Accelerate early research, development, & release testing of GTx drug substances and products
With size exclusion chromatography (SEC), analysts can quickly assess the aggregate content, integrity, heterogeneity, and purity of gene therapy drug substances. Waters GTxResolve SEC Columns incorporate breakthrough chemistry technologies for the fast analysis of large biological analytes and a number of first-of-their-kind multi-attribute quantitation assays.
Achieve new benchmarks in quality with high resolution, low adsorption, and robust GTxResolve SEC Columns for lipid nanoparticles (LNPs), nucleic acids, and viral vector analyses that:
- Accelerate aggregate and size variant analysis with high resolution that enables detection of low-level impurities
- Deliver reproducible data necessary for platform methods
- Improve cost savings with columns that maintain a long shelf life
- Achieve low secondary interaction enabling low MALS noise
- Provide low adsorption hardware necessary with biologics to enhance recovery
- Support different drug development stages with cost-effective, reproducible, and robust SEC platform methods
- Obtain higher resolution essential for size variant analysis and the detection of low-level impurities
- Achieve sufficient recovery with low adsorption hardware and inert packing materials that reduce the need for large volume sample injections
- Gain valuable multi-attribute measurements on size-distribution, molar mass, aggregate conformations, and absolute titer when combined with universally applied detectors such as multi-angle light scattering detectors (MALS)
- Achieve lower secondary interactions to support the development of platform methods with novel packing material and surface chemistry
- Recommended Use: For analysing aggregate/size variants of gene therapy drug substances and products.
