GMP klasės plazmidinė DNR
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.
Safety tests:Endotoxins, Bioburden/Sterility and Mycoplasma