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Plasmid cGMP Manufacturing

PackGene provides plasmid manufacturing under cGMP conditions for multiple treatments. Our new segregated ISO-classified plasmids manufacturing suite(1000m2) start to go into full operation in September, 2021.

Interested in our Plasmid One-Stop solution services?    Contact us for a free consultation or Request a quote.

Plasmid Manufacturing Facilities

PackGene’s fermentation scale ranging 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 manufacture conditions. We conduct full room changeover after finishing one batch.

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)
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

Our Advantages

  • 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
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  • Service inquiry
  • New fast service information
Technical support
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  • Application & solution
  • Troubleshooting
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