PROCESS FOR MANUFACTURING GLATIRAMER ACETATE PRODUCT
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United States of America Patent
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Oct 19, 2017
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Jan 28, 2015
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Abstract
The patent provides a process of preparing a pharmaceutical preparation of glatiramer acetate and mannitol in a suitable container comprising the steps of:
- (i) obtaining an aqueous pharmaceutical solution of glatiramer acetate and mannitol;(ii) filtering the aqueous pharmaceutical solution at a temperature of from above 0° C. up to 17.5° C. to produce a filtrate; and(iii) filling the suitable container with the filtrate obtained after performing step (ii), so as to thereby prepare the pharmaceutical preparation of glatiramer acetate and mannitol in the suitable container.
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