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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.
Size Exclusion HPLC
The
sample will be analyzed by size exclusion HPLC under non-denaturing
condition using a Tosoh Biosep column. The purity of the product will
be reported for the main peak. In addition, the percentages of
aggregate, and fragment peaks of the product will also be reported.
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