PATfix® pDNA Platform

Increasing recovery and purity during downstream processing of pDNA is a vital step in meeting the surge in demand. Supporting rapid process development and optimization, PATfix^® pDNA analytical platform is providing reliable in-process control for pDNA production.

As the market for gene therapies continues to grow, the need for high quality plasmid (pDNA) is increasing. Many companies are looking to insource pDNA production and purification – usually as a key starting raw material for subsequent viral vector and mRNA production & purification.

PATfix^® pDNA analytical solution removes the need for analytical method develpment, saving valuable time. What once took months to optimize and years to perfect, can be achieved on far shorter timelines with the appropriate analytical tools. To help achieve such short development timelines, in-process analytics should have the capacity to:

• Easily analyse complex, pre-capture process samples
• Separation before quantification – leads to accurate mass balance determination

Supporting rapid process development and optimization, PATfix^® pDNA analytical platform provides reliable in-process control for pDNA process development and production. PATfix^® pDNA analytical platform package is designed to give “at-line” reliable insight during Process Development (PD) and production of pDNA. Besides the obvious hardware components, optimized based on our decades of experience with gene therapy analytics, the platform also includes the following features:

• Customized method development and validation of your sample
• Server-client based approach – 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