Baxter Healthcare Corp. announced Tuesday that it has entered intoseparate agreements with the National Institutes of Health (NIH) andthe University of Minnesota Health System (UMHS) to develop state-of-the-art cell processing centers at each facility.Baxter (NYSE:BAX) hopes to combine its manufacturing know-howwith the basic science expertise of the research institutions so that newcellular therapies can move swiftly from the lab into clinical trials.Under the terms of the three-year agreement with NIH's Department ofTransfusion Medicine (DTM) at the Warren G. Magnuson ClinicalCenter, Baxter will provide equipment, materials, technical assistanceand funding for the general operation of the cell-processing laboratory.In return, Baxter will have the right to participate in research that'sconducted in the lab and has the first option on commercializingdevelopments or inventions produced by the lab. NIH will receive aroyalty on products that are jointly developed.The cell-processing center will be located in an existing building on theNIH campus in Bethesda, Md. It may be used by researchers in any ofNIH's institutes who are working on the development of cellulartherapies, eliminating potential duplication and fragmentation ofresources, said Harvey Klein, who heads the DTM. In 1990 the DTMparticipated with other NIH institutes in the nation's first gene therapytrial."The advantage to NIH is that Baxter is a commercial manufacturerand has a great deal of expertise in processing cells and scaling up.Baxter also has the capability to manufacture products in accordancewith FDA's Good Manufacturing Practice standards," Klein said. "Italso has investigational activities with bone marrow and gene therapythat come from their commercial interests and dovetail with ours. Wewill be using some of the equipment that Baxter manufactures and[other] equipment they are developing. We see this as a technologytransfer using what a large commercial biotech industry does well andtaking some of the basic science expertise in the NIH and bringingthem to the bedside."According to the terms of their Cooperative Research andDevelopment Agreement (CRADA), Baxter and DTM will collaboratein developing and improving procedures for collecting, storing andexpanding ex-vivo manipulation of human cellular components. Insome cases, a completely new kind of modified cell may be developed,Klein noted.One way Baxter will help NIH is in the development of adocumentation system for cell processing, said Teresa Comiskey,Baxter's director of business development.She added that cellular therapies have potential applications in allforms of cancer, including lymphomas and leukemia, autoimmunediseases and genetic diseases."By the time the agreement expires in four years, we will know howand where cell processing is best performed, whether in a hospitalsetting or freestanding lab, and what kinds of control of the process areneeded to guarantee safe and effective therapy," Klein said.Baxter's collaboration with UMHS will be for three years. UMHS hashad a cell-processing facility for many years and since 1979 has beenprocessing blood products needed for bone marrow therapy in patientsat the university's hospital, according to Mary Clay, administrativescientist at UMHS's Department of Laboratory Medicine andPathology. She said Baxter would provide resources and equipment tosupport research studies for the development of new blood productsand optimization of blood cell processing techniques to support thehospitals' protocols for patients undergoing hematopoietic stem-celltransplantation, immunotherapy or gene therapy."These clinical protocols require large volumes of cells that have beenisolated or produced to provide specific therapeutic benefits such as thereconstitution of bone marrow with hematopoietic stem cells or theelimination of cancerous cells by tumor-killing cells," Clay said.Clay said Baxter will be able to learn from UMHS's experience how togo about financing and developing a cell-processing facility. She alsoviews the activities of NIH and UMHS as complementary. Forexample, she noted that both parties will share UMHS's dedicatedlaboratory data information services system to support the developmentof documentation protocols for blood cell processing activities."We will focus on the initial stages of taking the science and moving itinto a clinical laboratory setting, while NIH will go very quickly to alevel covered by FDA regulations for somatic cell therapy," she said.
-- Philippa Maister
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