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.

Public Health Relevance

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.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Specialized Center--Cooperative Agreements (U54)
Project #
5U54AI065357-09
Application #
8465816
Study Section
Special Emphasis Panel (ZAI1-DDS-M)
Project Start
Project End
Budget Start
2013-05-01
Budget End
2014-04-30
Support Year
9
Fiscal Year
2013
Total Cost
$261,172
Indirect Cost
$51,620
Name
Colorado State University-Fort Collins
Department
Type
DUNS #
785979618
City
Fort Collins
State
CO
Country
United States
Zip Code
80523
Gibson, Christopher C; Zhu, Weiquan; Davis, Chadwick T et al. (2015) Strategy for identifying repurposed drugs for the treatment of cerebral cavernous malformation. Circulation 131:289-99
Wang, Hong; Siddharthan, Venkatraman; Hall, Jeffery O et al. (2014) Autonomic deficit not the cause of death in West Nile virus neurological disease. Clin Auton Res 24:15-23
Scharton, Dionna; Bailey, Kevin W; Vest, Zachary et al. (2014) Favipiravir (T-705) protects against peracute Rift Valley fever virus infection and reduces delayed-onset neurologic disease observed with ribavirin treatment. Antiviral Res 104:84-92
Shives, Katherine D; Beatman, Erica L; Chamanian, Mastooreh et al. (2014) West nile virus-induced activation of mammalian target of rapamycin complex 1 supports viral growth and viral protein expression. J Virol 88:9458-71
Calvert, Amanda E; Dixon, Kandice L; Delorey, Mark J et al. (2014) Development of a small animal peripheral challenge model of Japanese encephalitis virus using interferon deficient AG129 mice and the SA14-14-2 vaccine virus strain. Vaccine 32:258-64
Richert, Laura E; Rynda-Apple, Agnieszka; Harmsen, Ann L et al. (2014) CD11cýýý cells primed with unrelated antigens facilitate an accelerated immune response to influenza virus in mice. Eur J Immunol 44:397-408
Soffler, Carl; Bosco-Lauth, Angela M; Aboellail, Tawfik A et al. (2014) Pathogenesis of percutaneous infection of goats with Burkholderia pseudomallei: clinical, pathologic, and immunological responses in chronic melioidosis. Int J Exp Pathol 95:101-19
Porta, Jason; Jose, Joyce; Roehrig, John T et al. (2014) Locking and blocking the viral landscape of an alphavirus with neutralizing antibodies. J Virol 88:9616-23
Jones-Carson, Jessica; Zweifel, Adrienne E; Tapscott, Timothy et al. (2014) Nitric oxide from IFN?-primed macrophages modulates the antimicrobial activity of ?-lactams against the intracellular pathogens Burkholderia pseudomallei and Nontyphoidal Salmonella. PLoS Negl Trop Dis 8:e3079
Phillips, Aaron T; Schountz, Tony; Toth, Ann M et al. (2014) Liposome-antigen-nucleic acid complexes protect mice from lethal challenge with western and eastern equine encephalitis viruses. J Virol 88:1771-80

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