Plasmid DNA Manufacturing

We have a significant experience and expertise in the large-scale production of plasmid DNA for various uses.

We manufacture GMP plasmid DNA starting material to be used in the production of viral vectors (e.g. lentivirus and AAV) or in vitro transcribed-RNA (IVT-RNA) (e.g. mRNA, long RNA)

We also produce plasmid DNA API for use as a DNA Vaccines or therapeutic non-viral plasmid DNA mediated gene therapy applications.

kb plasmid experience


For human clinical trials and commercialization

All GMP material is produced in accordance to FDA 21 CFR Part 210 & 211, EU 2003/94/EC, Eudralex Vol 4, and relevant ICH; the regulatory requirements for sterile injectable products intended for human clinical trials and commercialization.

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GMP Plasmid DNA to kg-scale

We manufacture custom Plasmid DNA vaccines for gene therapy.

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

Why work with us?

Experience

  • Experience manufacturing for Phase I, II and III clinical trials
  • 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 1-10 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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Scalable process from g to kg

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 manufacture plasmid DNA for big pharma companies worldwide.

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Non-viral gene therapy

We offer expertise in non-viral DNA vector development and GMP manufacturing for human or veterinary use.

We have already produced plasmid DNA API at the 200g scale using a 350L working volume fermenter with plans to scale-up to kg-scale.

Starting Materials

We have experience in the production and quality control of difficult to produce plasmid DNA such as sequences that contain duplicate genes of interest, inverted terminal repeats (ITR), long terminal repeats (LTR) or polyA tails.

Our very large-scale plasmid manufacturing capabilities are particularly interesting for the reduction of cost of goods for helper plasmids that can be used in multiple viral vector production projects.