PATfix® Model LPG

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PATfix® Model LPG
 

High performance HPLC solution designed for at-line analytics of gene therapy and vaccine products.

The PATfix® Model LPG analytical HPLC 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® HPLC 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

*Custom/bulk order quotes are provided within 72 hours of request.

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Genetic therapies provide new hope for vaccines and 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 empty from full AAV capsids. Backed by in-house expertise and extensive applications data, and combined with the CIMac® column, PATfix® Model LPG delivers analysis and in-process control for new generation gene therapies, vaccines and a wide range of other biomolecules.

Use the PATfix® Model LPG system for:

  • AAV: E | F AAV capsid separation and characterization in complex matrices
  • AAV: Total AAV characterization on clarifies harvest and tracking of AAV capsid purificationm
  • RNA: monitoring complex IVT reaction mixtures

  • Lentivirus: in process development, e.g. to select the optimal TFF membrane

  • Adenovirus – quantification with excellent range, LOD and LOQInfluenza A – quantification wit < 5 minute run times

PATfix® Model LPG in brief:

Fast, high-resolution HPLC analytics for large biomolecule applications

  • save time, cost and labor versus other established methods
  • accelerate process development and optimization
  • secure production runs with at-line feedback

Designed for purpose

  • accurate and reproducible control of complex gradients via conductivity | pH monitor
  • bio-buffer and CIP-resistant contact materials
  • low dead-volume and minized path lengths support high resolution

Unique CIMac® monolithic columns for “fingerprint” characterization, separation and quantification

  • available in 19 chemistries
  • simple sample prep, low sample consumption
  • easy transfer of analytical insights to preparative chromatography steps simplifies scale-up

CFR Part 11 compliant PATfix® software provides easy data processing, visualization, presentation and sharing

  • Access your data securely from anywhere with server-client based approach
  • Single database of chromatograms from multiple runs and multiple systems
  • Easily share interactive results with colleagues, customers and/or regulators

PATfix® Model LPG System Components

  • Quaternary Low Pressure Gradient pump with 10 mL ceramic pump head, degasser and mixer (250 µL)
  • Eluent tray
  • MWD multi wavelength detector, 190 - 700 nm, 8 channel, uv Flow cell: 10 mm, 10 µL
  • Autosampler, coolable, vials or microtiter plates
  • Conductivity | pH monitor
  • Chromatography data system, single instrument license (ClarityChrom chromatography software for instrument control and data acquisition)
  • PATfix® software for data processing, visualization and sharing
  • Set of 5 CIMac® columns per customers choice

Optional components include a column thermostat and a fluorescence detector.

  • Column Thermostat CT 2.1
    Column Thermostat CT 2.1
    Item no.
    PAT0030

    Heating and cooling System.

  • Basic Fluorescence Detector for Liquid Chromatography
    Basic Fluorescence Detector for Liquid Chromatography
    Item no.
    PAT0023

    The HPLC fluorescence detector is known for high sensitivity and specificity over other types of HPLC detectors.

  • CIMac™ AAV full/empty 0.1 mL Analytical Column (1.3 µm)
    CIMac™ AAV full/empty 0.1 mL Analytical Column (1.3 µm)
    Item no.
    110.8503-1.3

    CIMac™ Analytical Columns combine all elaborate characteristics of CIM monoliths at analytical scale and are your perfect tool for analysis and control of manufacturing processes, ideal for process analytical technology (PAT). Designed for fast and reproducible HPLC monitoring and quantitation of proteins, viruses, pDNA, and other large biomolecules, they allow you to achieve rapid, high-resolution and flow-independent separations in a matter of minutes.

  • CIMac™ EDA 0.1 mL Analytical Column (2 µm)
    CIMac™ EDA 0.1 mL Analytical Column (2 µm)
    Item no.
    110.5116-2

    CIMac™ Analytical Columns combine all elaborate characteristics of CIM monoliths at analytical scale and are your perfect tool for analysis and control of manufacturing processes, ideal for process analytical technology (PAT). Designed for fast and reproducible HPLC monitoring and quantitation of proteins, viruses, pDNA, and other large biomolecules, they allow you to achieve rapid, high-resolution and flow-independent separations in a matter of minutes.

  • CIMac™ Adeno 0.1 mL Analytical Column (2 µm)
    CIMac™ Adeno 0.1 mL Analytical Column (2 µm)
    Item no.
    110.8502-2

    CIMac™ Analytical Columns combine all elaborate characteristics of CIM monoliths at analytical scale and are your perfect tool for analysis and control of manufacturing processes, ideal for process analytical technology (PAT). Designed for fast and reproducible HPLC monitoring and quantitation of proteins, viruses, pDNA, and other large biomolecules, they allow you to achieve rapid, high-resolution and flow-independent separations in a matter of minutes.

  • CIMac™ DEAE 0.1 mL Analytical Column (1.3 µm)
    CIMac™ DEAE 0.1 mL Analytical Column (1.3 µm)
    Item no.
    110.5114-1.3

    CIMac™ Analytical Columns combine all elaborate characteristics of CIM monoliths at analytical scale and are your perfect tool for analysis and control of manufacturing processes, ideal for process analytical technology (PAT). Designed for fast and reproducible HPLC monitoring and quantitation of proteins, viruses, pDNA, and other large biomolecules, they allow you to achieve rapid, high-resolution and flow-independent separations in a matter of minutes.

  • CIMac™ SO3 0.1 mL Analytical Column (1.3 µm)
    CIMac™ SO3 0.1 mL Analytical Column (1.3 µm)
    Item no.
    110.6157-1.3

    CIMac™ Analytical Columns combine all elaborate characteristics of CIM monoliths at analytical scale and are your perfect tool for analysis and control of manufacturing processes, ideal for process analytical technology (PAT). Designed for fast and reproducible HPLC monitoring and quantitation of proteins, viruses, pDNA, and other large biomolecules, they allow you to achieve rapid, high-resolution and flow-independent separations in a matter of minutes.

  • CIMac™ QA 0.1 mL Analytical Column (1.3 µm)
    CIMac™ QA 0.1 mL Analytical Column (1.3 µm)
    Item no.
    110.5113-1.3

    CIMac™ Analytical Columns combine all elaborate characteristics of CIM monoliths at analytical scale and are your perfect tool for analysis and control of manufacturing processes, ideal for process analytical technology (PAT). Designed for fast and reproducible HPLC monitoring and quantitation of proteins, viruses, pDNA, and other large biomolecules, they allow you to achieve rapid, high-resolution and flow-independent separations in a matter of minutes.

  • CIMac™ r-Protein A 0.1 mL Analytical Column (2 µm)
    CIMac™ r-Protein A 0.1 mL Analytical Column (2 µm)
    Item no.
    110.1004-2

    CIMac™ Analytical Columns combine all elaborate characteristics of CIM monoliths at analytical scale and are your perfect tool for analysis and control of manufacturing processes, ideal for process analytical technology (PAT). Designed for fast and reproducible HPLC monitoring and quantitation of proteins, viruses, pDNA, and other large biomolecules, they allow you to achieve rapid, high-resolution and flow-independent separations in a matter of minutes.

  • CIMac™ EDA 0.1 mL Analytical Column (1.3 µm)
    CIMac™ EDA 0.1 mL Analytical Column (1.3 µm)
    Item no.
    110.5116-1.3

    CIMac™ Analytical Columns combine all elaborate characteristics of CIM monoliths at analytical scale and are your perfect tool for analysis and control of manufacturing processes, ideal for process analytical technology (PAT). Designed for fast and reproducible HPLC monitoring and quantitation of proteins, viruses, pDNA, and other large biomolecules, they allow you to achieve rapid, high-resolution and flow-independent separations in a matter of minutes.

  • CIMac™ QA 0.1 mL Analytical Column (6 µm)
    CIMac™ QA 0.1 mL Analytical Column (6 µm)
    Item no.
    110.5113-6

    CIMac™ Analytical Columns combine all elaborate characteristics of CIM monoliths at analytical scale and are your perfect tool for analysis and control of manufacturing processes, ideal for process analytical technology (PAT). Designed for fast and reproducible HPLC monitoring and quantitation of proteins, viruses, pDNA, and other large biomolecules, they allow you to achieve rapid, high-resolution and flow-independent separations in a matter of minutes.