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• W2340087665 abstract "Blood establishments in the United States are experiencing market conditions common to virtually all businesses but which are relatively novel to the nearly seven decades of United States blood banking. Historically, blood has been a scarce commodity and all resources were focused on simply increasing collections to meet an ever-increasing demand. Beginning several years ago, US blood consumption began to decrease and the resultant relative oversupply triggered concomitant pressure to decrease the price of blood components. Simultaneous sweeping changes in healthcare reimbursement and the subsequent hospital customer focus on cost containment through patient blood management further exacerbated market conditions and accelerated both decreased demand and pressures to reduce blood prices. To deal with these market changes, most blood collectors have sought mergers or have engaged in novel affiliations to reduce operating expenses and increase efficiency. Others, not unlike Blood Systems, have diversified into donor testing, patient testing, centralized transfusion services, marrow processing to support transplants, computer system development, and other related products and services. Downward price pressure and shrinking sales volumes have combined to create an uncertainty that has cleared the way for different thinking about organizations’ long-term strategy in an increasingly commoditized market. The growth in the regenerative medicine market has provided one such avenue for Blood Systems and others to rethink their longer-term strategy and vision. Where the organizations’ core competencies still lie in the collection, processing, testing and distribution of blood, blood components and derivative biologics, the advancements in regenerative therapies and personalized medicine, involving both autologous and allogeneic therapies, present opportunities to consider new products and channels. Blood Systems believes that the vertical integration of processes to safely manufacture cellular products is present at blood establishments. Donor qualification, raw material sourcing, manufacturing, storage, distribution, adverse reaction reporting, and all steps in between provide for potentially complete vertical integration to prospective customers and has two distinct advantages. First, it presents a ready-made package for potentially “vein-to-vein” manufacturing; second, and most importantly, it provides an opportunity to impact multiple points in the value chain to increase the value proposition to potential clients. Blood establishments, given their extensive experience in the compliant manufacture of blood and blood components, are uniquely positioned to leverage this experience to participate in the manufacture of novel cell therapies. One obvious opportunity, in which many blood establishments already engage, is the compliant qualification, sourcing, and collection of raw materials (typically autologous mononuclear cells to date) for cellular vaccine manufacture. These opportunities will likely continue to increase in the near- to mid-term, but it is clear that, eventually, the goal of cell therapy development companies will be to manufacture their therapies at the patient bedside in a fashion similar to the way extracorporeal photopheresis is performed today. The obvious difference will be the application of a different and likely more targeted method to manipulate the collected cell population. Manufacturing new cell therapies will leverage blood establishments’ strengths while providing the value inherent in contract manufacturing organizations such as spreading capital and other expenses over a broad range of products and speeding time to market by already having facilities, trained staff, and GMP/GTP infrastructure among others. As these attributes are most valuable early in cell therapy development (and for additional reasons to be discussed later) it is important that blood centers leverage the strong relationships they have with academic institutions, researchers, and start-up cell therapy companies. A way Blood Systems sees that blood establishments can embed themselves is to provide raw materials to researchers and biotech companies such as buffy coats, white blood cells from filters, leukoreduction chambers, and platelets (PLTs). Other blood center–based products such as cryoprecipitate, human PLT lysate, and fresh-frozen plasma may be used in the manufacture of cell therapies and present additional opportunities to generate revenue from by-products of typical blood component production. Blood Systems additionally recognizes an opportunity for blood establishments to demonstrate their ability to manufacture novel cell therapies through allogeneic human marrow-derived mesenchymal stromal cells (BM-hMSCs). BM-hMSCs specifically have been shown to differentiate into skeletal tissues such as cartilage cells (chondrocytes), bone cells (osteoblasts), and fat cells (adipocytes). They have a unique characteristic in that they lack virtually all HLA antigens and, therefore, are believed to largely escape the host's immune response; thus, matching is not required for administration. More than 300 clinical trials have so far demonstrated remarkable safety and strong indications of the efficacy of both allogeneic and autologous BM-hMSCs for a wide variety of clinical conditions. At present, the demand for clinical-grade BM-hMSCs for use in clinical trials currently exceeds supply. For a blood establishment, their safety, universal application with respect to host, ease of expansion, and potential efficacy make them ideally suited for manufacture. Despite the increasing momentum toward regenerative therapies using stem cells and the relative strengths in GMP that blood centers possess, the Blood Systems experience could signal that blood establishments may not possess all of the necessary infrastructure to fully engage in the manufacture of novel cell therapies. Based on the Blood Systems experience, shortcomings for blood establishments as manufacturers of novel cellular therapeutics include clean room facilities, scientific and technical expertise with experimental cell manipulations, and regulatory functions. In developing the BM-hMSC expansion program at Blood Systems, we have addressed these shortcomings in varying ways. Technology to overcome the need for clean room facilities typical of the flask-based expansion of BM-hMSCs is currently available. One such bioreactor device, the functionally closed, continuously monitored, hollow-fiber Terumo Quantum Expansion device negates the need for a clean room for expansion. Each passage requires approximately 8 hours of labor for the entire 7- to 10-day expansion time. Several studies have documented the in vitro bioequivalence of hollow fiber–expanded BM-hMSCs to flask-based expansion methods, so Blood Systems was comfortable in selecting the device. Postexpansion processing (washing, concentrating, and preparing for cryopreservation) of the BM-hMSCs required some engineering, as these steps are typically carried out in a clean room environment. Currently, since no cost-effective functionally closed system is readily available, Blood Systems developed processes utilizing equipment already available in its marrow processing laboratory. Specifically, the laboratory utilized the BioSafe Sepax 2 with a 600.1 disposable set and a modified cell wash protocol to wash and concentrate the cells, followed by a modified dilution protocol to add the cryoprotectant. This functionally closed process produces acceptable wash efficiency and minimal cell aggregation. Two new containers, the OrigenCryostor multichamber bag or Cook RegentecCellSeal ease the ability to aliquot for cell banks in a functionally closed system. The laboratory also utilized the Fresenius LOVO for postexpansion washing with excellent removal of fetal bovine serum and the cell detachment agent and minimal cell activation or aggregation. However, challenges exist in concentrating the final cell volume and we continue to work with Fresenius on mitigation strategies. Finally, GMP-grade reagents, media, and cryoprotectants are readily available and negate the need for manufacturing reagents. Scientific expertise within the BM-hMSC manufacturing program has been provided by the scientists at Blood Systems Research Institute (BSRI) in San Francisco, California. BSRI scientists have considerable expertise with MSCs and with the Quantum Expansion Device, and it is at BSRI that processes were developed and optimized. The validated procedures then pass to Blood Systems Laboratories in Tempe, Arizona, for final optimization and integration into the organization's GMP program. This division of labor has worked well for Blood Systems. Other blood establishments could collaborate with researchers in other academic centers for that same, necessary expertise. Blood establishments’ regulatory expertise typically does not extend into the areas required to manufacture novel cellular therapies, and this has been true for Blood Systems as well. The team overcame this hurdle by pooling knowledge from its various operating divisions and supplementation with external consultants, as necessary. By combining the collective knowledge from multiple operating divisions within Blood Systems (BSRI, Blood Centers Division, BioCARE [blood derivative/pharmacy] division, marrow transplant processing laboratory, and our internal clinical trials review group), we found that we had a strong foundation to build our activities beyond those of blood component manufacture. Areas that required supplementary expertise included writing drug master files, chemistry, and manufacturing control documents and working with researchers on grants and investigational new drug applications. Blood establishments have unique skills and expertise that will allow them to participate in market activities that extend beyond those typically associated with blood components but the endeavor requires accepting some level of risk. The extent to which blood establishments wish to participate determines, in large part, the amount of investment they will have to make to be successful and the level of risk they decide to undertake. At Blood Systems, the desire to participate in the manufacture of novel cell therapies has resulted in significant investment in our financial, personnel development, and scientific resources. It also required substantial and novel partnerships with industry, both within and beyond the blood banking community. As scientific and technologic advances in cell expansion and manipulation are significantly easing market entry, Blood Systems looks to lead the industry's foray into the regenerative medicine market. The author is an employee of Blood Systems." @default.
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• W2340087665 title "Redefining the role of blood establishments as raw material suppliers, manufacturers, and distributors for new cell therapies: the Blood Systems experience" @default.
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