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

Area of Science:

• Biologics and biosimilars
• Pharmacology and pharmaceutical sciences
• Immunology

Background:

• Infliximab is a chimeric monoclonal antibody targeting Tumour Necrosis Factor (TNF).
• Standardization of Infliximab potency assays is crucial for ensuring therapeutic efficacy and patient safety.
• Existing reference materials require validation for international and pharmacopoeial use.

Purpose of the Study:

• To evaluate two Infliximab preparations for their suitability as a World Health Organization (WHO) International Standard (IS) and European Pharmacopoeia (Ph. Eur.) Biological Reference Preparation (BRP).
• To establish the first IS and Ph. Eur. BRP for Infliximab potency assays.

Main Methods:

• Two Infliximab preparations were formulated and lyophilised.
• Twenty-six laboratories participated in a collaborative study evaluating the preparations using various in vitro bioassays (cell-based and binding assays).
• Potency was assessed based on TNF-neutralisation activity and inhibitory action on TNF-alpha-induced cytotoxicity.

Main Results:

• Candidate preparation 16/170 demonstrated suitability for use as an International Standard based on biological activity data.
• Preparation 16/170 was established as the first WHO IS for Infliximab in 2017 with 500 IU/ampoule potency.
• Preparation 16/170 was also adopted as the Ph. Eur. BRP batch 1 in 2018 with an assigned potency of 500 IU/ampoule.

Conclusions:

• The collaborative study successfully established Infliximab preparation 16/170 as the first WHO IS and Ph. Eur. BRP.
• This standardized reference material will facilitate consistent and reliable potency testing of Infliximab products globally.
• The assigned potency of 500 IU per ampoule provides a crucial benchmark for Infliximab bioassays.