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 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)
Residual host RNA
Residual host RNA analysis using Agarose gel electrophoresis
Residual protein
Testing amount of total protein using Bicinchoninic acid assay (BCA)
Residual kanamycin
Testing residual Kanamycin antibiotics in plasmid product using colorimetric method
Technical Information
When a gene therapy company needed to verify plasmid identity, purity, and integrity for an IND submission, Avance Biosciences delivered a validated NGS-based solution. The assay enabled low-level variant detection and trace contaminant analysis, supporting FDA compliance and lot release.
