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Causes and Analytical Methods for Subvisible Particles Formed in Post-Marketing Biopharmaceutical Products
Yakhak Hoeji 2024;68(6):399-408
Published online December 31, 2024
© 2024 The Pharmaceutical Society of Korea.

Kyeong On Cho*, Eun Ji Jeong*, Seong Hoon Jeong**, Ki Taek Kim*,****, Kwang Joon Kim***,#, and Nam Ah Kim*,****,#

*College of Pharmacy, Mokpo National University
**BK21 FOUR Team and Integrated Research Institute for Drug Development, College of Pharmacy, Dongguk University
***College of Pharmacy, Chonnam National University
****Department of Biomedicine, Health & Life Convergence Sciences, BK21 Four, Biomedical and Healthcare Research Institute, Mokpo National University
Correspondence to: #Nam Ah Kim, College of Pharmacy, Mokpo National University, Muan, Jeollanamdo 58554, Republic of Korea
Tel: +82-61-450-2685
E-mail: namahk87@mnu.ac.kr

Kwang Joon Kim, College of Pharmacy, Chonnam National University, 77 Yongbong-ro, Buk-gu, Gwangju 61186, Republic of Korea
Tel: +82-62-530-2929
E-mail: kjkim0901@jnu.ac.kr
Received August 25, 2024; Revised September 25, 2024; Accepted September 30, 2024.
Abstract
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.
Keywords : Subvisible particles, Flow-imaging microscopy, Silicone oil, Plastic syringes

December 2024, 68 (6)
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