Correlation between the results of two analytical methods for measuring measles virus neutralizing antibodies in source plasma and therapeutic immunoglobulin products

Jeungwoon Hong, Daegeun Kim, Younhee Won, Jungsoon Yoon, Kuk Jin Park, Jaetaek Oh, Chan Wha Kim

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
JournalBiologicals
DOIs
Publication statusPublished - 2019 Jan 1

Fingerprint

Measles virus
Plasma sources
Neutralizing Antibodies
Viruses
Antibodies
Immunoglobulins
Assays
Enzyme-Linked Immunosorbent Assay
Intravenous Immunoglobulins
Therapeutics
Plasma (human)
Measles
Pathogens
Antigens
Drug products
Communicable Diseases
Raw materials
Health
Personnel
Pharmaceutical Preparations

Keywords

  • Correlation
  • Intravenous immunoglobulin
  • Measles neutralizing antibody
  • mnAbs ELISA
  • Source plasma
  • TCND

ASJC Scopus subject areas

  • Biotechnology
  • Bioengineering
  • Applied Microbiology and Biotechnology
  • Immunology and Microbiology(all)
  • Pharmacology

Cite this

Correlation between the results of two analytical methods for measuring measles virus neutralizing antibodies in source plasma and therapeutic immunoglobulin products. / Hong, Jeungwoon; Kim, Daegeun; Won, Younhee; Yoon, Jungsoon; Park, Kuk Jin; Oh, Jaetaek; Kim, Chan Wha.

In: Biologicals, 01.01.2019.

Research output: Contribution to journalArticle

@article{896aa20cac564430b9fee08393828553,
title = "Correlation between the results of two analytical methods for measuring measles virus neutralizing antibodies in source plasma and therapeutic immunoglobulin products",
abstract = "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.",
keywords = "Correlation, Intravenous immunoglobulin, Measles neutralizing antibody, mnAbs ELISA, Source plasma, TCND",
author = "Jeungwoon Hong and Daegeun Kim and Younhee Won and Jungsoon Yoon and Park, {Kuk Jin} and Jaetaek Oh and Kim, {Chan Wha}",
year = "2019",
month = "1",
day = "1",
doi = "10.1016/j.biologicals.2019.03.009",
language = "English",
journal = "Biologicals",
issn = "1045-1056",
publisher = "Academic Press Inc.",

}

TY - JOUR

T1 - Correlation between the results of two analytical methods for measuring measles virus neutralizing antibodies in source plasma and therapeutic immunoglobulin products

AU - Hong, Jeungwoon

AU - Kim, Daegeun

AU - Won, Younhee

AU - Yoon, Jungsoon

AU - Park, Kuk Jin

AU - Oh, Jaetaek

AU - Kim, Chan Wha

PY - 2019/1/1

Y1 - 2019/1/1

N2 - 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.

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.

KW - Correlation

KW - Intravenous immunoglobulin

KW - Measles neutralizing antibody

KW - mnAbs ELISA

KW - Source plasma

KW - TCND

UR - http://www.scopus.com/inward/record.url?scp=85064130086&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=85064130086&partnerID=8YFLogxK

U2 - 10.1016/j.biologicals.2019.03.009

DO - 10.1016/j.biologicals.2019.03.009

M3 - Article

C2 - 30992162

AN - SCOPUS:85064130086

JO - Biologicals

JF - Biologicals

SN - 1045-1056

ER -