The long-term objective for Core D, Product Development and Manufacturing (RDM) Core, is to facilitate the development of products by providing a regional resource for RMRCE investigators who are working on therapeutic, and vaccine technologies against the NIAID Category A-C Priority Pathogens or complimentary platforms. This Core addresses a critical barrier that prevents progress in the area of product translation by offering specific pre-good laboratory practice (GLP), GLP, and current good manufacturing practice (cGMP) services, resources, and training that act as a bridge over the notorious """"""""Valley of Death"""""""" spanning basic research to product commercialization. The PDM Core will accomplish this objective with three specific aims: 1) translate biological products from the RMRCE Product Pipeline;2) assist institutions in establishing GLP compliance for preclinical studies, and 3) develop an in-vitro drug susceptibility testing program for therapeutic candidates. Available support will encompass each of the three dimensions (safety, medical utility, and industrialization) identified in the Translational Critical Path described by the Food and Drug Administration (FDA). Specifically, services include: product development planning and monitoring, cell based assay development, process optimization and scale-up, stability testing, controlled documentation, invitro drug testing, reference lot preparation, GLP preclinical lot and cGMP clinical lot production, quality oversight for GLP and cGMP projects, IND application guidance, and various levels of training. Ultimately, the function of the PDM Core is to streamline the product development process by providing the missing link. Provision of PDM Core capabilities, facilities, resources and expertise will strengthen product profiles, leveraging industry or government interest to support late phase development. The outcome is a more effective, efficient, timely and less costly product moving into the public sector;a benefit to us all. Core D will support all three of the RMRCE Integrated Research Foci on Immunomodulation, Adjuvants and Vaccines (IRF 1), Bacterial Therapeutics (IRF 2), and Viral Therapeutics (IRF 3). Its resources will be utilized by RP 1.2, 1.4, 1.8, 2.3 and 3.6 as well as by CD 1 and 2.1.
The Product Development and Manufacturing Core will facilitate the development of products from basic research to the clinic, where they can then be tested for safety and efficacy in humans. By providing professional product development services and training, medical interventions will enter the national stockpile and/or the commercial marketplace more efficiently, more timely, and at a reduced cost.
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