Plasmid Non-GMP Manufacturing
Packgene provide flexible and reliable plasmid Non-GMP production services ranging from 2L to 10L fermentation with purification by ultrafiltration and chromatography. Our Non-GMP services guarantee a consistent production process with large scale manufacturing. Packgene’s non-GMP plasmid product could be adapted to early research and animal studies, preclinical studies including pharmacodynamics and toxicology studies, etc.
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 focument preperation
Research grade vs. Non-GMP Grade
|Extract Kit Purification||√||×|
|Manufacturing Summary Report||×||√|
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|
Advantages of our Plasmid Non-GMP manufacturing
Productivity: Up to 10L scales bioreactor available, could provide up to 0.5-1.5 g of plasmid per batch.
Fast and cost-saving supply: Packgene provide plasmid services with a competitive prices. Our plasmid supply can be shorten to within one month.
Professional: Packgene has a professional plasmid production team with more than 10 years of experience.