Abstract

In this work, the process of forming PF4/heparin complex was described based on their sizes measured with PCS. PF4/heparin complexes formed when a small amount of heparin was added to PF4, and they grew to bigger particles when more heparin was added, but they started to decompose after a certain amount of heparin was added. The larger the molecular weight of heparin has, the less amount of heparin is required to form the complex with PF4. This process was verified by the results of the complex surface charge. This method was used to compare the immunogenicity among the different batches of nadroparin after its specificity and stability were validated.

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