Feasibility Study for Fill / Finish, Cryo-storage and Packaging room construction and qualification for a new Clinical Trial Manufacturing Facility (CTMF)

Fill and Finish Process The objectives of the feasibility study are to determine the cost and timeline to design, build and qualify a cleanroom for fill finish. The room will host a modular filling and lyophilization line to fill and freeze dry. In addition, the room will include a single door autoclave to sterilize re-usable components. The room will be designed to meet class C. Secondary Packaging Process The objectives of the feasibility study are to determine the cost and timeline to design, build and qualify a packaging hall to perform particle inspection, to detect glass integrity and secondary packaging (labeling, cartoning, bundling, check weighing, case packing and palletizing). The room will host an inspection machine and a modular packaging line. The room will be designed to meet CNC. Cryo-storage The objectives of the feasibility study are to determine the cost and timeline to design, build and qualify a storage room to host 4 freezers, 4 cryo-freezers and 1 refrigerator. The room will be designed to supply nitrogen for the cryo-freeze and a miniature warehouse racking. The room is designed to be NC. Network Infrastructure The objectives of the feasibility study are to determine the cost and timeline to design, build and qualify a new program application and infrastructure to the existing infrastructure. The infrastructure will include integration of NAV ERP, LIMS, MES, QMS, MIT, GS1, CPM, EMS, IMS and DBMS.