Home > CDMO Services > Plasmid Services > Plasmid Non-GMP Manufacturing

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. Our Non-GMP services guarantee a consistent production process with large scale manufacturing. PackGene’s non-GMP plasmid product are widely applicable to different research depends on your research, such as early research and animal studies, preclinical studies including pharmacodynamics and toxicology studies, etc.

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 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
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

Advantages of our Plasmid Non-GMP manufacturing

  • Productivity: Up to 10L scales bioreactor available, could provide up to 0.5-1.5g of plasmid per batch.
  • Fast and cost-saving supply: Not only with our competitive price and guaranteed product quality, our plasmid supply period can also be shortened to within one month. 
  • Experts team on site: PackGene has a professional plasmid production team with members who have more than 10 years of experiencein related area.