Product Development and Manufacturing (PDM) Core

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Introduction: Challenges in translational research will affect many viral, bacteriological, and proteomics/genomics investigators within the Regional Center of Excellence (RCE), who are intent on moving a potential product into clinical trials. The overall objective for Core B, Product Development and Manufacturing (RDM) Core, is to address these challenges by providing the capacity to develop and manufacture vaccine, diagnostic, and therapeutic products sufficient for Phase I and II clinical trials. Specific aims for the RDM Core include: (1) coordinate and prioritize product translation from the research bench to clinical trials with the Translational Development Subcommittee (TDS), (2) provide Good Laboratory Practice (GLP) pre-clinical development for products arising from the various projects of RCE and non-RCE investigators, including those which need Biosafety Level 3 containment, (3) optimize and validate the manufacturing process, equipment, and control assays, (4) manufacture products under current Good Manufacturing Practice (cGMP) for pre-clinical and early clinical studies, and, (5) develop career opportunities for senior trainees on RCE rotations. The research design for product translation will vary between products, depending upon direction provided by the research investigator and the TDS. Core personnel will have experience in culturing, fractionating, purifying, analyzing, and cloning to allow for smooth product transition from the research group to the core group. Upon successful completion of product development, clinical grade material will be manufactured under cGMP in the existing pilot plant located in the Microbiology Building on the CSU main campus, or in the Regional Biocontainment Laboratory (RBL) to be constructed at the CSU Foothills campus. Quality control testing for integrity, stability, sterility, potency, safety, and purity, as required by the Code of Federal Regulations, Title 21, will be performed in an adjacent QC unit. The RDM Core infrastructure will provide a medium within the RCE to move a product from basic research to applied research. The use of human subjects to evaluate the safety and efficacy of these products in early clinical trials will follow as outlined by the investigator, and approved by regulatory authorities. Project Interactions: The PDM Core (Core B), will have extensive interactions with RCE Spores, Pores, and other Cores through the organizational structure of the TDS. Additional interactions with investigators outside of the RCE (either on-campus or off-campus, non-profit or for-profit) may occur, on a fee for service basis, until RCE research products are ready to be moved into the PDM Core.