Gmp Grade Plasmid Dna

Descriptif

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.

Recherche scientifique - instituts et laboratoires
  • Plasmid Dna
  • Dna Production
  • European Pharmacopea
  • Gmp Process
  • Visual Inspection
  • Residual Rna
  • Dna Topology

Caractéristiques du produit

Safety tests Endotoxins, Bioburden/Sterility and Mycoplasma

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