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.

National Institute of Health (NIH)
National Institute of Allergy and Infectious Diseases (NIAID)
Specialized Center--Cooperative Agreements (U54)
Project #
Application #
Study Section
Special Emphasis Panel (ZAI1-DDS-M)
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Colorado State University-Fort Collins
Fort Collins
United States
Zip Code
Webb, Jessica R; Price, Erin P; Somprasong, Nawarat et al. (2018) Development and validation of a triplex quantitative real-time PCR assay to detect efflux pump-mediated antibiotic resistance in Burkholderia pseudomallei. Future Microbiol 13:1403-1418
York, Joanne; Nunberg, Jack H (2018) A Cell-Cell Fusion Assay to Assess Arenavirus Envelope Glycoprotein Membrane-Fusion Activity. Methods Mol Biol 1604:157-167
Rhodes, Katherine A; Somprasong, Nawarat; Podnecky, Nicole L et al. (2018) Molecular determinants of Burkholderia pseudomallei BpeEF-OprC efflux pump expression. Microbiology 164:1156-1167
Cummings, Jason E; Slayden, Richard A (2017) Transient In Vivo Resistance Mechanisms of Burkholderia pseudomallei to Ceftazidime and Molecular Markers for Monitoring Treatment Response. PLoS Negl Trop Dis 11:e0005209
Pettey, W B P; Carter, M E; Toth, D J A et al. (2017) Constructing Ebola transmission chains from West Africa and estimating model parameters using internet sources. Epidemiol Infect 145:1993-2002
Furuta, Yousuke; Komeno, Takashi; Nakamura, Takaaki (2017) Favipiravir (T-705), a broad spectrum inhibitor of viral RNA polymerase. Proc Jpn Acad Ser B Phys Biol Sci 93:449-463
Skyberg, Jerod A; Lacey, Carolyn A (2017) Hematopoietic MyD88 and IL-18 are essential for IFN-?-dependent restriction of type A Francisella tularensis infection. J Leukoc Biol 102:1441-1450
Plumley, Brooke A; Martin, Kevin H; Borlee, Grace I et al. (2017) Thermoregulation of Biofilm Formation in Burkholderia pseudomallei Is Disrupted by Mutation of a Putative Diguanylate Cyclase. J Bacteriol 199:
Randall, Linnell B; Georgi, Enrico; Genzel, Gelimer H et al. (2017) Finafloxacin overcomes Burkholderia pseudomallei efflux-mediated fluoroquinolone resistance. J Antimicrob Chemother 72:1258-1260
Podnecky, Nicole L; Rhodes, Katherine A; Mima, Takehiko et al. (2017) Mechanisms of Resistance to Folate Pathway Inhibitors in Burkholderia pseudomallei: Deviation from the Norm. MBio 8:

Showing the most recent 10 out of 258 publications