PATfix® HPLC System - Sartorius Croatia

PATfix® HPLC System

PATfix® HPLC system is a 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. User friendly PATfix® software makes for easy data processing, visualization and sharing.
Price: On request

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.

What is the PATfix® HPLC system used 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

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

Unique design

  • 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

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

Application Note: Comparison of HIC Monolithic Support for Sample Displacement Chromatography of pDNA
Application Note: In-Process Control of pDNA Production on CIMac™ pDNA Analytical Column
Datasheet: CIMac Analytical Columns - Monolithic Columns for Large Biomolecule HPLC Analytics
Poster: Combining the Sensitivity of the PATfix® HPLC Platform With Ultracentrifugation for AAV Characterization
Poster: Fast HPLC Analytics for IVT Reaction Characterization and Tracking Using CIMac PrimaS™ and PATfix®
Poster: Estimation of Empty | Full AAV10 Particle Ratio Using MALS Detector