Catalog no. PAT0029

PATfix pDNA Platform is designed for in-process control of plasmid DNA production at all process stages, from process development to production. It gives reliable insights into:

  • Separation of pDNA isoforms and multimers
  • Detection of impurities (RNA, endotoxin, gDNA, proteins)
  • Quantification and purity analysis of pDNA species

PATfix pDNA Platform includes everything you need for pDNA monitoring:

  • Hardware: a biochromatography system with selected components
  • Software: a dedicated PATfix pDNA framework
  • Analytical columns: specialized for pDNA in-process monitoring
  • Methods: validated analytical methods for pDNA monitoring and SOPs

Application | Methods

The PATfix® pDNA platform provides valuable analytical insights at all stages of pDNA processing, from upstream production through downstream purification and from process development to production of materials for clinical or commercial applications. At-line analytics support informed, accelerated process development and secure production runs and product quality.

Optimized analytical methods are a key component of a  well-functioning analytical system. The PATfix® pDNA analytics platform includes fully optimized and validated analytical methods, as well as guidelines for buffer and sample preparation, including detailed SOPs. In addition, the PATfix® pDNA analytical package includes a pDNA calibration standard, which enables accurate quantification of the pDNA species of interest as well as batch-to-batch and day-to-day performance tracking. Additional in-process robustness is guaranteed by the conductivity and pH monitors, that ensure the analysis is being performed with correct buffers and gradients.

Quantification

The chromatogram shows different concentrations of pDNA standard 1, 5, 10, 20, 50 μg/mL

Additional benefits

  • Customized method development and validation of your sample through Cornerstone services
  • Server-client based software design – access your data securely from anywhere (office, home) 
  • Easily share interactive results with colleagues, customers and/or regulators
  • Report generation helps ease the paperwork load
  • Part 11 compliance allows easy implementation of PATfix analytics in FDA approval process
  • Appropriate for analysis of both small and big plasmids
  • Sensitive detector suite for low sample consumption

Try out the PATfix software demo, follow the link below.

Software Demo

Library

All Library Resources