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In-process control for the manufacture of glatiramer acetate
专利权人:
Mani S. Iyer
发明人:
Mani S. Iyer,Harper Kaminski
申请号:
US13607625
公开号:
US08575198B1
申请日:
2012.09.07
申请国别(地区):
US
年份:
2013
代理人:
摘要:
The present disclosure provides methods for manufacturing or producing glatiramer acetate having a Mp of 5000-9000 Da. These methods include: polymerizing N-carboxy anhydrides of L-alanine, benzyl-protected L-glutamic acid, trifluoroacetic acid (TFA)-protected L-lysine, and L-tyrosine to generate a sample comprising intermediate-1 treating the sample comprising intermediate-1 to partially depolymerize the protected copolymer and deprotect benzyl-protected L-glutamic acid, measuring the viscosity of the sample comprising intermediate-1 during the treatment, and ending the treatment when the viscosity of the sample is within an endpoint range, thereby generating a sample comprising intermediate-2 treating the sample comprising intermediate-2 to deprotect TFA-protected L-lysine, thereby generating intermediate-3 further processing the intermediate-3 to generate a sample glatiramer acetate and purifying the glatiramer acetate to generate a composition comprising purified glatiramer acetate having a Mp of 5000-9000 Da.
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