ROCKVILLE, Md., March 7, 2016 /PRNewswire-USNewswire/ — 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. The deadline for submitting proposals is April 15th 2016.
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 theUniversity 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.
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