PATfix® Solutions

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PATfix® Solutions PATfix® Solutions PATfix® Solutions PATfix® Solutions PATfix® Solutions PATfix® Solutions PATfix® Solutions PATfix® Solutions
 

The PATfix® system provides modality-appropriate analysis and in-process control for gene therapy and vaccine products. Designed to take full advantage of the capabilities of CIMac™ analytical monolithic columns, the PATfix® delivers fast, high-resolution runs. Operation with multiple detector types provides content- rich analyses even with complex samples. User friendly PATfix® software makes for easy data processing, visualization and sharing.

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PATfix® Solutions
PATfix® Solutions

The PATfix® system provides modality-appropriate analysis and in-process control for gene therapy and vaccine products. Designed to take full advantage of the capabilities of CIMac™ analytical monolithic columns, the PATfix® delivers fast, high-resolution runs. Operation with multiple detector types provides content- rich analyses even with complex samples. User friendly PATfix® software makes for easy data processing, visualization and sharing.

Item No.:
M_PATfix

Overview

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Products (17)

  • Column Thermostat
    Documents
    Column Thermostat
    Temperature control system with heating and cooling
    Item no.
    PAT0030
    Price
    Item no.
    PAT0030
  • Fluorescence Detector
    Documents
    Fluorescence Detector
    The perfect detector for analysis of complex samples via fluorescence selectivity
    Item no.
    PAT0023
    Price
    Item no.
    PAT0023
  • PATfix® analytical quaternary system
    Documents
    PATfix® analytical quaternary system
    Biocompatible analytical chromatography system with quaternary buffer setup.
    PATfix® analytical quaternary system is an at-line tool, to help process developers of novel gene therapies get immediate feedback on their current process state. This enables faster iteration and process optimization towards better purities and higher recoveries. The Sartorius analytical system provides modality-appropriate analysis and in-process control for gene therapy and vaccine products. Designed to take full advantage of the capabilities of CIMac™ analytical monolithic columns, the PATfix® delivers fast, high-resolution runs. Operation with multiple detector types provides content- rich analyses even with complex samples. User friendly PATfix® software makes for easy data processing, visualization and sharing.
    Item no.
    PAT0021
    Price
    Item no.
    PAT0021
  • Fraction Collector
    Documents
    Fraction Collector
    When additional sample characterization is required, the fraction collector allows for easy automation of sample collection, that can then be analysed offline in-depth.
    Item no.
    PAT0031
    Price
    Item no.
    PAT0031
  • PATfix® MALS detector
    Documents
    PATfix® MALS detector
    The perfect detector when your drug substance is a particle.
    Item no.
    PAT0033
    Price
    Item no.
    PAT0033
  • PC, Windows 10 Professional, Monitor
    PC, Windows 10 Professional, Monitor
    The PATfix® system provides modality-appropriate analysis and in-process control for gene therapy and vaccine products. Designed to take full advantage of the capabilities of CIMac™ analytical monolithic columns, the PATfix® delivers fast, high-resolution runs. Operation with multiple detector types provides content- rich analyses even with complex samples. User friendly PATfix® software makes for easy data processing, visualization and sharing.
    Item no.
    PAT0006
    Price
    Item no.
    PAT0006
  • OPTIONAL: 10 mm Flow cell
    OPTIONAL: 10 mm Flow cell
    The PATfix® system provides modality-appropriate analysis and in-process control for gene therapy and vaccine products. Designed to take full advantage of the capabilities of CIMac™ analytical monolithic columns, the PATfix® delivers fast, high-resolution runs. Operation with multiple detector types provides content- rich analyses even with complex samples. User friendly PATfix® software makes for easy data processing, visualization and sharing.
    Item no.
    PAT0024
    Price
    Item no.
    PAT0024
  • PATfix® - AAV Switcher Platform
    PATfix® - AAV Switcher Platform
    The PATfix® AAV Switcher Platform is a chromatography-based analytical platform that simplifies AAV quality monitoring with a 2-step process – capture and separation – to accurately measure viral quality from the complex upstream samples.
    Item no.
    PAT0140
    Price
    Item no.
    PAT0140
  • PATfix® - LNP Switcher Platform
    Documents
    PATfix® - LNP Switcher Platform
    PATfix® LNP Switcher is a chromatography-based analytical platform tailored for lipid nanoparticle (LNP) characterization, enabling at-line determination of encapsulation efficiency, particle size, and lipid composition to accelerate nucleic acid–based therapeutic development.


    Item no.
    PAT0120
    Price
    Item no.
    PAT0120
  • PATfix® - pDNA Platform
    Documents
    PATfix® - pDNA Platform
    PATfix® pDNA Platform: A chromatography-based analytical solution tailored for plasmid DNA (pDNA) processing, enabling rapid at-line isoforms (open circular, supercoiled, linear) and multimer separation, quantification, and process control across all stages.
    Item no.
    PAT0100
    Price
    Item no.
    PAT0100

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  • PATfix® - mRNA Platform
    Documents
    PATfix® - mRNA Platform
    PATfix® mRNA Platform: A chromatography-based analytical platform tailored for mRNA characterization, enabling at-line IVT reaction monitoring, rapid quantification, and comprehensive quality control (size, integrity, dsRNA) to accelerate nucleic acid therapeutic development.
    Item no.
    PAT0110
    Price
    Item no.
    PAT0110
  • PATfix® - AAV Platform
    Documents
    PATfix® - AAV Platform
    • PATfix®
    Item no.
    PAT0130
    Price
    Item no.
    PAT0130
  • OPTIONAL: Flow cell: 50 mm
    OPTIONAL: Flow cell: 50 mm
    The PATfix® system provides modality-appropriate analysis and in-process control for gene therapy and vaccine products. Designed to take full advantage of the capabilities of CIMac™ analytical monolithic columns, the PATfix® delivers fast, high-resolution runs. Operation with multiple detector types provides content- rich analyses even with complex samples. User friendly PATfix® software makes for easy data processing, visualization and sharing.
    Item no.
    PAT0020
    Price
    Item no.
    PAT0020
  • PATfix™ - model-Hybrid (analytical/semi-prep)
    PATfix™ - model-Hybrid (analytical/semi-prep)
    The PATfix® system provides modality-appropriate analysis and in-process control for gene therapy and vaccine products. Designed to take full advantage of the capabilities of CIMac™ analytical monolithic columns, the PATfix® delivers fast, high-resolution runs. Operation with multiple detector types provides content- rich analyses even with complex samples. User friendly PATfix® software makes for easy data processing, visualization and sharing.
    Item no.
    PAT0028
    Price
    Item no.
    PAT0028
  • pDNA standard pFix15 sc/oc (250 µg)
    pDNA standard pFix15 sc/oc (250 µg)
    Plasmid pFix15 standard is a 15.4 kb plasmid DNA isolated from E. coli and chromatographically purified. It is mainly intended for System Suitability Testing and preparation of a standard curve.
    Item no.
    BIA-PFIX15.1.1
    Price
    Item no.
    BIA-PFIX15.1.1

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Genetic therapies are providing new hope for vaccines as well as previously incurable diseases, but they also present new challenges for process development and control. The sheer size and complexity of products like pDNA, mRNA and AAV present a new challenge for "at-line" analytics, like distinguishing sc/oc/lin pDNA or empty from full AAV capsids.

At Sartorius BIA Separations, we are passionate about providing the best solutions for gene therapy purification, by providing a modality-specific platform for analysis and in-process control of new generation gene therapy products.

To achieve this, we have built our platform on 4 key pillars:

Software

Process development and production of gene therapy products brings together people with different skills and specializations, hence PATfix® software is built to address the needs and solve challenges of each. An integral part of the PATfix® value proposition, the PATfix® software strips away the complexity of chromatography at the day-to-day operational level, while retaining it for higher level tasks.

CIMac™ columns

CIMac™ analytical columns, are a perfect tool for chromatography of large gene therapy products due to convective laminar flow, a large accessible surface area required for product binding and a variety of surface chemistries. These characteristics give us the versatility to customize the PATfix® plattform for a broad range of gene therapy products.

Hardware

Featuring bio-inert ceramic pump heads, and flow rates up to 10 mL/min (quaternary pump), PATfix® is designed to extract maximum analytical information for a wide range of biological products. A highly sensitive, multi-wavelength UV detector, as well as a fluorescence detector, capture component peaks, even with the steepest gradients.

Know-how

It's not just about the individual building blocks, it's knowing exactly which blocks are required and how they need to work together to achieve their stated goal – provide analytical insight at every step of gene therapy process development and production. Gaining this level of insight requires a lot of trial and error to perfect. We have developed and transferred methods for both analytics and production of gene therapeutics to many customers. The experience gained on such a variety of products and projects has allowed us to develop a set of chromatographic methods, that can encompass a variety of products and can be applied to key steps of PD and production.