PATfix® analytical quaternary system

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PATfix® analytical quaternary system PATfix® analytical quaternary system PATfix® analytical quaternary system PATfix® analytical quaternary system PATfix® analytical quaternary system 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
Availability: 

*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 LOQ
  • Influenza A – quantification with < 5 minute run times

PATfix® Model LPG in brief:

Fast, high-resolution analytical chromatography 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
    Column Thermostat
    Item no.
    PAT0030

    Temperature control system with heating and cooling

  • Fluorescence Detector
    Fluorescence Detector
    Item no.
    PAT0023

    The perfect detector for analysis of complex samples via fluorescence selectivity

  • 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™ AAV Analytical Columns are intended for fast and reproducible analysis and quantification in Adeno-associated virus (AAV) processes.

    With a resolution high enough to resolve empty and full virus capsids and high volumetric flow ratesm they provide information about the product quantity and purity within 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™ Adeno Analytical Columns are intended for fast and reproducible analysis and quantification of Adenovirus samples at different stages of downstream and upstream.

  • 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™ Adeno Analytical Columns are intended for fast and reproducible analysis and quantification of Adenovirus samples at different stages of downstream and upstream.

  • 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

    This high-performance ion-exchange column is primarily intended for fast, efficient and reproducible analysis and in-process control of samples throughout different purification steps.

  • 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

    This high-performance analytical column is primarily intended for fast, efficient and reproducible analysis and in-process control of proteins, viral particles and other biomolecules under hydrophilic conditions throughout different purification steps.

  • 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™ r-Protein Analytical Columns are primarily intended for fast, efficient, and reproducible analysis of immunoglobulin G (IgG).

  • 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

    This high-performance ion-exchange column is primarily intended for fast, efficient and reproducible analysis and in-process control of samples throughout different purification steps.

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

    This high-performance ion-exchange column is primarily intended for fast, efficient and reproducible analysis and in-process control of samples throughout different purification steps.

  • CIMac™ Oligo dT18 0.1 mL Analytical Column (C12 Linker) (2 µm)
    CIMac™ Oligo dT18 0.1 mL Analytical Column (C12 Linker) (2 µm)
    Item no.
    110.1219-2

    CIMac™ Oligo dT18 analytical columns are primarily intended for fast and efficient analysis of messenger RNA with a polyadenylated tail from various sources.

  • CIMac™ Oligo dT18 0.1 mL Analytical Column (C6 Linker) (2 µm)
    CIMac™ Oligo dT18 0.1 mL Analytical Column (C6 Linker) (2 µm)
    Item no.
    110.1218-2

    CIMac™ Oligo dT18 analytical columns are primarily intended for fast and efficient analysis of messenger RNA with a polyadenylated tail from various sources.

  • CIMac™ OH 0.1 mL Analytical Column (1.3 µm)
    CIMac™ OH 0.1 mL Analytical Column (1.3 µm)
    Item no.
    110.8140-1.3

    This high-performance analytical column is primarily intended for fast, efficient and reproducible analysis and in-process control of proteins, viral particles and other biomolecules under hydrophilic conditions throughout different purification steps.

  • CIMac PrimaS® 0.1 mL Analytical Column (2 µm)
    CIMac PrimaS® 0.1 mL Analytical Column (2 µm)
    Item no.
    110.5118-2

    CIMac PrimaS® is a key player within BIA’s family of high-performance chromatography products for analysis and purification of mRNA.

  • CIMac™ r-Protein G 0.1 mL Analytical Column (1.3 µm)
    CIMac™ r-Protein G 0.1 mL Analytical Column (1.3 µm)
    Item no.
    110.1011-1.3

    CIMac™ r-Protein Analytical Columns are primarily intended for fast, efficient, and reproducible analysis of immunoglobulin G (IgG).

  • CIMac™ XY 0.1 mL Analytical Column (1.3 µm)
    CIMac™ XY 0.1 mL Analytical Column (1.3 µm)
    Item no.
    110.7175-1.3

    Epoxy monoliths are used for covalent immobilisation of peptides, proteins and enzymes containing a reactive nucleophilic group (e.g. amino, thiol, hydroxyl) on their surface.

  • CIMac™ CDI 0.1 mL Analytical Column (1.3 µm)
    CIMac™ CDI 0.1 mL Analytical Column (1.3 µm)
    Item no.
    110.8000-1.3

    Carboxyimidazole (CDI) monolithic chromatographic columns are used for covalent immobilisation of ligands (e.g. proteins, peptides and other amine- or thiol-containing molecules).

  • CIMac™ SO3 0.1 mL Analytical Column (2 µm)
    CIMac™ SO3 0.1 mL Analytical Column (2 µm)
    Item no.
    110.6157-2

    This high-performance ion-exchange column is primarily intended for fast, efficient and reproducible analysis and in-process control of samples throughout different purification steps.

  • CIMac™ C4 HLD 0.1 mL Analytical Column (2 µm)
    CIMac™ C4 HLD 0.1 mL Analytical Column (2 µm)
    Item no.
    110.8136-2

    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™ OH 0.1 mL Analytical Column (2 µm)
    CIMac™ OH 0.1 mL Analytical Column (2 µm)
    Item no.
    110.8140-2

    This high-performance analytical column is primarily intended for fast, efficient and reproducible analysis and in-process control of proteins, viral particles and other biomolecules under hydrophilic conditions throughout different purification steps.

  • CIMac™ SO3 0.1 mL Analytical Column (6 µm)
    CIMac™ SO3 0.1 mL Analytical Column (6 µm)
    Item no.
    110.6157-6

    This high-performance ion-exchange column is primarily intended for fast, efficient and reproducible analysis and in-process control of samples throughout different purification steps.

  • CIMac™ HDZ 0.1 mL Analytical Column (1.3 µm)
    CIMac™ HDZ 0.1 mL Analytical Column (1.3 µm)
    Item no.
    110.8002-1.3

    Hydrazide activated monolithic columns are used to immobilise glycoproteins through oxidised sugar groups and other carbonyl containing molecules.

    Antibodies, in particular immunoglobulins G (IgG) containing abundant glycosylation, can be covalently bound to the matrix leaving unobstructed antigen binding sites.

  • CIMac™ OH 0.1 mL Analytical Column (6 µm)
    CIMac™ OH 0.1 mL Analytical Column (6 µm)
    Item no.
    110.8140-6

    This high-performance analytical column is primarily intended for fast, efficient and reproducible analysis and in-process control of proteins, viral particles and other biomolecules under hydrophilic conditions throughout different purification steps.