Single-use technologies (SUTs), in particular single-use bioreactors (SUBs), represent an important improvement in biopharmaceutical manufacturing due to reduced requirements for cleaning and sterilization while providing increased sterility assurance, reduced manufacturing turnaround times, and the elimination of cleaning validation and its associated costs.
However chemicals used in their manufacture can migrate out of the system and accumulate as leachables jeopardizing bioprocess performance and cause cell growth inhibition, loss of expensive cell lines, and reduced yields. However challenges with E&L to name a few include long extraction times using Soxhlet, cross contamination & confident identification of unknowns..
New Appnote available: ASE for the determination of extractables & leachables in single use bioreactor bags
Application benefits here described include;
• Automated, rapid & highly reproducible extraction of compounds from bioreactor bags easily controlled through Chromeleon™ software using a eWorkflow including all method conditions required with minimal risk of cross contamination
• Perform high-throughput routine E&L analysis using Vanquish™ Flex UHPLC coupled with a Thermo Scientific™ Orbitrap™ mass spectrometer
• Powerful MS/MS data interpretation of fragmentation spectra using Mass Frontier™ 8.0 software
• Achieve high-quality HRAM MS and MS2 data acquired with high scan speed and fast polarity switching
• Obtain confident results using intelligent data processing software with parallel searching of multiple databases
• Increase overall E&L analysis quality and efficiency
• Deconvolution, library searching and intelligent peak annotations using compound discoverer™ 3.2 software
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