The Human Applications Laboratory is a state of the art GMP manufacturing facility that occupies 2200 sq ftin the McKnight Brain Institute. The unit includes an 1800 sq ft BL2/BL3 GMP facility, a 300 sq ft Quality Control laboratory and storage facilities for receipt and control of incoming materials.
The GMP manufacturing facility has two suites with 2 production modules in each module which operate on a campaign basis. The first suite deals with Cell Processing and the other is used for Viral Vector Production. The facility director is Brian Cleaver, Ph.D.
- Priority will be given to extramurally sponsored projects at the University of Florida.
- Excess production capacity will be used to accommodate requests from outside investigators.
- Clinical trial protocol approval by the NIH Recombinant DNA Advisory Committee (RAC) is required prior to requesting services from the UF Human Applications Laboratory.
Brian D. Cleaver, Ph.D.
Associate Director, PGTC
Director Human Applications Lab
Dr. Brian Cleaver obtained his B.S., M.S. and PhD degrees from the University of Florida. After spending six years in the biotech industry, he returned to the University of Florida in 2002 and is now the Associate Director of Operations in the Powell Gene Therapy Center.
Dr. Cleaver was one of the original members that developed the Quality Assurance Unit in the Powell Gene Therapy Center. He managed all preclinical GLP Quality Assurance from 2002 to 2004. In 2004 he took over as the Operations Director in the Human Applications Laboratory and has directed GMP Operations since that time. He has over twenty years of experience in the development of biopharmaceuticals from the research and development, to preclinical toxicology testing, GMP clinical manufacturing and testing, and clinical trial development and execution. This includes extensive experience with Local, State, Federal and International Regulatory Agencies.
- Jenna Ross
- Brandie Shaw