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AABB and ARC Submit Comments to Support Manufacture of Platelets by Buffy Coat Method

December 18, 2024

AABB and the American Red Cross (ARC) submitted joint comments to the Food and Drug Administration this week in response to the agency’s draft guidance on the development of blood collection, processing and storage systems for the manufacture of blood components using the buffy coat (BC) method.

In the letter, AABB and ARC expressed support for the draft guidance, which outlines recommendations to manufacturers for the development of systems that could enable whole blood-derived platelet production using the BC method. This approach could provide an additional source of platelets to help meet increasing transfusion demands amid a declining apheresis donor base.

AABB and ARC highlighted several areas for FDA consideration:

  1. Non-DEHP blood bags: AABB and ARC urged FDA to consider the potential decline in DEHP-based blood bag production, as many manufacturers move toward non-DEHP alternatives to align with European Union regulations and patient safety priorities. The organizations urged FDA to elaborate on this topic when developing future guidance.  
  2. Ambient temperature hold: AABB and ARC called for FDA to allow an overnight ambient temperature hold for whole blood, extending the current restrictive 8-hour processing timeline. The organizations noted that this approach aligns with international practices and would significantly increase platelet production flexibility.
  3. Non-process product failures: The organizations requested FDA guidance to define, exclude and replace donor-specific product failures — those caused by donor traits rather than process errors —from testing plans.
  4. Statistical hemolysis requirements: AABB and ARC recommended that FDA adopt less stringent acceptance criteria for hemolysis testing, better aligning with international standards to reduce regulatory burdens. Should the agency retain the current acceptance criteria, the organizations asked FDA to share its justification for retaining them.
  5. Use of international clinical data: The organizations emphasized that additional U.S. clinical trials should not be required when high-quality international clinical data already demonstrate safety and efficacy. 
Through these comments, AABB and ARC strive to advance policies that foster innovation while ensuring safe and sustainable platelet production. Those with questions about the comments may contact AABB Regulatory Affairs via email.