Description
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.
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 LOQ
Influenza A – quantification with < 5 minute run times
PATfix®Model LPG in brief:
Fast, high-resolution analytical chromatography 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
Designed for purpose
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
Unique 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
PATfix®Model LPG System Components
Quaternary Low Pressure Gradient pump with 10 mL ceramic pump head, degasser and mixer (250 µL)
Eluent tray
MWD multi wavelength detector, 190 - 700 nm, 8 channel, uv Flow cell: 10 mm, 10 µL
Autosampler, coolable, vials or microtiter plates
Conductivity | pH monitor
Chromatography data system, single instrument license (ClarityChrom chromatography software for instrument control and data acquisition)
PATfix®software for data processing, visualization and sharing
Set of 5 CIMac™ columns per customers choice
Optional components include a column thermostat and a fluorescence detector.
