From small scale to medium scale, for your R&D to your clinical batch, Delphi Genetics provides a customized plasmid DNA production services.
We deliver customers for their R&D project, viral vector production, DNA vaccines and naked DNA based gene therapy.
According to the quantity requested, your plasmid DNA will be produced in shake flask or in fermentor (from 5L to 50L).
All our plasmid DNA are provided endotoxin free.
R&D grade plasmid DNA is purified by classical method.
For High Quality grade plasmid DNA, we developed a strong and robust RNAse-free purification method.
The integration of our Staby® technology in your plasmid DNA will increase the robustness of the bioproduction process by a full stabilisation of your plasmid. By removing antibiotic resistance gene you will be in line with regulatory agencies recommandations for your gene therapy and recombinant viruses production.
Our High-Quality grade plasmid DNA production is based on a robust RNAse-free purification method.
After fermentation, cells are harvested and treated for alkalyne lysis. Plasmid DNA is collected and purified from genomic DNA and RNA using a 2 to 3 steps column. The plasmid DNA is then deliver in the buffer of your choice after a complete Quality Control analysis.
Our Quality Control is complying the pharmacopea E. Ph 5.14 and includes:
- Content concentration and purity by UV measurement (260/280 nm)
- Visual inspection
- Identity by restriction and DNA sequencing (full plasmid sequencing)
- Safety : endotoxin test and sterility test (bioburden)
- Residual RNA content by agarose gel electrophoresis and HPLC
- Residual host protein (BCA test or ELISA test)
- Residual host genomic (QPCR)
- DNA homogeneity: % of supercoiled DNA evaluated on agarose gel electrophoresis + HPLC
Other tests can be performed on request.