FDA - Testing of Cells and Tissues Donors for Transferable Diseases

Recommendation

9/10 May 2023
Heidelberg, Germany

Annex 2 & Co. - GMP Compliance for Biopharmaceuticals
Regulatory Requirements and Practical Implementation

The FDA clearly requires in its guidelines that donors of cells, tissues, and cellular or tissue-based products must be tested for relevant pathogens and diseases (Testing Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/P): Specific Requirements). For that purpose tests licensed, approved or cleared by the FDA must be used.  For example, for all donors, this applies to tests for 

• HIV Type1 
• HIV Type2 
• HBV 
• HCV 
• Treponema pallidum

In certain cases, moreover, the tests for

• West Nile Virus 
• Human T-Lymphtropic Virus 
• Cytomegalovirus 
• Chlamydia trachomatis 
• Neisseria gonorrhea

Since this affects a wide variety of pathogens or diseases and also a very heterogeneous group of products of biological origin, the FDA provides an overview on their page "Testing Human Cells, Tissues, and Cellular and Tissue Based Product (HCT/P) Donors for Relevant Communicable Disease Agents and Diseases":

• Approved donor screening tests 
• Approved nucleic acid tests for Chlamydia trachomatis and Neisseria gonorrhoeae 
• Approved donor screening tests for Cytomegalovirus 
• Approved donor screening tests for Treponema pallidum.

On the same page you can also find the links to the related relevant pages about the topics

• Tissue Safety & Availability 
• Tissue & Tissue Products 
• Cellular & Gene Therapy Products

In addition, the page also links to more detailed information about tests currently recommended to adequately and appropriately reduce the risk of transmission of relevant communicable pathogens and diseases under § 1271.80.

To find more detailed information please visit the FDA website at "Testing Human Cells, Tissues, and Cellular and Tissue Based Product (HCT/P) Donors for Relevant Communicable Disease Agents and Diseases".