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PATfix platforms

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.

PATfix™ mRNA platform

Rapid HPLC 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.

PATfix mRNA 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 includes:

PATfix mRNA platform benefits

  • 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 x calibrations
  • 5x FREE CIMac™ 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™ 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.

Introducing PATfix™ pDNA

An analytical HPLC platform package 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:

Key Features

Key features PATfix pDNA

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

pDNA processing steps graphs

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

Additional assets

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.

TRY IT

To get a better feeling for how the PATfix™ platform would enhance your work environment, have a look at the explainer video.

Order your PATfix platform today.

For technical assistance please contact PATfix.help@biaseparations.com

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