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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.
Peptide Map
It has been used for the initial 'proof of
structure' characterization, i.e. to confirm expression of the desired amino
acid sequence and to characterize any post-translational modifications. The
protein sample will be reduced and alkylated and then digested with suitable
enzyme ' Trypsin or Lys-C'. The digested peptide will be separated by reverse
phase HPLC and detected by an ion-trap mass spectrometer (MS and MS/MS
sequencing).
-Confirm the primary sequence of the
protein. Sequence coverage will be reported.
-Identification of posttranslational modification of
the protein including N-terminal, C-terminal, deamidation, oxidation, etc.
Percentage of the modification will be reported.
-Identification of glycosylation sites and
types (N-linked and O-linked).
According to ICH Q6B
guidelines, peptide map is the most important assay to establish product
structure of biological products for lot release purpose.
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