Terumo Blood and Cell Technologies has won a $10.6 million contract from the US Government to continue freeze-dried plasma (FDP) development.
Apheresis services firm Terumo Blood and Cell Technologies has entered into a contract with the Medical Technology Enterprise Consortium (MTEC), which is an Other Transaction Agreement (OTA) with the US Army Medical Research and Development Command.
In 2016, Terumo was awarded initial funding of $1.9 million (potential to be increased to $16 million) from the US Government to support the development of FDP product.
The firm says the latest round of funding will further advance product development, enable Terumo to improve reasonable and safe access to blood therapies, and ultimately bring the product to market.
“There are 4 primary uses for this funding:
- Achieving first human use readiness of the Terumo FDP system, which includes significant in-vitro verification studies of plasma processed using the system as well as engineering verification of the system components.
- Establishing a pilot production line to produce clinical grade FDP processing kits.
- Detailed planning and preparation for future clinical trials to support regulatory submissions.
- Supported by the three activities above, compile and submit an IDE to the US FDA, said Chetan Makam, general manager, Global Blood Solutions, Terumo Blood and Cell Technologies.”
According to Terumo, FDP can potentially offer multiple advantages over conventional frozen plasma in emergency bleeding where time is a critical factor. The majority of plasma today is frozen, and thawing can take a substantial amount of time and might not be available in specific situations.
Once thawed, the plasma is then suitable for transfusion for around five days when it is refrigerated in the correct conditions. Instead, FDP can be suitably kept at room temperature and is ready within minutes after reconstructing it with medical-grade water.
“We anticipate initially, this product makes plasma more available and practical for use in the treatment of significant bleeding; in and over time with additional clinical evidence can expand the locations where plasma is available,” Makam told us.
“Imagine in the future, having this product in ambulances, long distance trucks, trains and planes similar to a defibrillator that is now ubiquitous. Imagine this is in a medic’s backpack in conflict and natural disaster relief missions versus having to evacuate the wounded to medical care locations. It could mean that one gets treated immediately and that could make a difference.”
The firm says its technology, which is currently under development, uses bags that resemble standard blood bags to reconstitute the freeze-dried powder quickly. But the firm said, “a widespread launch is still years away.”