Fucoidan production: Approval key challenges and opportunities.

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.