GMP Plasmid DNA

GMP Plasmid Highlights

  • High yield fermentation
  • No enzymes or organic solvents
  • Scalable production process
  • Multi-gram capacity
  • DNA vaccines, gene therapy, or ex-vivo applications

Working in close contact with clients, Waisman focuses to design a tailored fermentation and purification process for manufacture of your GMP plasmid DNA molecule. Our novel protocol yields up to multi-gram quantities of clinical grade plasmid DNA that can be used for DNA vaccines, gene therapy, or ex-vivo applications. 

We recognize that both time and budget are client concerns and these are prioritized in project management. In addition, Waisman has licensed fermentation technology from Nature Technology Corporation that has been used to increase expression of some plasmids up to 2.5 grams/liter.  (Facility/Microbial Suites).

Plasmid Production Specifics

  • Master Cell Bank/Working Cell Bank capabilities
  • Scaleable equipment/techniques employed facilitating tech transfer and production of large product lots
  • No enzymes or organic solvents used in process
  • Streamlined fermentation methods maximizing plasmid yields
  • Fermentor 30L capacity
  • Column chromatography and TFF methods maximizing product purity and recovery
  • Qualified Aseptic Fill capabilities

Typical Plasmid Process Outline

Step

Process

1

Fermentation

2

Isolation by Centrifugation

3

Modified Alkaline Lysis and Solid/Liquid Separation

4

Purification/Chromatography

5

Buffer Exchange, Concentation

6

Dilution to Desired Concentration

7

Sterile Filtration

Typical Project Time Line

Process Step

Time to Completion

Master Cell Bank Production

2 weeks

Master Cell Bank Testing

2- 4 weeks

Fermentation

1-2 weeks

Downstream Purification

2-3 weeks

Aseptic Fill/Finish

1 week

Release Testing

4-6 weeks