The Institute for Bioscience and Biotechnology Research (IBBR) is interested in proposals to lease a bio-manufacturing facility configured to produce biologicals under cGMP conditions in compliance with FDA requirements for phase I/II clinical trials. The facility is also equipped to perform process development research, preclinical manufacturing for material necessary for IND-enabling toxicology studies, Point of Concept (POC) studies, and process demonstration in advance of GMP manufacturing. The Good Manufacturing Practices (GMP) facility is located on the University of Maryland's Shady Grove campus at 9600 Gudelsky Drive, Rockville, MD 20850.
IBBR is a University System of Maryland joint research enterprise between the University of Maryland College Park, The University of Maryland Baltimore and the National Institute of Standards and Technology.
IBBR is requesting proposals for review on a case-by-case basis until a preferable and credible response is identified at the conclusion of this RFP.
Proposals will be evaluated based upon the following criteria:
- Qualifications of applicant and personnel to be engaged in manufacturing activities
- Rental rate proposed
- Type of collaboration proposed (simple lease, revenue sharing, other)
- Use of facility, if necessary, for IBBR for manufacturing clinical product candidates that might be developed by IBBR and the University of Maryland.
- Potential fit with research that is currently being conducted at the institute. Please visit www.ibbr.umd.edu for more information on research areas of focus.
In addition, IBBR will consider proposals favorably based on projected economic development impact, community benefit, research collaboration with IBBR and the University, quality and nature of any proposed capital improvements to the GMP facility as well as other factors whereby the successful applicant's use of the GMP facility supports the University of Maryland's educational and economic development mission. IBBR reserves the right to not select any proposal.
Facilities and Services Available:
- Approximately 9,100 square feet of GMP suite, support areas, laboratory space, and offices.
- Designed and configured for bacterial or yeast fermentation and mammalian cell culture to manufacture products such as therapeutic proteins, monoclonal antibodies, vaccines, cytokines, DNA plasmid vaccines, viable cells for cell therapy, or nanotechnology based products.
- Flexible configuration that can be modified as per specific needs of the applicant
- Infrastructure support such as utilities, maintenance contracts, and facilities management.
Proposals should include:
- Electronic PDF submission of proposal.
- Lease amount inclusive of utilities per square foot per annum.
- Financials regarding other types of collaborations (if applicable) including revenue forecasts
- Proposed use of the facility.
- Economic Development Impact (i.e. relocating or creating jobs in the area).
- Preference for the manufacture of product candidates developed by IBBR and University of Maryland.
- Other factors related to IBBR’s scientific mission and vision
- All costs, proposed investments, contributions, and financial expectations related to the proposal should be outlined.
- Upon identification of a satisfactory proposal, the parties will develop a lease reflecting the terms of the proposal.
- Total lease term not to exceed 10 years including renewals.
- All information related to this RFP and submitted by applicants will be strictly confidential
Tours of the GMP facility can be scheduled and additional information can be obtained by contacting:
9600 Gudelsky Drive
Rockville, MD 20850