시판 후 바이오의약품의 비가시성 미립자 생성 원인 및 분석법

• 영문명: Causes and Analytical Methods for Subvisible Particles Formed in Post-Marketing Biopharmaceutical Products
• 발행기관: 대한약학회
• 저자명: 조경온(Kyeong On Cho) 정은지(Eun Ji Jeong) 정성훈(Seong Hoon Jeong) 김기택(Ki Taek Kim) 김광준(Kwang Joon Kim) 김남아(Nam Ah Kim)
• 간행물 정보: 『약학회지』제68권 제6호(2024년), 399~408쪽, 전체 10쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2024.12.31

국문 초록

The aggregation and formation of subvisible particles in biopharmaceuticals can occur at various stages, including bioprocesses such as mixing, stirring, pumping, transportation, and even immediately before and even during administration. These particles have the potential to adversely affect product quality, leading to unforeseen side effects, particularly severe immune responses. This review explores reported cases of adverse effects linked to subvisible particles, as well as recent studies that clarify the mechanisms behind particle formation in post-marketing biopharmaceuticals. Furthermore, it compares the analytical methods and devices applied, drawing on the guidelines provided by the Korean Pharmacopoeia (KP) and the United States Pharmacopeia (USP). Additionally, the review suggests the introduction of flow-imaging microscopy (FI) as a method for analyzing transparent particles that are challenging to detect using conventional methods such as light obscuration (LO). In conclusion, selecting appropriate methods to monitor subvisible particles during product development and optimizing hospital preparations can reduce the particle delivery to patients, thereby enhancing patient care.

목차

서 론(Introduction)

본 론(Body)

시판 후 바이오의약품의 비가시성 미립자에 의한 부작용 사례

바이오의약품 조제 중 비가시성 미립자 생성 사례

결 론(Conclusion)

감사의말씀(Acknowledgment)

Conflict of Interest

References

키워드

Subvisible particles Flow-imaging microscopy Silicone oil Plastic syringes

참고문헌

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