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We provide following services to help our
customers to fulfill CBER requirements for a “Well Characterized Product”.
Most of the assays we provide are the key parts of ICH Q6B guidelines
for structural characterization and confirmation and physicochemical
properties determination of biological products.
Glycosylation Sites Determination
The assay will be used to determine the
sites of glycosylation (both N- and O- linked). It is often used to
determine the occupancy of certain glycosylation sites to demonstrate
lot-to-lot consistency.
-Peptide mapping under reducing condition
combined with MS/MS fragmentation of glycopeptides as the key
techniques.
-Report the percentages of
glycosylation at different sites.
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