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Plasmid DNA Viral Vectors Recombinant Protein Cell Therapeutics aseptic.html Quality Assurance & Control

Plasmid DNA

The WCBF has developed a process for the production of multi-gram quantities of clinical grade plasmid DNA utilizing scalable equipment and techniques that conforms to industry standards for sanitary design.  In addition, no enzymes or organic solvents are utilized in the WCBF process and equipment that is utilized is typically available in large-scale versions to allow simplified process scale-up for future needs.

The WCBF plasmid production process is outlined below

  1. Plasmid Fermentation >
  2. Isolation by Centrifugation >
  3. Modified Alkaline Lysis and Solid/Liquid Separation >
  4. Purification/Chromatography #1 >
  5. Purification/Chromatography #2 >
  6. Buffer Exchange, Concentration >
  7. Dilution to Desired Concentration >
  8. Sterile Filtration

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