PATfix® Solutions
The PATfix® 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.
*Custom/bulk order quotes are provided within 72 hours of request.
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Products (7)
The perfect detector when your drug substance is a particle.
When additional sample characterization is required, the fraction collector allows for easy automation of sample collection, that can then be analysed offline in-depth.
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.
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.
Temperature control system with heating and cooling
The perfect detector for analysis of complex samples via fluorescence selectivity
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 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.
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.
Application Notes
Datasheet
Poster
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.