Rocky Mountain Regional Center of Excellence

Overview :

The overall objective for the Product Development and Manufacturing (PDM) Core is to provide infrasturcture and services to develop and manufacture vaccine, diagnostic and therapeutic products sufficient for preclinical and phase I/II clinical trials.

Product translation from the research bench to clinical trials will be coordinated by the Translational Development Subcommittee (TDS), comprised of the research investigator, the TDS Director, the PDM Core Project Leader, and experts in the specific product area, including regulatory affairs. 

Experienced PDM Core personnel will provide characterization of the potential product and optimization of the manufacturing processes and control assays under Good Laboratory Practice (GLP).  Individual services will also be available for various projects, specifically those which require Biosafety Level-3 containment. 

Upon successful completion of the product development phase, the PDM Core has the ability to manufacture products under current Good Manufacturing Practice (CGMP) for pre-clinical and early clinical studies.

Services are available to RMRCE, other RCE, and non-RCE researchers on a sliding fee-for-service basis. All prices listed are estimates for basic services and may differ depending on complexity of project.

Training:

The PDM Core also provides training modules for research investigators and career opportunities for senior trainees on RCE rotation interested in translational science.

Brochure
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Contacts:

Director and Manufacturing: Becky L. Rivoire, B.S., RAC
Co-Director and Process Development: Nathan A. Groathouse, M.S., RAC
Quality Control Manager: Deanna K. Scott, B.S., RAC
Quality Assurance Manager: Mary Sanders, M.S.
Quality Associate: Emily D. Stump, BS
Email: PDMCore@colostate.edu