Standardization of cellular therapy terminology, coding and labeling: a review

Area of Science:

• Hematopoietic cell transplantation
• Cellular therapy
• International standardization

Background:

• Rapid growth in international hematopoietic cell transplantation activity since the 1990s.
• Establishment of national donor registries and increased international collaboration.
• Emergence of challenges in cross-border transfer of cellular therapy products due to lack of international standards.

Purpose of the Study:

• To review the historical development of international standards in hematopoietic cell transplantation.
• To highlight key milestones in achieving standardization for cellular therapy products.
• To emphasize the ongoing need for maintaining and enhancing these standards.

Main Methods:

• Review of historical data and expert consensus over two decades.
• Analysis of challenges in international import and export of cellular therapy products.
• Examination of the role of professional societies and accreditation bodies.

Main Results:

• Significant progress in achieving a high degree of international standardization for cellular therapy products.
• Identification of critical landmarks in the journey toward standardization.
• Demonstration of the need for continuous adaptation of standards.

Conclusions:

• International standardization efforts have successfully addressed import/export challenges in cellular therapy.
• A long-term perspective is essential for successful international standardization initiatives.
• Ongoing maintenance and enhancement of standards, including recent ISBT 128 developments, are vital for the cell therapy industry.