Tuesday, August 12, 2008 - 8:30 AM
S61

SIM 2008 Presentation – Daniel Kuebbing, Ph.D. – Interaction of Industry and Academia in Development of Early Phase Clinical Trial Materials

Daniel Kuebbing, UMBI GMP Training and Biomanufacturing Program, 9600 Gudelsky Drive, Rockville, MD 20850

The University of Maryland Biotechnology Institute has established a small scale GMP compliant biologics manufacturing facility at its Shady Grove campus.  The facility can produce biologics from cell culture or fermentation as well as nanoparticle products.  The mission of the GMP Program is to provide cost effective production of materials for early phase clinical trials.  The typical client is a small biotech company taking its first product to the clinic.  These clients often do not have experience in using a contract manufacturer or in GMP compliance.  Therefore, in addition to the transfer of technology from the client to the manufacturer, there is a need for both education on the requirements of compliance and for process changes to accommodate compliance as well as the increase in scale.  Examples of the interactions with clients will be presented.