Specializing in cGMP Plasmid Manufacturing
VGXI’s highly skilled Quality Control Team can support all standard testing applicable to plasmid DNA products and E. coli master cell banks. All tests offered are validated or performed per USP guidelines.
Recommended Testing for Plasmid Master Cell Banks
- Host Identification
- Identification of E. coli K12 strain
- Culture Purity
- Detection of Bacteriophage
- Cell Viability
- Plasmid Retention
- Plasmid Identification by DNA Sequencing
Recommended Testing for Plasmid Products
- Nucleic Acid Concentration
- Purity by A260/280
- Identity by AGE
- Analysis of Total Supercoil Forms by HPLC
- Analysis of Total Circular Forms by HPLC
- Host-Cell RNA
- Host-Cell Protein
- Host-Cell DNA
- Endotoxin
- pH
- Appearance
- Bioburden or Sterility
In addition to the recommended testing above, additional testing is available per client request. Contact us for more information.
