KIYATEC, LLC — Department of Health and Human Services SBIR Phase I: NIBIB

Description

DESCRIPTION provided by applicant The D Platelet Bank A Clinical grade Scalable D Microbioreactor Bone Marrow Mimetic for Platelet Production Current methods for collecting culturing and processing donor derived platelets for immediate transfusion are inefficient costly and associated with significant regulatory safety issues including morbidity and mortality due to transfusion reactions infection or inefficacy Low numbers of volunteer donors willing to undergo apheresis collection of platelets as well as the inability to store platelets longer than days as compared to days for whole blood contributes to the significant deficiency in platelet availability Alternative donor free sources improved processing and storage of platelets represent a significant clinical need In response to this significant clinical need KIYATEC proposes to establish andquot The D Platelet Bank A Clinical grade Scalable D Microbioreactor Bone Marrow Mimetic for Platelet Production andquot To this end the company will establish a perfusion bioreactor system capable of culturing megakaryocytes MK in a more physiologic D microenvironment for the intent of producing clinically relevant quantities of platelets Initial strategy will be to establish a highly scalable and cost effective D culture system by combining the strengths of KIYATECandapos s bioreactor design manufacturing and commercialization experience with Tufts Universityandapos s biomaterial scaffold design and fabrication expertise The novel merger of the two synergistic technology platforms will represent a significant game changing leap forward in creating a donor free platelet source as an alternative to limited donor derived platelet volumes and throughput NARRATIVE Existing means for donor derived platelet sourcing and storage have significant drawbacks due in part to the inability to store platelets longer than days This fact results in severe shortages or complete lack of platelet availability for therapy in underserved and remote regions KIYATEC is working to establish an alternative donor free platelet source by designing building and applying a novel D cell culture bioreactor technology to mimic the human body s bone marrow and stimulate the production of clinically viable platelets