AIRMIX®

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AIRMIX®
Technology for production of high-quality plasmid DNA
A technology that isolates high concentrate/high purity plasmid from host cells, E. coli in the cell lysis step
in the large-scale plasmid manufacturing process.
Our company's international patent US20090004716
AIRMIX® - A Softer, Gentler Lysis
Mixing the cells with lysis solution with bubbles
- As the cell solution runs through our patented "bubble column" mixer, special chemicals in the lysis solution
  cause host cell impurities to tangle, and host cell impurities then float to the top of the lysis solution. The
  solution containing the plasmid is pulled off the bottom of the tank for further processing.
- The bubbles gently separate the lysed cellular components [E. coli host cell impurities (genomic DNA/protein/
  RNA/endotoxin) and plasmid DNA].
Features and Advantages of AIRMIX®
Shortening of plasmid DNA production time
- It used to take 2~3 days to lysis a large scale batch, it now takes only 4 hours through automated AIRMIX®
  process.
Production of high-quality plasmid DNA.
- In AIRMIX® cell lysis step, the lysate containing plasmid is not subjected to any high shear in order to
  minimize shearing of plasmid or genomic DNA.
- AIRMIX® lysis process removes over 99% of cellular and genomic DNA contaminates simplifying downstream
  purification.
- AIRMIX® lysis process enables us to produce plasmids at concentrations as high as 15 mg/mL, while most
  other CMOs can only achieve concentrations in the 3~5 mg/mL range because of high genomic DNA
  contamination.
(e.g. pGX6005 plasmid)
Plasmid bulk
concentration
(g/L)
Supercoiled
form (%)
gDNA (%) Endotoxin
(Eu/mg)
RNA (%) Protein (%)
12.8 99 0.02 ≤0.6 ≤0.1 ≤0.01
Certificate of Analysis for GLS-5700 (Zika DNA Vaccine)
Evaluation Specification Result
Nucleic Acid Concentration 10.0 ± 0.5 mg/mL 10.0 mg/mL
Purity by A260/280 1.8 - 2.1 2.0
Identity Conforms to Specification Conforms to Specification
Total Supercoil Forms ≥ 90% 97%
Total Circular Forms ≥ 95% 98%
Endotoxin < 5 EU/mg ≤ 0.1 EU/mg
Osmolality Report 334 mOsm/kg H2O
pH Report 7.2
Transcriptional Activity Positive Positive
Appearance Clear, colorless solution essentially free of visible particulate matter Clear, colorless solution essentially free of visible particulate matter
Sterility Conforms Conforms
Particulate Matter in Injections ≤ 6000 Particles
≥ 10 μm per Container
101 Particles
Particulate Matter in Injections ≤ 600 Particles
≥ 25 μm per Container
1 Particles