The Institute for Bioscience and Biotechnology Research (IBBR) is seeking proposals to lease a biomanufacturing facility to produce biologics under cGMP conditions in compliance with FDA requirements for Phase I/II trials. The facility is also equipped to perform process development research, preclinical manufacturing for IND-enabling toxicology studies, Point of Concept (POC) studies, and process demonstration in advance of Good Manufacturing Practices (GMP) manufacturing. IBBR is a joint research enterprise between the University of Maryland and the National Institute of Standards and Technology.
 
IBBR is located northwest of Washington, DC, within reach of major academic, industry, and federal research labs, including University of Maryland campuses, NIST, NIH/NCI, FDA, and USDA. The GMP facility is located on IBBR’s campus at 9600 Gudelsky Drive, Rockville, MD 20850. IBBR is requesting proposals for review on a case-by-case basis until a preferable response is identified before September 30th, 2019.
 
Proposals will be evaluated based upon the following criteria:

• Qualifications of applicant and personnel to be engaged in manufacturing activities.
• Rental rate proposed to IBBR.
• Type of collaboration proposed (simple lease, revenue sharing, other).
• Use of facility, if necessary, for manufacturing clinical product candidates that might be developed by IBBR and the University of Maryland.
• Potential involvement with research and training and education programs currently conducted at the institute.