GMP Feasibility Study

Tender description

The School of Pharmacy, Cardiff University, wishes to appoint a contractor to undertake a specialist evaluation and feasibility study of Cardiff University Redwood Building currently unlicenced Good Manufacturing Practice (GMP) suite for adaptation and recommissioning for alternative use. The successful Bidder will be required to conduct a feasibility study for change of use of an existing cleanroom for manufacture of GMP-compliant advanced therapies (cell and gene therapies). The existing cleanroom was built in 2010 according to MHRA specifications to enable small scale development of pharmaceutics, process optimization and product development. The unit is split into two areas, each with their own designated change facility: a pharmaceutical grade area and a grade B sterile production area. The 106m2 EU GMP Class B/ISO 14644-1 Class 5 floor space currently contains four double glove, rigid positive pressure Class A Isolators, a horizontal Laminar Air Flow Cabinet, and a negative pressure 4 glove hazardous products isolator. The unit also provides 45m2 of unclassified production space, with an adjoining preparation room, a microbiology facility with Class II safety cabinet and non-pharmaceutical autoclaves. Intended use: The facility is intended to be modified as a translational GMP Facility that will function as a versatile platform for developing clinically applicable cell and gene therapies for cancer, neurodegenerative and other diseases and for regenerative medicine products.