Abstract: A computing device-implemented method for automated tracking and optimization of global manufacturing and supply based on impacts of post-approval changes (PACs) is discussed. An exemplary method includes retrieving data from data sources including at least an inventory database, a regulatory database, and a PAC information database. The method further includes analyzing the retrieved data to identify one or more impacts of at least one PAC on one or more drug products or drug substances using a predefined ruleset for determining which changes were implemented for each lot. The method also includes generating a list of the identified one or more impacts on the one or more drug products or drug substances.

Abstract: The present invention relates to a method for specifically measuring sialylation of a biomolecule of interest without the interference of other biomolecules present in the sample.

Abstract: Provided herein methods and kits for detecting and/or quantifying sialic acid content of glycosylated molecules that does not require purification of the glycosylated molecule of interest or purification of the labeled product. The methods and kits provided herein are fast and suitable for high-throughput use.