创新制剂平台：以增强的疗效和更广泛的应用为导向，推动蛋白质治疗药物的发展。
Innovative Formulation Platform: Paving the Way for Superior Protein Therapeutics with Enhanced Efficacy and Broadened Applications.
机构信息
Department of Chemical and Biomolecular Engineering, University of California, Los Angeles, CA, 90095, USA.
Beijing Advanced Innovation Center for Soft Matter Science and Engineering, College of Life Science and Technology, Beijing University of Chemical Technology, Beijing, 100029, P. R. China.
出版信息
Adv Mater. 2024 Oct;36(41):e2403116. doi: 10.1002/adma.202403116. Epub 2024 Jun 16.
Protein therapeutics offer high therapeutic potency and specificity; the broader adoptions and development of protein therapeutics, however, have been constricted by their intrinsic limitations such as inadequate stability, immunogenicity, suboptimal pharmacokinetics and biodistribution, and off-target effects. This review describes a platform technology that formulates individual protein molecules with a thin formulation layer of crosslinked polymers, which confers the protein therapeutics with high activity, enhanced stability, controlled release capability, reduced immunogenicity, improved pharmacokinetics and biodistribution, and ability to cross the blood brain barriers. Based on currently approved protein therapeutics, this formulating platform affords the development of a vast family of superior protein therapeutics with improved efficacy and broadened indications at significantly reduced cost.
蛋白质疗法具有高效能和高特异性；然而，由于其内在的局限性，如稳定性不足、免疫原性、药代动力学和生物分布不理想以及脱靶效应，蛋白质疗法的广泛应用和发展受到了限制。本综述描述了一种平台技术，该技术将交联聚合物的薄制剂层与单个蛋白质分子结合，从而赋予蛋白质疗法高活性、增强稳定性、可控释放能力、降低免疫原性、改善药代动力学和生物分布以及穿越血脑屏障的能力。基于目前已批准的蛋白质疗法，这种制剂平台为开发具有更好疗效和更广泛适应症的大量优越蛋白质疗法提供了可能，同时成本显著降低。
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