The objectives of the Biomedicine Production Core (Applied Technology Core) are to facilitate the translational of bench-top research technologies into pilot-scale production and purification processes and to supply clinical biological material for use in human clinical trials. By providing these capabilities on campus, researchers are assured of complete oversight and control of the pre-clinical and clinical development of new therapeutic technologies and rapid movement of these technologies from the lab bench to the clinical setting.
The aims of this core are: 1) to complete process development of production and purification procedures for experimental technologies relating to viral and non-viral vector production, monoclonal antibody production and purification, Recombinant plasmid DNA production and hematopoietic cell engineering, 2) establish and maintain the necessary cell banks, plasmids DNA banks and helper viruses for use in product manufacturing, 3) establish in-house quality control systems to expedite product release, reduce overall contract assay costs and insure product safety, 4) manufacture suitable product material for Phase I and Phase II clinical trials, 5) develop and implement necessary document control, materials handling, personnel training and other support functions necessary to operate the facility in compliance with current Good Manufacturing Procedures. To achieve the above aims, a trained staff is being assembled with expertise in cGMP manufacturing of biologics, product development and regulatory affairs. The staff has significant collective expertise in the manufacture of viral and non-viral vectors, commercial production of monoclonal antibodies and manipulation of hematopoietic cells, including genetic engineering and expansion. Validation of the facility, processes and instrumentation is occurring throughout facility construction as outlined in an established Master Validation plan. Facility design and layout, and process, material and personnel flow through the facility have been reviewed by the teams from the Federal Food and Drug Administration and the California Food and Drug Branch. Process development is being performed in temporary facilities established in existing lab space in cooperation with individual Project Leaders and Directors. The Biomedicine Production Core will work with individual project leaders to provide regulatory assistance, develop production processes, generate supporting cell and DNA banks, perform all manufacturing and cell engineering and manage product release testing and represent the institution in interactions regarding manufacturing with the regulatory agencies.
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