The Biologics Manufacturing core for this SPORE application is dedicated to the production of clinical trial materials according to programmatic requirements outlines in the individual projects and all applicable state, local and Federal regulations for investigational products. The core is divided into three production groups; cell products, monoclonal antibodies and viral vectors. Each group is led by a Director with extensive experience in the production of clinical trials materials and Good Manufacturing Practices (GMP). Each group is supported by a Quality Systems Team (Quality Assurance and Quality Control) that ensures that testing and documentation of investigational product manufacturing is performed according to the applicable regulations. Manufacturing will occur at two sites. The Center for Biomedicine and Genetics (CBG) and the Laboratory for Cellular Medicine (LCM) manufacturing facility in the new Arnold and Mabel Beckman Center for Cancer Immunotherapeutics and Tumor Immunology completed in 2009. Monoclonal antibodies and constructs for Projects 1, 3 and 4 and Viral vectors for Project 1 will be manufactured in the CBG while cell products for Project 1 will be manufactured in the LCM. Over the past five years monoclonal antibody products have been produced for the previous SPORE Projects 1,2,4 and 5, some of which have been used in clinical trials. Extensive development of manufacturing, conjugating and vialing procedures for MAb products has taken place. A new method for the conjugation of MAbs at clinical scale quantities has been developed and recently published. The Laboratory for Cellular Medicine (LCM) has manufactured products for the previous iteration of SPORE Project 2 (Adoptive Immunotherapy for Follicular Lymphoma), is currently manufacturing products for Mantle Cell/DLBC Lymphoma (Project 1). Extensive process development has taken place in the areas of closed system cell processing, cell selection, lentiviral-based genetic modification and expansion in preparation for manufacturing investigational cell products for Lymphoma and other hematological malignancies. Plasmid DNA and Viral vectors have been manufactured for Follicular Lymphoma and Mantle Cell/DLBC Lymphoma protocols and are currently being developed for treating NHL patients for SPORE Project 1.
The Biologics Manufacturing Core is dedicated to the production of clinical materials described in this application. Manufacturing is performed in two fully GMP compliant manufacturing facilities on the campus of City of Hope. Each product type (monoclonal antibodies, cell products and viral vectors) is manufactured by a team of trained professionals who ensure the product meets the purity, potency, identity and safety requirements established by Federal regulations.
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