BioPharmaceuticals Production

GMP Plasmid DNA Manufacturing

We produce GMP Plasmid DNA for starting material, or API since 2004.

We have developed a platform production process that provides GMP grade plasmid in scales from gram to kilogram that is recognized by numerous big pharma companies for quality and scalability.

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Why work with us?

Innovative scalable process

Plasmid manufacturing from 80L to 2200L scale

We manufacture plasmid up to the kg scale with lower quantities of raw materials, volumes of solvents and waste.

We currently manufacturing plasmid DNA for big pharma companies worldwide.

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GMP Plasmid DNA to kg-scale

Our 2200L fermenter combined with our purification process allow the production of plasmid DNA to the kilo-scale for commercial uses.

Experience

  • Plasmid experience from 2.5-16.5 kb
  • Numerous antibiotic-free plasmid technologies
  • High yielding, high purity proprietary one-chromatography-step purification technology

 
 

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Quality

  • Manufacturing in US FDA inspected facility, inspected 2011, 2013, 2014, 2017
  • Drug Master File (DMF) in place with US FDA for easy CMC dossier submission
  • Platform GMP plasmid DNA production, scalable for early clinical to commercial
  • Non-animal origin materials

 

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Quantity

  • Batch sizes up to kg scale manufacturing
  • Plasmid concentration from 1-15 mg/ml
  • High yielding licensed HyperGro® fermentation technology
  • High yielding, high purity proprietary one-chromatography-step purification technology yielding plasmid DNA exceeding FDA quality guidelines

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