PATfix®
Featuring bio-inert ceramic pump heads and flow rates up to 10 mL per minute, PATfix® is designed to manage the analytical parameters for a wide range of biological products. A highly sensitive, multi-wavelength UV detector as well as a fluorescence detector, captures component peaks, even with the steepest gradients.
PATfix® is powered by PATfix® software, a comprehensive, user-friendly toolbox for automated analysis of chromatographic data sets. PATfix® software provides rapid feedback to help you make critical process control decisions.
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Products (2)
Rapid at-line analytical chromatography solution for all stages of pDNA processing.
PATfix® pDNA is a high-performance HPLC system, engineered for pDNA isoform and multimer separation using the unique analytical capability of the CIMac® pDNA monolithic column. User guides, validated methods, SOPs and pDNA standards are included. User friendly PATfix® software makes for easy data processing, visualization and sharing.
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.
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 in turn allow us to tailor the PATfix platform for best results irrespective of gene therapy product.
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
Its not just about the individual building blocks, its 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.