FDA Buffy Coat Method Guidance Released

The U.S. Food and Drug Administration (FDA) has published a draft guidance on October 17^th titled “Recommendations for the Development of Blood Collection, Processing, and Storage Systems for the Manufacture of Blood Components Using the Buffy Coat Method.” The agency explained that the FDA Buffy Coat Method draft guidance is for manufacturers of blood collection, processing, and storage systems. The FDA noted in the draft guidance that, “[b]lood establishments in the U.S. are interested in using the buffy coat (BC) method to manufacture blood components for transfusion. Studies demonstrate that blood components prepared by using the BC method are comparable to blood components prepared using the platelet rich plasma (PRP) method, in terms of biochemical and physiological characteristics. In addition, use of the BC method may offer logistical advantages, which could result in higher plasma and platelet recovery and increased platelet availability, when compared to the PRP method.”

However, blood collection, processing, and storage systems currently marketed in the U.S. are only approved for the preparation of blood components from whole blood using the PRP method, and none are approved or cleared for the preparation of blood components using the BC method.

Recommendations from the FDA Buffy Coat Method Guidance regarding the BC method include:

• “manufacturers should contact FDA to clarify the appropriate regulatory pathway for their blood collection, processing, and storage systems;
• when developing collection, processing, and storage systems that include anticoagulant or additive solutions for red blood cells (RBCs) and platelets, manufacturers should consider using solutions already approved by FDA;
• regulatory submissions for blood collection, processing, and storage systems should include:
  • the design of the collection, processing, and storage system;
  • a description of the established methods, facilities, and controls used for the manufacture of the blood collection, processing, and storage system;
  • biocompatibility studies and toxicologic risk assessments;
  • performance data that support sterility of the collection, processing, and storage system including sterilization validation, endotoxin testing, and container closure integrity evaluation;
  • performance data that support maximum shelf life of the collection, processing, and storage system;
  • results of studies evaluating the quality of blood components using the BC method throughout the duration of storage;
  • if the collection, processing, and storage system includes a leukocyte reduction filter, you should provide results on the performance of the leukoreduction filter;
  • manufacturers should conduct appropriate clinical studies or submit existing clinical data to demonstrate the safety and efficacy of blood components prepared using the BC method;
• FDA recommends manufacturers engage the Center for Biologics Evaluation and Research’s (CBER) Office of Blood Research and Review (OBRR) early in product development and before submission of a drug or device application.”

America’s Blood Centers (ABC) will submit comments to FDA on the draft guidance.