Innovation in Blood Establishment Processes, Strasbourg, 2025: a Conference Report

Area of Science:

• Transfusion Medicine
• Regulatory Science
• Public Health

Background:

• The European Union (EU) is transitioning from existing directives to the new Substances of Human Origin (SoHO) Regulation (EU) 2024/1938, effective in 2027.
• This regulatory shift aims to harmonize approaches across the EU for substances derived from human sources.
• Ensuring high quality and safety standards for SoHO is critical for donor and recipient protection and supply chain integrity.

Purpose of the Study:

• To summarize key discussions and innovations presented at the international EDQM Blood Conference.
• To explore the implications of the upcoming SoHO Regulation on blood establishment processes.
• To foster awareness regarding the benefits and challenges associated with implementing the new SoHO Regulation.

Main Methods:

• The report is based on the proceedings and discussions from the international EDQM Blood Conference on Innovation in Blood Establishment Processes.
• Key topics and expert insights shared during the conference sessions were documented.
• The focus was on identifying innovative practices and regulatory advancements in the blood sector.

Main Results:

• The conference highlighted the significant impact of the forthcoming SoHO Regulation on harmonizing quality and safety standards for blood and blood components.
• Participants shared diverse experiences and innovative strategies in blood donation and processing.
• The discussions underscored the need for preparedness to address both the advantages and hurdles in adopting the new regulatory framework.

Conclusions:

• The implementation of the SoHO Regulation is expected to enhance health protection and ensure a stable supply of critical SoHO.
• Collaboration and knowledge sharing are vital for successfully navigating the transition to the new regulatory landscape.
• Continued innovation in blood establishment processes is essential to meet evolving healthcare needs and regulatory requirements.