Description
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 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
1x CIMac PrimaS 0.1 mL Analytical Column (2 µm channels)
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
