[Development of alternative methods by the EDQM and the Biological Standardization Program].

Area of Science:

• Pharmacology and Toxicology
• Biotechnology
• Regulatory Science

Context:

• Quality control of biologicals like vaccines and sera frequently involves animal experiments due to complex compositions and lack of alternatives.
• The European Pharmacopoeia, managed by the European Directorate for the Quality of Medicines (EDQM), sets specifications for biologicals in Europe.
• The EDQM oversees the Biological Standardisation Programme and the Official Medicines Control Laboratories (OMCL) network.

Purpose:

• To describe how the EDQM, through its various programs and networks, supports the 3R concept in biologicals quality control.
• To highlight the ongoing efforts to develop and implement alternative methods to animal testing.
• To showcase successful applications of the 3R concept in the field of biologicals standardization.

Summary:

• Biologicals quality control predominantly uses animal testing due to inherent complexities and absence of validated alternative methods.
• The EDQM, via the European Pharmacopoeia and the OMCL network, coordinates efforts to establish European reference preparations and standardize control methods.
• A key objective is the development and implementation of alternative methods, aligning with the 3R principles (Replacement, Reduction, Refinement) of animal use.

Impact:

• Facilitates the reduction and replacement of animal testing in the quality control of essential medicines like vaccines and sera.
• Promotes harmonized regulatory standards for biologicals across Europe through common reference preparations and standardized methods.
• Advances the development of more efficient, reliable, and ethical methods for ensuring the safety and efficacy of biological products.