Preparation and characterization of polymyxin B- and histidine-coupled magnetic nanoparticles for purification of biologics from acquired endotoxin contamination
Abstract:Background
Endotoxin is a major process-related impurity that can act as a strong immunostimulant leading to fever and hypotensive shock. Thus, the US FDA and international quality standards strictly direct the biologics manufacturers to control the endotoxin contamination during the purification process. In this work, a developed method for biologics purification from acquired endotoxin contamination is introduced. This is accomplished by the preparation of dextran-coated magnetic nanoparticle… Show more
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