Culture-Derived Human Platelets for Clinical Transfusion

Platelets are a vital component of human blood due to their role in clotting. Despite the incredible importance of platelets for human survival, there is very little supply of platelets to meet the clinical demand. Currently, platelets are only supplied from donations, whether through whole blood or apheresis. Therefore, there is a need for ex vivo means of producing platelets at a price that is competitive with the current market price. This project seeks to meet 65% of the demand for platelets in Philadelphia by producing platelets ex vivo in a process that utilizes shear stress to induce platelet formation from megakaryocytes. To begin this batch process, induced pluripotent stem cells derived from bone marrow are proliferated over the course of 10 days. During a 20-day differentiation phase that occurs in 2 parallel 2000 L stirred single-use bioreactors, a number of growth factors are supplied to the stem cell culture to induce differentiation of the cells into megakaryocytes. The megakaryocytes, once mature, are exposed to shear stress in a specially developed microfluidic device, inspired by the work done in Dr. Daeyeon Lee’s lab, to induce platelet formation. Once platelets have been generated, they are processed over the course of 5 days to be separate, washed, and concentrated in a resuspension solution via a series of centrifugation and mixing steps, after which they will be packaged into platelet units and transported to surrounding hospitals for clinical transfusion. This process design results a yearly production of 69,550 300 mL platelet units each year, with a platelet count of 5.5x1010 platelets in each unit. For this process, the IRR is 28.99%, the NPV is 14.4 million in the year 2030, and ROI is 23.21%.