant pilot production cycle can be shortened to 1-2 months
- Single-use technology and water supply to ensure batch cleaning verification