PATfix® mRNA Platform

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Rapid at-line analytical chromatography solution for all stages of mRNA production, purification and quality assesment. Gain immediate feedback on purities and recoveries during process development.

PATfix® mRNA platform is the all-in-one solution when it comes to a wide array of mRNA analytics. It contains all the necessary hardware, software, columns, standard, methods and user guides/SOPs to enable analytical insights from day one. The analytical methods have been developed according to FDA & EMA guidelines.

Item No.: 
PAT0050

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

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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.

The platform is supported with control & collect web application software that allows multiple users a remote access and post-analysis chromatography data evaluation and calculations in a secured network environment.

PATfix® software is built with modern concepts and users in mind. Besides controlling the system and enabling advanced data analysis, users can easily access both the system and data from the comfort of the office or a WFH setting – cutting down on spending unnecessary time in the lab.

PATfix

®

mRNA 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® analytical quaternary system
  • PATfix® software, including mRNA platform
  • mRNA standard for 30 x calibrations
  • 5x Included 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® MALS detector
    PATfix® MALS detector
    Item no.
    PAT0033

    The perfect detector when your drug substance is a particle.

  • PATfix® pDNA Platform
    PATfix® pDNA Platform
    Item no.
    PAT0029

    Rapid at-line analytical chromatography solution for all stages of pDNA processing.

    PATfix® pDNA is a biocompatible HPLC-based platform, engineered for pDNA isoform and multimer separation. Built around analytical capability of the CIMac® pDNA monolithic columns, the pDNA platform includes user guides, validated methods, SOPs and pDNA standards and user-friendly PATfix® software.

  • Fluorescence Detector
    Fluorescence Detector
    Item no.
    PAT0023

    The perfect detector for analysis of complex samples via fluorescence selectivity

  • 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™ 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™ SDVB 0.1 mL Analytical Column (2 µm)
    CIMac™ SDVB 0.1 mL Analytical Column (2 µm)
    Item no.
    BIA-110.9001-2

    Strongly hydrophobic styrene divinylbenzene is a versatile reversed phase chromatography ligand enabling high throughput and high-resolution analytics.

  • 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.