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BARDA/IED LC-MS/MS LC MS/MS<br />
Proposed Agenda<br />
� Collaboration between CBER and CFSAN for comparative<br />
studies<br />
– Implementation proposal (examples)<br />
� Preparation of standards for testing using current methods and LC-<br />
MS/MS<br />
� Comparison of past (H5) antigen standard values with LC-MS/MS<br />
� Comparison of (H5) vaccine and intermediates SRID values with LC-<br />
MS/MS<br />
� Evaluate alternative approaches to measure potency.<br />
– Immunoprecipitation<br />
– Protein mass mapping<br />
– The sialic acid - HA binding concept (NCIRD/CDC)<br />
– Other approaches
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