Structure assessment of heterogeneous polypeptide mixture
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United States of America Patent
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Jul 25, 2017
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Aug 3, 2015
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Jul 11, 2011
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Abstract
A method of manufacturing a glatiramer acetate drug product is described. The method entails measuring one or both of alpha helical content of the glatiramer acetate and random coil content of the glatiramer acetate in the batch and manufacturing a glatiramer acetate drug product using at least a portion of the glatiramer acetate when the alpha helical content and or random coil content meets certain criteria.
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