In draft guidance issued Monday, the US Food and Drug Administration (FDA) offered new recommendations to aid in the development of dried plasma products for blood transfusions.
The recommendations are intended to help increase the availability of and access to dried plasma, with policy clarifications ranging from optimal sources of input plasma to submissions for devices used to manufacturer these products. Considerations for manufacturing and product quality as well as packaging and reconstitution are provided in the 6-page draft guidance also.
Potential benefits of dried plasma as a substitute for transfusions emerged during World War II.
“Further development and use of dried plasma was generally discontinued in the US in large part because of infectious disease transmission risks,” FDA noted. “As mitigation of infectious disease transmission risks improved, including improved testing methods and pathogen reduction technologies, interest in the development of dried plasma products reemerged.”
In July, FDA granted
an emergency use authorization to the US Department of Defense (DoD) to use freeze-dried plasma for hemorrhage or coagulopathy treatments among military personnel during emergencies involving military combat agents such as firearms. The move came after the January launch
of an FDA-DoD joint program for the efficient development of these products.
Dried plasma products should be obtained from either a licensed single donor or pools of donations intended for transfusion, according to the draft guidance. Manufacturers using pooled donations should consider mitigation measures beyond those in the testing requirements for transfusion-transmitted infections. Quality considerations cover the areas of design, validation, documentation, characterization studies, stability testing and sterility requirements. Indication(s) for use and degree of clinical experience will dictate the needed clinical studies for approval.
Manufacturers should consider “a packaging kit that includes all the materials needed for reconstitution, including the appropriate volume of diluent, as well as specific instructions for use” as this approach to product distribution is “likely to enhance safety by minimizing errors upon reconstitution and to ensure rapid time-to-transfusion,” according to the draft guidance.
FDA anticipates devices intended for manufacturing dried plasma products will generally be subject to premarket approval requirements as class III. As part of the device for which approval is sought, applicants should include the non-standard equipment needed for processing the dried plasma product at blood establishments, validation, product characterization data and the category of input plasma unique to the device. All other considerations in the draft guidance are also relevant to the development of these devices and device outputs, the agency said.
Considerations for the Development of Dried Plasma Products Intended for Transfusion: Draft Guidance for Industry