The University of Florida made a major commitment to furthering the growth of biotechnology in the state through the creation of a Center of Excellence for Regenerative Health Biotechnology (CERHB).
The aim of the CERHB is to discover and commercialize new therapeutics for human disease. To do this, the University of Florida embarked on the renovation of an existing 22,000-sq-ft campus facility to comply with cGMPs.
Biomanufacturing requirements included cellculture, production harvest, purification (two suites) and formulation, and fill finish. Cold storage systems for quarantine and release were part of the raw materials quarantine area.
Support labs included QC chemistry, QC microbiology and an instrumentation lab. Each area was segregated for compliance for its own fill/finish and separate sterility suites for aseptic manufacturing (filling and lyophilization).
Utilities include reverse osmosis for USP purified water, as well as autoclaves used to decontaminate medical waste. Strict adherence to best design practices for clean rooms ensured that all materials, finishes, fixtures and devices are cGMP compliant.
A key challenge was the design and construction of a new structure to support roof-mounted air handling units.
The project also required complete commissioning/start-up services for various systems, including air handling unites (AHUs), boilers and distribution systems in order to balance and validate the new systems with the existing systems. |
