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GMP Plasmid DNA

GMP plasmid DNA

Eurogentec Biologics offers a comprehensive gene to injectable service in the field of biopharmaceutical API development and manufacturing that includes cell line development, process development/optimization, GMP cell banking and GMP Drug Substance/API manufacturing. We have been manufacturing GMP biologics since 1994 and to date have produced over 140 different biopharmaceuticals and released over 500 GMP batches.

We manufacture GMP plasmid DNA API for use as starting material for the production of viral vectors (lenti and AAV) or for use as therapeutic non-viral plasmid DNA mediated gene therapy. All material is produced in accordance 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.

Features & Benefits

  • Platform API plasmid DNA production, scalable for early clinical to commercial

  • Plasmid sizes from 2.5-10 kb

  • Plasmid concentrations from 1-15 mg/ml

  • High yielding licensed HyperGro® fermentation technology

  • High yielding, high purity proprietary one-chromatography-step purification technology

  • Drug Master File (DMF) in place with US FDA for easy CMC dossier submission

  • Manufacturing in FDA inspected facility, inspected 2011, 2013, 2014

  • Experience manufacturing for Phase I, II and III clinical trials

  • Batch sizes up to 150 g at current scale and plans for kg scale manufacturing

Request a quote

See our press release Eurogentec Completes Manufacture of 150 g of GMP Plasmid DNA for Major Pharmaceutical Company.

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