Overview of regulatory frameworks on the national lot release of plasma-derived medicinal products in Korea

Su Kyoung Seong; Young Hoon Kim; Youngju Choi; Hyun Jung Koh; Seong Jae Kim; Myoung Jun Kim; Chan Woong Choi

doi:10.1016/j.biologicals.2024.101768

Overview of regulatory frameworks on the national lot release of plasma-derived medicinal products in Korea

Biologicals. 2024 May 10:86:101768. doi: 10.1016/j.biologicals.2024.101768. Online ahead of print.

Authors

Su Kyoung Seong¹, Young Hoon Kim², Youngju Choi², Hyun Jung Koh², Seong Jae Kim², Myoung Jun Kim², Chan Woong Choi³

Affiliations

¹ Biopharmaceutical & Herbal Medicine Evaluation Department, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Cheongju, South Korea; Department of Life Science, University of Seoul, Seoul, South Korea.
² Biopharmaceutical & Herbal Medicine Evaluation Department, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Cheongju, South Korea.
³ Biopharmaceutical & Herbal Medicine Evaluation Department, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Cheongju, South Korea. Electronic address: cwchoi80@korea.kr.

PMID: 38733709
DOI: 10.1016/j.biologicals.2024.101768

Abstract

Plasma-derived medicinal products (PDMPs) are essential in the treatment of acute and chronic life-threatening diseases. The Korea Ministry of Food and Drug Safety has conducted a national lot release (NLR) of PDMPs since 2012 based on a summary protocol review system and lot release testing. However, few studies have investigated the performance or characteristics of the NLR framework. Over the past decade, the NLR of PDMPs was approximately 1000 per year, including mainly albumins, immunoglobulins, fibrin sealant kits, and coagulation factors, among others. The NLR system for PDMPs is similar to that for vaccines, except that PDMPs are manufactured using human plasma, which requires strict safety management. This study describes the status of NLR procedures for PDMPs and outlines the regulatory requirements needed to safely manage plasma for fractionation in Korea. This study can aid national control laboratories and marketing authorization holders in developing regulatory systems that assure the availability of safe and effective PDMPs.

Keywords: National lot release; Plasma for fractionation; Plasma-derived medicinal products; Regulatory requirements.