CORE: Cell Processing and Vector Production Shared Resource (Clinical Focus Group) PROJECT SUMMARY Cellular and gene therapies are finding more widespread use in the treatment of leukemias and solid tumors, and in repairing tissues that have been damaged by these diseases.The number of Phase 1 cell and gene therapy Investigational New Drug applications (INDs) submitted to the Food and Drug Administration (FDA) has undergone exponential growth. A potential barrier to conducting such studies is the FDA requirement that these biological drugs must be manufactured under current Good Manufacturing Practices (GMP) regulations. These provide a highly documented framework that specifies the conditions for manufacturing, testing, releasing and distributing the therapeutic product. The Cell Processing and Vector Production Shared Resource at the Baylor Center for Cell and Gene Therapies provides Dan L. Duncan Cancer Center (DLDCC) investigators with access to a highly experienced, state-of-the-art GMP facility consisting of 22 manufacturing clean rooms, product analytical services, and Quality Control laboratories and Quality Assurance services. In addition, the GMP staff have extensive experience manufacturing a wide range of cellular products and viral vectors. They are also very familiar with the submission of regulatory documents to support IND applications. This resource can speed the transition of cellular and gene therapy products from the basic science laboratory into early-phase clinical trials. Traditionally this translational step has been a major impediment to starting IND studies. Staff of this DLDCC resource will work with investigators to develop clinical scale manufacturing procedures, release test specifications, testing procedures, quality assurance oversight, and regulatory assistance to assist in IND submissions. They will then provide both the clinical products for the trial, and summary data for annual reports. This service places DLDCC researchers at a distinct advantage when transitioning from research studies to clinical trials.
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