Jove
Visualize
Contact Us
JoVE
x logofacebook logolinkedin logoyoutube logo
ABOUT JoVE
OverviewLeadershipBlogJoVE Help Center
AUTHORS
Publishing ProcessEditorial BoardScope & PoliciesPeer ReviewFAQSubmit
LIBRARIANS
TestimonialsSubscriptionsAccessResourcesLibrary Advisory BoardFAQ
RESEARCH
JoVE JournalMethods CollectionsJoVE Encyclopedia of ExperimentsArchive
EDUCATION
JoVE CoreJoVE BusinessJoVE Science EducationJoVE Lab ManualFaculty Resource CenterFaculty Site
Terms & Conditions of Use
Privacy Policy
Policies

Related Concept Videos

You might also read

Related Articles

Articles linked to this work by shared authors, journal, and citation graph.

Sort by
Same author

Polymer Matrices for Reversible Thermogelling Hydrogels: Principles, Fabrication, and Drug Delivery Prospects.

Polymers·2026
Same author

Development of Ketoprofen Impurity A (1-(3-Benzoylphenyl)ethanone) as a Certified Reference Material for Pharmaceutical Quality Control.

Pharmaceuticals (Basel, Switzerland)·2025
Same author

An Overview of Adalimumab Therapy for Ankylosing Spondylitis.

Current rheumatology reviews·2024
Same author

Solid-Phase Microextraction Techniques and Application in Food and Horticultural Crops.

Molecules (Basel, Switzerland)·2023
Same author

Investigation of Polyphenolic Compounds in Different Varieties of Black Chokeberry <i>Aronia melanocarpa</i>.

Molecules (Basel, Switzerland)·2023
Same author

Coherent Anti-Stokes Raman Scattering Measurements of Time and Length Scales of Temperature Fluctuations in a Turbulent Flame.

Applied spectroscopy·2023
Same journal

Precision Proteomic Profiling of Systemic Lupus Erythematosus-Correlating Disease Activity and Complement Levels with Clinical Phenotypes.

Biomedicines·2026
Same journal

The Role of Salivary Microbiota in Pancreatic Cancer: From Screening to Tumor Progression and Treatment Response.

Biomedicines·2026
Same journal

Diagnostic Utility of Surface Electromyography for Identifying Muscles Affected by Myofascial Trigger Points: A Scoping Review.

Biomedicines·2026
Same journal

Performance Assessment of a Locally Semi-Automated NGS-Based Workflow for Homologous Recombination Deficiency Testing in High-Grade Serous Ovarian Carcinoma.

Biomedicines·2026
Same journal

Coupling and Uncoupling Pleiotropy Between Hypertension and Type 2 Diabetes Contribute to Exploring Potential Heterogeneity in Cardiovascular Risk in East Asian Population.

Biomedicines·2026
Same journal

Maternal Response to Therapeutic Plasma Exchange in Early Gestation: A Case Series of Thrombotic Microangiopathies and Neurological Disorders.

Biomedicines·2026
See all related articles

Related Experiment Video

Updated: Aug 22, 2025

In Vitro ELISA Test to Evaluate Rabies Vaccine Potency
09:04

In Vitro ELISA Test to Evaluate Rabies Vaccine Potency

Published on: May 11, 2020

12.7K

Affinity Capture Elution (ACE) ELISA Method Development and Validation for Novel RPH-104 Drug Immunogenicity

Maria A Kolganova1, Elizaveta V Melnik2, Elizaveta N Fisher1,2

  • 1LLC 'Center of Pharmaceutical Analytics', 117246 Moscow, Russia.

Biomedicines
|November 11, 2022
PubMed
Summary
This summary is machine-generated.

A new bioanalytical method was developed for immunogenicity testing of RPH-104, an Interleukin-1 (IL-1) inhibitor drug. This validated Affinity Capture Elution (ACE) ELISA method is sensitive, specific, and suitable for clinical sample analysis.

Keywords:
ACEADAELISARPH-104bioanalytical methodimmunogenicityinterleukin-1validation

More Related Videos

Conversion of a Capture ELISA to a Luminex xMAP Assay using a Multiplex Antibody Screening Method
14:48

Conversion of a Capture ELISA to a Luminex xMAP Assay using a Multiplex Antibody Screening Method

Published on: July 6, 2012

43.7K
Activated Cross-linked Agarose for the Rapid Development of Affinity Chromatography Resins - Antibody Capture as a Case Study
07:53

Activated Cross-linked Agarose for the Rapid Development of Affinity Chromatography Resins - Antibody Capture as a Case Study

Published on: August 16, 2019

9.3K

Related Experiment Videos

Last Updated: Aug 22, 2025

In Vitro ELISA Test to Evaluate Rabies Vaccine Potency
09:04

In Vitro ELISA Test to Evaluate Rabies Vaccine Potency

Published on: May 11, 2020

12.7K
Conversion of a Capture ELISA to a Luminex xMAP Assay using a Multiplex Antibody Screening Method
14:48

Conversion of a Capture ELISA to a Luminex xMAP Assay using a Multiplex Antibody Screening Method

Published on: July 6, 2012

43.7K
Activated Cross-linked Agarose for the Rapid Development of Affinity Chromatography Resins - Antibody Capture as a Case Study
07:53

Activated Cross-linked Agarose for the Rapid Development of Affinity Chromatography Resins - Antibody Capture as a Case Study

Published on: August 16, 2019

9.3K

Area of Science:

  • Bioanalytical Chemistry
  • Immunology
  • Pharmacology

Background:

  • Growing number of therapeutic protein products necessitates robust bioanalytical methods.
  • Immunogenicity evaluation is critical for therapeutic protein safety and efficacy.
  • RPH-104, an Interleukin-1 (IL-1) inhibitor, is under clinical investigation for various diseases.

Purpose of the Study:

  • To develop and validate a sensitive and specific bioanalytical method for immunogenicity testing of RPH-104.
  • To utilize the Affinity Capture Elution (ACE) ELISA technique for this purpose.
  • To ensure the method's suitability for analyzing clinical samples.

Main Methods:

  • Development of an Affinity Capture Elution (ACE) ELISA assay.
  • Validation of the method for key parameters: assay cut-point, sensitivity, selectivity, drug tolerance, hook effect, specificity, precision, and stability.
  • Testing specificity against relevant interfering compounds (IL-1α, IL-1β, IL1-Ra).

Main Results:

  • The developed ACE ELISA method demonstrated a sensitivity of 114.9 ng/mL.
  • Low and high positive controls were established at 155 ng/mL and 2500 ng/mL anti-RPH-104 antibody concentrations, respectively.
  • Method specificity was confirmed, and the assay was successfully applied to subject samples.

Conclusions:

  • A validated ACE ELISA method for RPH-104 immunogenicity testing has been successfully developed.
  • The method is sensitive, specific, and robust, meeting the requirements for bioanalytical testing.
  • This assay is suitable for application in clinical studies involving RPH-104.