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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.
Disulfide Bond Pattern Determination
According to ICH guidelines, based on the
gene sequence for the desired product, the number and positions of any
free sulfhydryl groups and /or disulfide bridges should be determined
to the extent possible.
-Peptide mapping under non-reducing and
reducing conditions will be the key techniques to evaluate the mis-matched
disulfide bond.
-MS/MS fragmentation of disulfide linked
peptides for identification.
-Report percentage of free
sulfhydryl groups or mis-matched disulfide bond.
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