岩藻聚糖硫酸酯生产：审批关键挑战与机遇。

Fucoidan production: Approval key challenges and opportunities.

机构信息

Department of Pharmacognosy, Tanta University, College of Pharmacy, El Guish Street, 31527 Tanta, Egypt; Institute of Bioprocess Engineering, Technical University of Kaiserslautern, Gottlieb-Daimler-Straße 49, 67663 Kaiserslautern, Germany.

Institute of Bioprocess Engineering, Technical University of Kaiserslautern, Gottlieb-Daimler-Straße 49, 67663 Kaiserslautern, Germany.

出版信息

Carbohydr Polym. 2019 May 1;211:289-297. doi: 10.1016/j.carbpol.2019.01.105. Epub 2019 Jan 30.

DOI:10.1016/j.carbpol.2019.01.105

PMID:30824091

Abstract

Fucoidan has gained a great interest as a potential drug candidate against various diseases including anti-coagulant, anti-viral and anti-tumors activities. However, several challenges have hampered fucoidan to be a GMP-compliant product and then FDA approval. This review discussed fucoidan structure's heterogeneity, co-extracted contaminants, and ecological-related problems, which were considered as the major challenges faced fucoidan approval. Moreover, it presented novel opportunities toward homogenous production that gives high-quality, reliable and reproducible physico-chemical and clinical results. Among these opportunities are optimization of extraction and purification procedures, tissue culture techniques and enzymatic synthesis via heterologous expression of enzymes involved in its biosynthesis.

摘要

褐藻糖胶作为一种有前途的候选药物，具有抗凝血、抗病毒和抗肿瘤等多种活性，引起了广泛关注。然而，一些挑战阻碍了褐藻糖胶成为符合 GMP 标准的产品，并获得 FDA 批准。本文综述了褐藻糖胶结构的异质性、共提取的污染物和与生态相关的问题，这些问题被认为是褐藻糖胶批准的主要挑战。此外，本文还介绍了实现均质生产的新机遇，从而提供高质量、可靠和可重复的物理化学和临床结果。这些机遇包括优化提取和纯化程序、组织培养技术以及通过异源表达参与其生物合成的酶进行酶促合成。