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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.

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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
 √       CoA

Research grade vs. Non-GMP Grade
Plasmid Research Non-GMP
Fermentation Bioreactor
Extract Kit Purification ×
Chromatography Purification ×
Data Traceability ×
Compliance ×
Manufacturing Summary Report ×
Testing Report
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

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.

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