Plasmid DNA production

Delphi Genetics provides customized plasmid DNA production services, from milligram to gram scale, for your R&D and clinical activities.
We take care of your plasmid DNA material for viral vectors production, DNA vaccines and naked DNA-based gene therapy.

Our service includes the supply of:

  • R&D grade for non-clinical use, support for lead identification, clone screening, STABY evaluation, protein expression...
  • High Quality and GMP grade plasmid DNA for viral and non-viral (pre-)clinical activities

GMP Grade Plasmid DNA

GMP grade plasmid DNA production is based on robust, single-use, TSE-BSE-free methods and occurs in our GMP suite, at a maximum scale of 50L.

Delphi Genetics offers one-stop-shop CDMO service for plasmid DNA GMP supply, including:

  • GMP compliant Process and QC Development
  • GMP E.coli cell banking (Master and Working Cell Banks)
  • GMP DNA Manufacturing using TSE-BSE free and Single-use process, based on QP approved Master Batch Record
  • QC and Release by Qualified Person (QP)

Full Quality Control complying with the European pharmacopea 5.14 will be performed:

  • Content and purity by UV measurement (260/280 nm)
  • Visual inspection
  • Identity by restriction and DNA sequencing (full plasmid sequencing)
  • Safety tests: endotoxin and bioburden
  • Residual RNA content
  • Residual host protein
  • Residual host genomic by Q-QPCR
  • pH
  • Topology

Other tests can be performed on request.

QP Released GMP Plasmid DNA is provided with TSE-BSE-free certificate and Certificate of Analysis.

High-Quality Grade Plasmid DNA

High-Quality grade plasmid DNA production is based on robust, single-use, TSE-BSE-free methods and occurs in our GMP suite, at a maximum scale of 50L, after Delphi's process performance assessment.

Full Quality Control complying with the European pharmacopea 5.14 will be performed:

  • Content and purity by UV measurement (260/280 nm)
  • Visual inspection
  • Identity by restriction and DNA sequencing (full plasmid sequencing)
  • Safety tests: endotoxin and bioburden
  • Residual RNA content
  • Residual host protein
  • Residual host genomic by Q-QPCR
  • pH
  • Topology

Other tests can be performed on request.

High quality Plasmid DNA is provided with TSE-BSE-free certificate and Certificate of Analysis.

R&D Grade Plasmid DNA

R&D plasmid DNA will be produced in shake flask or in fermentor (from 5L to 50L), in our R&D facility, and purified by classical method.

R&D plasmids are provided Endotoxin-free.