European Pharmacopoeia updates monoclonal antibody standards

The European Pharmacopoeia (Ph. Eur.) has published its first monoclonal antibody (mAb) medicinal product monograph for the IgG1-antibody based TNF-alpha antagonist, Golimumab injection (3187).

Included in Issue 12.2, the publication represents a milestone for the European Pharmacopoeia Commission in developing public standards for mAbs.

An additional monograph, Golimumab concentrated solution (3103), for another anti-TNF-alpha mAb was developed in parallel but using the single-source approach.

The new monograph will come into force on 1 April 2026.

Meanwhile, the Ph. Eur. Commission adopted seven new monographs and two new general chapters at its 183rd session last month.

The new additions in 81 texts include general chapters Uniformity of delivered dose of inhalation and nasal preparations (2.9.54), elaborated jointly with the Japanese Pharmacopoeia, and Size-exclusion chromatography for recombinant therapeutic monoclonal antibodies (2.5.43).

Also, monographs on Caspofungin acetate (3029), Cabazitaxel (3223), Geranium oil (3005), Chicory root (2948), Cat’s claw bark (2530), Linagliptin (3173) and Nintedanib esilate (3237).

Furthermore, the EPC revised 72 texts including:

• General chapters on High-performance thin-layer chromatography of herbal products (2.8.25) and Balances for analytical purposes (2.1.7)
• General chapters Particulate contamination: sub-visible particles (2.9.19) and Disintegration of tablets and capsules (2.9.1), to modernise the testing for sub-visible particles in 2.9.19 and harmonise the apparatus for large dosage forms in 2.9.1. 

Following publication in the April 2026 issue of the Ph. Eur., these texts will become effective on 1 January 2027.

The full list of texts adopted by Ph. Eur. will be available to view here in the coming weeks.

The Commission plans future work elaborating 17 separate texts, including eight individual monographs triggered by the EU list of critical medicines, as well as a general chapter on analysing nitrites in excipients.

Moreover, the Ph. Eur. said it will soon publish details online of a “milestone” it has reached in promoting animal-free methods in the field of bacterial endotoxin testing (BET).