Productions - Import export

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: Endotoxins, Bioburden/Sterility and Mycoplasma 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.

Portée: • Evaluer toute action d’optimisation énergétique, de production d’énergie ou de recours aux énergies renouvelables • Analyser tous les facteurs de risques et définir les mesures préventives