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

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.