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Study for the Establishment of the Ph. Eur. Human Anti-D immunoglobulin Biological Reference Preparation batch 2

Year: 2025

Type: article

Abstract: IS for anti-D Immunoglobulin in line with the stability study performed during its establishment and confirmed its suitability for use as BRP2. In October 2024, the Ph. Eur. Commission officially adopted the candidate batch as Ph. Eur. Human Anti-D immunoglobulin BRP batch 2 with an assigned potency of 297 IU/ampoule. The activity of the new batch of Ph. Eur. Anti-D immunoglobulin BRP will be regularly monitored.

Source: PubMed

DOI: 10.82453/biosn-2025-01-en

Author: European Directorate for the Quality of Medicines & HealthCare

Institution: Conseil de L'Europe

Language: English

Topic: Monoclonal and Polyclonal Antibodies Research

Subfield: Radiology, Nuclear Medicine and Imaging

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: green

OpenAlex ID: W4407388436

FWCI:

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