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Plasmid Non-GMP Manufacturing

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PackGene provides flexible and reliable plasmid non-GMP production services ranging from 2L to 10L fermentation with downstream processing including ultrafiltration and chromatography. PackGene’s non-GMP plasmid products are widely applicable to early research, in vivo animal studies, and preclinical studies including pharmacodynamics and toxicology assessments.

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 document preparation
  • CoA

Non-GMP Plasmid Manufacturing Workflow

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

  • High Productivity: Up to 10L scales bioreactor is capable of providing 5-1.5g of plasmid per batch.
  • Fast Turnaround: Plasmid production periods can be less than one month.
  • Cost Efficient: Our standardized and efficient processes allow us to provide competitive pricing.
  • Expert Team: PackGene has a professional plasmid production team with members who have more than 10 years of experience in plasmid preparation.