Development and validation of an enzyme linked immunosorbent assay for palivizumab serum determination

Research output: Contribution to journalArticle

3 Citations (Scopus)

Abstract

Palivizumab (Synagis®) is a humanized monoclonal antibody (IgG1 K) composed of 95% human and 5% murine sequences. It is directed to an epitope in the A antigenic site of the F protein of respiratory syncytial virus (RSV). Palivizumab is used for prevention of serious lower respiratory tract disease caused by RSV in pediatric patients who are at increased risk of severe disease and is administered intramuscularly (IM) for a total of 5 monthly doses. Herein, we report on the development and validation of a very sensitive enzyme-linked immunosorbent assay (ELISA) to measure serum concentrations of palivizumab by a rabbit polyclonal antibody specifically produced against the murine sequence. The method was developed and validated according to the guidelines "Guidance for Industry" (1998) and has proved suitable for the determination of palivizumab serum levels in the target infant population. The ELISA assay was successfully applied to test the serum samples in an infant population who received palivizumab intramuscularly; thus, the assay could be used to determine serum levels in palivizumab-treated infants to optimize dosing and scheduling and to study the relationship between dose and clinical response.

Original languageEnglish
Pages (from-to)503-510
Number of pages8
JournalInternational Journal of Immunopathology and Pharmacology
Volume26
Issue number2
Publication statusPublished - Apr 2013

Fingerprint

Enzyme-Linked Immunosorbent Assay
Serum
Respiratory Syncytial Viruses
Respiratory Tract Diseases
Antibodies, Monoclonal, Humanized
Health Services Needs and Demand
Palivizumab
Epitopes
Industry
Immunoglobulin G
Guidelines
Pediatrics
Rabbits
Antibodies
Population
Proteins

Keywords

  • ELISA
  • Infant patients
  • Palivizumab
  • Respiratory Syncytial Virus (RSV)

ASJC Scopus subject areas

  • Pharmacology
  • Immunology
  • Immunology and Allergy

Cite this

@article{b72b45cba01a4ca593bc4f77b4d36c74,
title = "Development and validation of an enzyme linked immunosorbent assay for palivizumab serum determination",
abstract = "Palivizumab (Synagis{\circledR}) is a humanized monoclonal antibody (IgG1 K) composed of 95{\%} human and 5{\%} murine sequences. It is directed to an epitope in the A antigenic site of the F protein of respiratory syncytial virus (RSV). Palivizumab is used for prevention of serious lower respiratory tract disease caused by RSV in pediatric patients who are at increased risk of severe disease and is administered intramuscularly (IM) for a total of 5 monthly doses. Herein, we report on the development and validation of a very sensitive enzyme-linked immunosorbent assay (ELISA) to measure serum concentrations of palivizumab by a rabbit polyclonal antibody specifically produced against the murine sequence. The method was developed and validated according to the guidelines {"}Guidance for Industry{"} (1998) and has proved suitable for the determination of palivizumab serum levels in the target infant population. The ELISA assay was successfully applied to test the serum samples in an infant population who received palivizumab intramuscularly; thus, the assay could be used to determine serum levels in palivizumab-treated infants to optimize dosing and scheduling and to study the relationship between dose and clinical response.",
keywords = "ELISA, Infant patients, Palivizumab, Respiratory Syncytial Virus (RSV)",
author = "Michela Montagna and L. Visai and Comite, {A. D I} and V. Iommiello and Avanzini, {M. A.} and N. Bloise and M. Stronati and M. Regazzi",
year = "2013",
month = "4",
language = "English",
volume = "26",
pages = "503--510",
journal = "International Journal of Immunopathology and Pharmacology",
issn = "0394-6320",
publisher = "Biomedical Research Press s.a.s.",
number = "2",

}

TY - JOUR

T1 - Development and validation of an enzyme linked immunosorbent assay for palivizumab serum determination

AU - Montagna, Michela

AU - Visai, L.

AU - Comite, A. D I

AU - Iommiello, V.

AU - Avanzini, M. A.

AU - Bloise, N.

AU - Stronati, M.

AU - Regazzi, M.

PY - 2013/4

Y1 - 2013/4

N2 - Palivizumab (Synagis®) is a humanized monoclonal antibody (IgG1 K) composed of 95% human and 5% murine sequences. It is directed to an epitope in the A antigenic site of the F protein of respiratory syncytial virus (RSV). Palivizumab is used for prevention of serious lower respiratory tract disease caused by RSV in pediatric patients who are at increased risk of severe disease and is administered intramuscularly (IM) for a total of 5 monthly doses. Herein, we report on the development and validation of a very sensitive enzyme-linked immunosorbent assay (ELISA) to measure serum concentrations of palivizumab by a rabbit polyclonal antibody specifically produced against the murine sequence. The method was developed and validated according to the guidelines "Guidance for Industry" (1998) and has proved suitable for the determination of palivizumab serum levels in the target infant population. The ELISA assay was successfully applied to test the serum samples in an infant population who received palivizumab intramuscularly; thus, the assay could be used to determine serum levels in palivizumab-treated infants to optimize dosing and scheduling and to study the relationship between dose and clinical response.

AB - Palivizumab (Synagis®) is a humanized monoclonal antibody (IgG1 K) composed of 95% human and 5% murine sequences. It is directed to an epitope in the A antigenic site of the F protein of respiratory syncytial virus (RSV). Palivizumab is used for prevention of serious lower respiratory tract disease caused by RSV in pediatric patients who are at increased risk of severe disease and is administered intramuscularly (IM) for a total of 5 monthly doses. Herein, we report on the development and validation of a very sensitive enzyme-linked immunosorbent assay (ELISA) to measure serum concentrations of palivizumab by a rabbit polyclonal antibody specifically produced against the murine sequence. The method was developed and validated according to the guidelines "Guidance for Industry" (1998) and has proved suitable for the determination of palivizumab serum levels in the target infant population. The ELISA assay was successfully applied to test the serum samples in an infant population who received palivizumab intramuscularly; thus, the assay could be used to determine serum levels in palivizumab-treated infants to optimize dosing and scheduling and to study the relationship between dose and clinical response.

KW - ELISA

KW - Infant patients

KW - Palivizumab

KW - Respiratory Syncytial Virus (RSV)

UR - http://www.scopus.com/inward/record.url?scp=84881230003&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84881230003&partnerID=8YFLogxK

M3 - Article

C2 - 23755766

AN - SCOPUS:84881230003

VL - 26

SP - 503

EP - 510

JO - International Journal of Immunopathology and Pharmacology

JF - International Journal of Immunopathology and Pharmacology

SN - 0394-6320

IS - 2

ER -