CGMP Plasmid DNA Release Testing
Plasmid DNA testing is essential for verifying the identity, purity, concentration, and safety of plasmid preparations. These tests are crucial for ensuring that plasmid-based products perform as intended and comply with regulatory requirements. By choosing Avance Biosciences, you can be confident that your plasmid DNA products are thoroughly tested, minimizing risks, and enhancing product reliability.
CGMP Plasmid Testing Services
Critical Quality Attributes
Assay
Description
Identity
Plasmid Sequence Confirmation
Sanger sequencing of plasmid insert or part of plasmid for identity
Restriction map
Fragment analysis of digested plasmid by agarose gelelectrophoresis
Concentration
Plasmid concentration (A260)
Plasmid concentration measured by ultraviolet spectroscopy (UV) at 260 nm
Plasmid purity (A260/280)
Evaluate purity of plasmid by A260/A280 ratio using ultraviolet spectroscopy (UV)
Purity
Plasmid purity (A260/280)
Evaluate purity of plasmid by A260/A280 ratio using ultraviolet spectroscopy (UV)
Plasmid topology % Supercoiled
Plasmid Topology analysis by Capillary electrophoresis (CE)
Residual host RNA
Residual host RNA analysis using Agarose gel electrophoresis
Purity
Residual host DNA
Quantitation of residual host cell DNA in test sample by QPCR
Residual host DNA
Quantitation of residual host cell DNA in test sample by QPCR
Residual protein
Testing amount of total protein using Bicinchoninic acid assay (BCA)
Host cell protein
Testing residual amount of E coli protein by ELISA
Residual kanamycin
Testing residual Kanamycin antibiotics in plasmid product using colorimetric method
Safety
Bioburden
USP <61>
Endotoxin
USP <85>
Safety
Bioburden
USP <61>
Sterility
USP <71>
Other
Appearance
USP <790>
pH
USP <791>