WASHINGTON—A new red blood cell storage solution has recently been approved by the FDA.
Hemerus Medical LLC and its partner U.S. Army Medical Materiel Development Activity (USAMMDA), received approval of the New Drug Application for its SOLX System (LEUKOSEP HWB-600-XL Leukocyte Reduction Filtration System for Whole Blood with CPD Anticoagulant and SOLX Additive). It is the first red blood storage solution to be approved by FDA in more than 15 years, according to USAMMDA.
This system is already approved in Europe for eight-week red blood cell storage and has been approved by FDA in the United States for six-week red blood cell storage.
The development of the product was prompted by calculations showing that an additional two weeks of storage time could save DoD millions of dollars in transportation costs and decreased product loss due to product expiration during military deployments, a USAMMDA statement explained. It was also realized that “longer storage time only occurred with better quality cells.”
“This then was the genesis of a fruitful collaboration between the Army and academia, resulting in a number of peer-reviewed publications that proved the initial concept,” Victor Macdonald, product manager and blood products subject matter expert for Pharmaceutical Systems Project Management Office (PSPMO) at USAMMDA, said in a written statement. “After years of effort, a partnership was formed with industry for further development of the storage solution and incorporation into a blood collection system with commercial potential.”
According to USAMMDA, the future for this product includes “implementing a Low Rate Initial Production contract where the Army Blood Program Office can purchase the SOLX product and obtain the subsequent military blood bank Biologic License Application approvals for the plasma and red blood cells, so they can begin using the system.”