Alginate as a Biomaterial: Status of Product Approvals for Biomedical Engineering Applications

바이오소재로서의 알지네이트: 의공학적 활용을 위한 제품 허가 현황

Alginate is a naturally occurring anionic polysaccharide, primarily derived from brown algae and certain bacterial species, and is widely recognized for its excellent biocompatibility, biodegradability, and low immunogenicity. Owing to its tunable gelation behavior, mucoadhesive properties, and high drug encapsulation capacity, alginate has found broad application in wound healing, tissue engineering, drug delivery, and biomedical device fabrication. Despite its increasing commercialization, regulatory frameworks governing alginate as a raw material remain insufficient particularly in the Republic of Korea, where approvals are issued at the product level without standardized specifications for the raw material. In contrast, the United States has established material-specific standards through USP monographs and FDA guidelines. This review critically evaluates the current status of domestically approved alginate-based products, outlines the essential technical documentation required for regulatory approval, and highlights the lack of harmonized, material-level standards. The study emphasizes the urgent need for standardized specifications for alginate as a raw biomaterial to enhance product quality, ensure batch-to-batch consistency, and promote international regulatory alignment, ultimately facilitating its safe, consistent, and effective use in biomedical engineering applications.