PMID- 30992162
OWN - NLM
STAT- MEDLINE
DCOM- 20191125
LR  - 20191125
IS  - 1095-8320 (Electronic)
IS  - 1045-1056 (Linking)
VI  - 59
DP  - 2019 May
TI  - Correlation between the results of two analytical methods for measuring measles 
      virus neutralizing antibodies in source plasma and therapeutic immunoglobulin 
      products.
PG  - 20-28
LID - S1045-1056(19)30027-2 [pii]
LID - 10.1016/j.biologicals.2019.03.009 [doi]
AB  - Patients with primary immunodeficiency disorders are vulnerable to infectious 
      diseases. Intravenous immunoglobulin (IVIG) therapeutic products manufactured 
      from human plasma are employed widely to protect patients from pathogens such as 
      measles virus, which causes a potentially fatal and contagious disease. 
      Therefore, health authorities stipulate a minimum titer of measles neutralizing 
      antibodies (mnAbs) in IVIG products to ensure efficient protection. In general, 
      mnAb titers are measured in a cell-based neutralization assay; however, this 
      assay is labor intensive and time consuming, and the results are variable. Here, 
      we compared a cell-based neutralizing assay with several ELISA tests to evaluate 
      whether ELISAs can overcome the limitations of cell-based assays. The mnAb 
      concentrations measured by the ELISAs showed a strong and significant positive 
      correlation with those measured in a cell-based assay. Also, strong positive 
      correlations were identified for measurement of individual source plasmas, which 
      are used as raw materials for manufacturing IVIG products. Measurement by ELISA 
      revealed that about 80% of 198 source plasmas had mnAb concentrations of <500 
      mIU/mL. These results suggest that quantitative ELISAs based on relevant antigens 
      allow reliable and comprehensive measurement of mnAb concentrations in source 
      plasmas and drug product; these ELISAs are also faster and more accurate than 
      cell-based assay.
CI  - Copyright (c) 2019 The Authors. Published by Elsevier Ltd.. All rights reserved.
FAU - Hong, Jeungwoon
AU  - Hong J
AD  - Department of Biotechnology, College of Life Sciences and Biotechnology, Korea 
      University, 02841, Anam-dong, Seoungbuk-gu, Seoul, Republic of Korea; GC Pharma., 
      Ihyeon-ro 30 Beon-gil 107, Giheung-gu, Yongin-si, Gyeonggi-do, 16924, Republic of 
      Korea. Electronic address: jwhong@greencross.com.
FAU - Kim, Daegeun
AU  - Kim D
AD  - GC Pharma., Ihyeon-ro 30 Beon-gil 107, Giheung-gu, Yongin-si, Gyeonggi-do, 16924, 
      Republic of Korea. Electronic address: dgkim@greencross.com.
FAU - Won, Younhee
AU  - Won Y
AD  - GC Pharma., Ihyeon-ro 30 Beon-gil 107, Giheung-gu, Yongin-si, Gyeonggi-do, 16924, 
      Republic of Korea. Electronic address: yhwon@greencross.com.
FAU - Yoon, Jungsoon
AU  - Yoon J
AD  - GC Pharma., Ihyeon-ro 30 Beon-gil 107, Giheung-gu, Yongin-si, Gyeonggi-do, 16924, 
      Republic of Korea. Electronic address: jsyoon@greencross.com.
FAU - Park, Kuk Jin
AU  - Park KJ
AD  - GC Pharma., Ihyeon-ro 30 Beon-gil 107, Giheung-gu, Yongin-si, Gyeonggi-do, 16924, 
      Republic of Korea. Electronic address: pkjpsj@greencross.com.
FAU - Oh, Jaetaek
AU  - Oh J
AD  - GC Pharma., Ihyeon-ro 30 Beon-gil 107, Giheung-gu, Yongin-si, Gyeonggi-do, 16924, 
      Republic of Korea. Electronic address: jtoh@greencross.com.
FAU - Kim, Chan-Wha
AU  - Kim CW
AD  - Department of Biotechnology, College of Life Sciences and Biotechnology, Korea 
      University, 02841, Anam-dong, Seoungbuk-gu, Seoul, Republic of Korea. Electronic 
      address: cwkim@korea.ac.kr.
LA  - eng
PT  - Journal Article
DEP - 20190413
PL  - England
TA  - Biologicals
JT  - Biologicals : journal of the International Association of Biological 
      Standardization
JID - 9004494
RN  - 0 (Antibodies, Neutralizing)
RN  - 0 (Antibodies, Viral)
RN  - 0 (Immunoglobulins, Intravenous)
SB  - IM
MH  - Antibodies, Neutralizing/*immunology
MH  - Antibodies, Viral/*immunology
MH  - Drug Contamination/prevention & control
MH  - Enzyme-Linked Immunosorbent Assay/methods
MH  - Humans
MH  - Immunoglobulins, Intravenous/*immunology/therapeutic use
MH  - Immunologic Deficiency Syndromes/drug therapy/*immunology
MH  - Measles virus/*immunology
MH  - Neutralization Tests/*methods
MH  - Reproducibility of Results
OTO - NOTNLM
OT  - Correlation
OT  - Intravenous immunoglobulin
OT  - Measles neutralizing antibody
OT  - Source plasma
OT  - TCND(50)
OT  - mnAbs ELISA
EDAT- 2019/04/18 06:00
MHDA- 2019/11/26 06:00
CRDT- 2019/04/18 06:00
PHST- 2018/12/17 00:00 [received]
PHST- 2019/03/08 00:00 [revised]
PHST- 2019/03/31 00:00 [accepted]
PHST- 2019/04/18 06:00 [pubmed]
PHST- 2019/11/26 06:00 [medline]
PHST- 2019/04/18 06:00 [entrez]
AID - S1045-1056(19)30027-2 [pii]
AID - 10.1016/j.biologicals.2019.03.009 [doi]
PST - ppublish
SO  - Biologicals. 2019 May;59:20-28. doi: 10.1016/j.biologicals.2019.03.009. Epub 2019 
      Apr 13.