Fast Tailor-Made At-Line Analytical Chromatography Solution

PATfix platforms are the key drivers of your process development and relied upon to provide in-process control during pDNA/mRNA production. Only basic chromo skills are required to start using this analytical tool, while offering the flexibility to grow with your expanding needs.

 

This page covers:

  1. PATfix pDNA Platform
  2. PATfix mRNA platform
  3. Software Demo
PATfix-Analytics

PATfix pDNA Platform

Global demand for pDNA production is at an all time high, due to increased need from Gene Therapy ramp-up. pDNA, as an enabling product, is critical in production of mRNA, AAV and other therapeutic vectors. Increasing yield and purity in the production of pDNA is a vital step in meeting such demand.

Supporting rapid process development and optimization, PATfix pDNA analytical platform is providing 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 following features:

Additional benefits

  • 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
patfix-pdna-key-features

Using a single system and method you can now quantify pDNA isoforms along the entire downstream processing workflow, while making sure impurities are removed.

PATfix-pDNA

PATfix mRNA Platform

Rapid PATfix analytical methods, underpinning advanced control strategies, can provide critical support for mRNA vaccine and therapeutics production. Real-time monitoring of mRNA production along with various steps of the process purification can facilitate timely process decisions. Chromatographic methods for achieving reproducible analytical separation of large biomolecules, especially for complex IVT mixtures, are being continuously improved. Recent mRNA analysis methodologies are embedded in a ready-to-use PATfix mRNA analytical platform.

The PATfix mRNA analytical platform is designed to enable reliable at-line insight during process development (PD) and production of mRNA, with emphasis on IVT reaction components (nucleotides and capping reagents) and final product quality control. By embedding thoroughly validated mRNA methods, the PATfix mRNA platform enables biotech professionals to accelerate development of their mRNA applications.

PATfix-mRNA_platform

The PATfix mRNA Analytical Platform Includes

  • Three distinct analytical approaches:
    • Robust methods for at-line IVT reaction monitoring
    • Fast and reliable methods for mRNA quantification
    • Quality control for mRNA size, integrity, and detection of dsRNA
  • PATfix – model-LPG
  • PATfix software, including mRNA platform
  • mRNA standard for 30 calibrations
  • 5 free CIMac analytical columns for mRNA platform

Additional benefits

  • Quantification of nucleotides and capping reagents
  • 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
  • Sensitive detector suite for low sample consumption

PATfix Software Demo

Our platforms are also supported with control & collect web application software that allows multiple users remote access, post-analysis chromatography data evaluation and calculations in a secured network environment.

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

Software Demo

Testimonial

 

“I was introduced to the PATfix analytical platform at the BASE Facility for the analysis of plasmid DNA and mRNA. The PATfix pDNA analytical platform package was helpful in getting the plasmid analysis running with validated protocols built-in the system. We have also been utilising PATfix for the analysis of IVT mRNA with validated protocols provided by Sartorius BIA Separations. We have been getting consistent and reliable results with high-throughput work processes made possible by the at-line implementation of the PATfix platform. I am happy with the system as it is easy to use, reliable and the support provided by the highly knowledgeable team at Sartorius BIA Separations and Sartorius has been excellent. I am looking forward to continuing working with the PATfix platform and the Sartorius BIA Separations team with their ongoing developments in providing high-quality analytical products.”

– Dae Jong Han, Research Specialist (Analytics), BASE Facility, Australia.

Base Facility, Australia
Teknova

“By leveraging the capabilities of PATfix, I can effectively determine the ratio of empty and full capsids in our samples, thus providing valuable insights into their purity values. The software’s integration functions are designed with user-friendliness in mind, making the analysis process seamless and efficient.”

– Tony Tavares, PhD | Principal Scientist. Teknova

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