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Rapid HPLC 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.
Introducing PATfix mRNA analytical platform
The PATfix™ mRNA analytical platform is a new member of our PATfix™ platforms family, 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.
PATfix™ mRNA platform includes:
The platform is also supported with control & collect web application software that allows multiple users remote access, post-analysis chromatography data evaluation and calculations in a secured network environment.
Discover additional benefits
New Application Note: PATfix™ mRNA analytical platform for final product characterization and quantification
Robust and precise chromatographic analytical methods are key for efficient development of mRNA production process. Three different analytical methods, which utilize three different column chemistries, are embedded in a ready-to-use PATfix™ mRNA analytical platform to support mRNA process development and product quantification and characterization. Click here to discover all the possibilities they bring.
New Publication: Increasing Dynamic Binding Capacity of Oligo(dT) for mRNA Purification: Experimental Results Using CIM 96-Well Plates
Affinity-based chromatographic isolation of mRNA is robust and simple, lending itself as a useful industrial platform. mRNA constructs typically contain a 3’ polyA tail to increase stability in vivo, thereby enabling affinity purification using Oligo dT probes covalently coupled to a solid support. Typical binding capacity for CIMmultus™ Oligo dT for mRNA is 2-4 mg/mL, depending on construct length and loading concentration of NaCl. Due to an increasing productivity of IVT reaction protocols, which routinely reach 5-10 mg/mL, elucidation of conditions that increase binding capacity of Oligo dT has been an intense focus of development.
CIM® Oligo dT 0.05 mL Monolithic 96-well Plates were used for multi-parallel screening of binding conditions. Binding capacity could be significantly increased if NaCl is replaced with Gu-HCl, with DBC values of >6 mg/mL demonstrated, and scalability of binding capacity shown on CIMmultus™ Oligo dT preparative scale, which spans bed volume range 1 mL – 40 L, thereby theoretically supporting the purification of >200 g mRNA in a single run. Read more.
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