Product Development and Manufacturing Core

Overview: The Product Development and Manufacturing (PDM) Core, part of Biopharmaceutical Manufacturing and Academic Resource Center (BioMARC), offers product translational services to academic, government, and industry partners for the development and manufacture of vaccines, therapeutics, and diagnostics used in preclinical animal studies and phase I and II human clinical trials. Specialized services include projects that involve Biological Safety Level 2 and 3 pathogens, and/or HHS/CDC category A-C select agents.

Product Development: The PDM Core’s Product Development Department provides preliminary product characterization and formulation, process scale-up and optimization, small-scale bioprocessing, reference lot preparation, and assay development in a laboratory compliant with FDA Good Laboratory Practice (GLP) regulations. Preparation of GLP preclinical grade material is also available.

Manufacturing: The Manufacturing Department within the PDM Core performs product manufacturing that is compliant with FDA current Good Manufacturing Practice (cGMP) regulations for early-phase clinical studies. Documentation is established for each project, including raw material specification sheets, batch records and supporting standard operating procedures (SOP). Facilities are commissioned, environmentally tested, and released for each manufacturing campaign. Final product can be stored short-term under controlled conditions. 

Quality: The PDM Core’s Quality System, maintained by the Quality Control and Quality Assurance Departments, provides testing, validation, and auditing for GLP and cGMP-compliant projects, as required by the Code of Federal Regulations. Product release testing of manufactured products, including safety, stability, purity, potency, identity, and sterility testing, is performed as per the United States Pharmacopeia (USP), where applicable. Procedural validation is performed by documentation review and systematic inspections. Auditing services for GLP projects are available for outside projects.

Consultation: Discussion of regulatory needs and guidance with FDA and ICH regulations and documentation are available.

Training: The PDM Core currently provides training modules and seminars for research investigators and career opportunities for senior trainees on RCE rotation who are interested in translational science. Over the next year, The Product Translation Training Center, a subsidiary of the PDM Core, will offer three short courses covering key topics in product translation. These courses will be offered by professionals in the field.

Fees for Service: PDM Core services are offered to RMRCE, other RCE, and non-RCE investigators on a sliding fee-for-service basis. Project costs may vary depending on complexity of project.

 

Personnel:
Director: Dennis Pierro, RAC, Ph.D.
Manufacturing: Suresh Bhamidi, Ph.D.
Process Development: Darragh Heaslip, Ph.D.
Quality Control: Katrina A. Quinn, M.S.
Quality Assurance: Celeste O'Connor, B.S. and Trisha Martin
Raw Materials: Kathryn Knopinski, B.S.


Contact Information:
The Product Development & Manufacturing (PDM) Core
Rocky Mountain Regional Center of Excellence
Colorado State University
2025 Campus Delivery, Fort Collins, CO 80523
Phone:(970) 491-8954, Fax:(970) 491-8708


Email: PDMCore@colostate.edu