|Acquisition Program: ||MRMC Deputy for Acqusition|| Objective: ||Develop, demonstrate, and validate through lot consistency trials a cost-effective way to produce and deliver allogeneic stem cells, progenitor cells, or pluripotent stem cells to medical care providers needing such cells for advanced clinical trials and clinical practice of regenerative medicine and cellular therapy. Manufacturing processes must comply with current Good Manufacturing Practices (cGMP) and good tissue practices, and directly support commercialization of a stem cell product.
|| Description: ||Stem cells have the potential to have a dramatic impact in treating many diseases and injuries, including those for which regenerative medicine holds promise, such as massive tissue loss due to combat-related injury. Translating stem cell potential into clinical therapies is limited by current cell manufacturing technology, regulatory, and logistics hurdles. The intent of this work is to accelerate the innovation required to overcome barriers associated with bioprocessing, quality and performance measures, production scales, and regulatory compliance of allogeneic stem cell delivery to clinicians "off the shelf." This project should ultimately provide a high-capacity, cost effective and leap-ahead manufacturing process for stem cells having relevance to regenerative medicine (i.e., bone, cartilage, nerve, muscle, blood vessels, and fat). Both scale-up and scale-out approaches are viable.
|| ||PHASE I: Complete an Engineering Analysis that determines: how cost-effective manufacturing will occur (including process optimization), how quality, performance, and stability of selected cell line(s) will be ensured, the capital costs required for initial operation, and estimated cost of goods sold. Operations will include all steps from purchase of cell lines, selection or purification of cells, expansion/maintenance of cells (bioprocessing and cell banking), final packaging and labeling, quality controls (including in-process and release specifications), and shipping. All data used in this Engineering Analysis should be objective and science-based.
|| ||PHASE II: Using the results of Phase I, fabricate and demonstrate using at least 3 lots the consistent manufacture of either a scaled-up or scaled-out process. Manufacture of these lots must be acceptable to the US Food and Drug Administration as documented in a Drug/Biological/ Device Master file or other document that supports introduction of the cell product into an advanced (Phase II/III) clinical trial or preferably, into commercialization of the cell line.
|| ||PHASE III: The end-state of this research effort will be an "off-the-shelf", cost effective and FDA-approved manufacturing solution for delivering critical allogeneic stem cells to the medical care market, particularly for use in regenerative medicine applications. This outcome will support the US Army's Armed Forces Institute of Regenerative Medicine (AFIRM) objectives to clinically evaluate and translate into medicine innovative regenerative medicine technologies.
|| References: ||) Kirouac, Daniel C. and Zandstra, Peter W.; The Systematic Production of Cells for Cell Therapies; Cell Stem Cell 3: October 2008, pp 369 - 381.
2) Wargo, Sara; Russell, Alan J., and Holcomb, John B.; Military Needs and Solutions in Regenerative Medicine; Prin Regenerative Med, 2008, pp 1322-1332 (doi:10.1016/B978-012369410-2.50079-6)|
|Keywords: ||regenerative, medicine, stem,cell, allogeneic, cGMP, good tissue practices, bioprocessing, cellular, therapy, military, AFIRM, manufacturing technology, manufacturing productivity quality systems, |