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This webinar addresses a critical biological bottleneck in bioresorbable implants: the “Endotoxin Trap.” Recent research reveals that as biomaterials degrade, they slowly release trapped endotoxins, inducing Stress-Induced Premature Senescence (SIPS) and completely freezing tissue regeneration. Traditional purification methods hit a technical dead end, either degrading the polymer’s molecular weight or causing membrane clogging due to high viscosity. To resolve this, NAGASE introduces a proprietary molecular-level selective adsorption technology (the Arcofeliz™ series). By targeting only the toxic Lipid A core, this non-destructive method achieves ultra-low endotoxin levels while highly preserving the polymer’s viscosity, molecular weight, and mechanical properties. Designed to assist medical device developers in meeting strict FDA guidelines, USP <161>, and European MDR requirements, this session presents a seamless development pathway from R&D to commercial-scale contract purification services, helping manufacturers turn regulatory hurdles into a powerful competitive edge.
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