Analytical Testing
Analytical testing of purified mRNA is critical for understanding the final drug product. Multiple analytical tests such as potency assays, enzymatic digestions to study 5’ cap and 3’ PolyA tail, and transcript size and purity studies are performed. Speed of analysis and sample prep is important as mRNA can degrade quickly. Prepare samples in microplates with a Beckman Coulter Life Sciences Biomek i-Series Automated Liquid Handler, or quickly array large amounts of samples with a Beckman Coulter Life Sciences Echo Acoustic Liquid Handler and analyze for concentration and purity on a Molecular Devices SpectraMax plate reader. A SCIEX Exion 2.0 Liquid Chromatographer and ZenoTOF 7600 mass spectrometerand Phenomenex BioZen Oligo analytical HPLC columns aprovide a comprehensive analytical solution for LC-MS. Streamline the data analysis and reporting with Genedata Expressionist Software. Perform capillary electrophoresis analyses with eight samples in parallel with SCIEX Biophase 8800 Multi-Capillary Electrophoresis System. It is important to validate all analytical assay and select the proper tools that can scale to your needs.
Genedata Bioprocess increases the efficiency of the end-to-end mRNA development workflow, covering all plasmid production steps (fermentation, harvest, prep, linearization, and filtration), in vitro transcription, and necessary purification and modification operations. It includes formulation screening to identify optimal delivery systems, including lipid nanoparticle (LNP) composition tracking. It facilitates workflow automation, barcoding, and high-throughput processes, capturing all data in a structured format providing a robust data foundation for predictive modeling and AI/ML.