The Heparin crisis in 2008 (death of 150 patients in US between 2007-2008), was a stark reminder that biological product characterization and quality analysis needs to be supported by advanced analytical tools capable of detecting highly related compounds that can carry high toxic liabilities.
For antibody characterization, this means confirming their sequence identity and glycosylation level from batch to batch. Any variations could greatly influence their activity as therapeutics or diagnostics.
For the majority of biologics, profiling for QA/QC control, LC-UV and LC-MS methods constitute state-of-the-art, and NMR methods extends the analytical capability to other classes such as polysaccharides. Spinnovation has all this capability and expertise under one roof.
Contact us for detailed antibody characterization services including: