[The EDQM Biological Standardisation Programme for the development of methods and reference preparations].

Area of Science:

• Pharmacopoeia and Pharmaceutical Sciences
• Biotechnology and Biological Products
• Regulatory Science

Context:

• Established in 1992, the Biological Standardisation Programme (BSP) by the European Directorate for the Quality of Medicines & HealthCare (EDQM) supports European Pharmacopoeia (Ph. Eur.) quality controls.
• The BSP focuses on developing and providing reference standards, materials, and standardized methods for quality assessment of medicines.

Purpose:

• To supply essential tools for quality controls mandated by the European Pharmacopoeia.
• To develop and validate methods, particularly those replacing animal testing.
• To ensure the quality, safety, and efficacy of biological medicinal products.

Summary:

• The BSP has conducted 131 projects, establishing 121 reference materials and developing 38 methods, with 21 focused on replacing animal tests.
• Current work encompasses vaccines, plasma-derived medicines, hormones, cytokines, allergens, and methods for impurity determination.
• Collaborations include the World Health Organization (WHO) and national control laboratories, involving manufacturers in reference material development.

Impact:

• Significantly contributes to the quality, safety, and efficacy of biological medicines in Europe and globally.
• Enhances public and animal health through reliable quality control of medicinal products.
• Supports regulatory compliance and advances pharmaceutical science through method validation and standardization.