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Related Experiment Video

Updated: May 11, 2026

Determination of the Relative Potency of an Anti-TNF Monoclonal Antibody mAb by Neutralizing TNF Using an In Vitro Bioanalytical Method

Determination of the Relative Potency of an Anti-TNF Monoclonal Antibody mAb by Neutralizing TNF Using an In Vitro Bioanalytical Method

Published on: September 16, 2017

Collaborative study for the establishment of Golimumab Biological Reference Preparation Batch 1.

M Wadhwa¹, P Rigsby², M-E Behr-Gross³

¹Medicines and Healthcare products Regulatory Agency, Biotherapeutics and Advanced Therapies, R&D Division, Blanche Lane, South Mimms, Potters Bar, UK.

Pharmeuropa Bio & Scientific Notes

|December 3, 2024

Summary

A new golimumab standard (22/116) was established as the first World Health Organization International Standard and European Pharmacopoeia Biological Reference Preparation for potency assays. This standard has an assigned potency of 500 IU/ampoule for tumor necrosis factor neutralising activity.

Keywords:

Biological Reference Preparation Biological Standardisation Programme EDQM European Pharmacopoeia Golimumab anti-Tumour Necrosis Factor monoclonal antibody

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Using Reference Reagents to Confirm Robustness of Cytokine Release Assays for the Prediction of Monoclonal Antibody Safety

Using Reference Reagents to Confirm Robustness of Cytokine Release Assays for the Prediction of Monoclonal Antibody Safety

Published on: September 15, 2023

Area of Science:

Biologics
Pharmacology
Immunology

Background:

Golimumab is a fully human monoclonal antibody targeting tumor necrosis factor (TNF).
Standardized potency assays are crucial for ensuring the quality and efficacy of biologic drugs like golimumab.

Purpose of the Study:

To evaluate a candidate preparation of golimumab for its suitability as a World Health Organization (WHO) International Standard (IS) and European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP).
To establish an international standard for the potency assay of golimumab, ensuring consistent therapeutic efficacy.

Main Methods:

A candidate preparation (22/116) was formulated and lyophilised.
Fifteen laboratories conducted collaborative studies using various cell-based TNF-α neutralisation assays.
Binding assays and antibody-dependent cellular cytotoxicity assays were also performed by a subset of laboratories.
Potency was assessed based on the inhibitory action of golimumab on TNF-α cytotoxic activity using specific cell lines.

Main Results:

The candidate preparation 22/116 demonstrated suitability for use as a WHO IS and Ph. Eur. BRP based on biological activity and stability data.
Preparation 22/116 was established in 2024 as the first WHO IS for golimumab with an assigned potency of 500 IU per ampoule for TNF neutralising activity.
The Ph. Eur. Commission adopted preparation 22/116 as Golimumab BRP batch 1 in June 2024, also with an assigned potency of 500 IU/ampoule.

Conclusions:

The candidate preparation 22/116 is suitable to serve as both the WHO IS and Ph. Eur. BRP for golimumab potency assays.
The establishment of this standard provides a crucial reference for the quality control of golimumab products worldwide.
This standardization will facilitate consistent and reliable potency measurements of golimumab, supporting its therapeutic use.