USA – Considerations for the Development of Dried Plasma Products Intended for Transfusion

We, FDA, are providing recommendations intended to assist manufacturers, sponsors, and
applicants developing dried plasma products intended for transfusion in order to facilitate the availability of safe and effective dried plasma1 products in the United States (U.S.). This guidance provides considerations for the successful development and licensing of dried plasma products and for the approval of devices used to manufacture dried plasma. The guidance includes recommendations on optimal sources of input plasma; manufacturing and product quality, including product characterization; packaging and reconstitution; clinical studies; and device submissions. This guidance finalizes the draft guidance of the same title dated October 2018.

FDA’s guidance documents, including this guidance, do not establish legally enforceable
responsibilities. Instead, guidances describe the FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.
The use of the word should in FDA’s guidances means that something is suggested or
recommended, but not required.

II. BACKGROUND

Plasma is a critical component of early transfusion therapy in the management of traumatic
hemorrhage (Ref. 1). Plasma can replenish various coagulation proteins that are consumed
during the coagulopathy that may accompany traumatic injury (Ref. 2). Because plasma products intended for transfusion such as fresh frozen plasma (FFP), plasma frozen within 24 hours after phlebotomy (PF24), and plasma frozen within 24 hours after phlebotomy held at room temperature up to 24 hours after phlebotomy (PF24RT24) are stored frozen, these products need to be thawed prior to transfusion. This limits or prevents the use of plasma in settings where freezers and other support equipment are unavailable (e.g., battlefields, remote locations, and other austere settings), and may lead to delayed administration. Dried plasma (such as freeze-dried or spray-dried plasma) offers the potential to address these challenges by providing a product that is stable at ambient temperatures, and which can be rapidly reconstituted and transfused…