24-58190 - Feasibility Study for Utilities and Ventilation Risk - Clinical Trial Material Facility

Feasibility Study for Utilities and Ventilation Risk Mitigation Services for a new Clinical Trial Manufacturing Facility .

The National Research Council of Canada is building a new Clinical Trial Manufacturing Facility (CTMF) that will house the process and equipment for the production and the quality control of protein, viral vector or virus-like particle vaccines or biologics. The products are mainly intended for the Canadian market, regulated by Health Canada under the authority of the Food and Drugs Act. The facility will require being compliant with Canadian Good Manufacturing Practices (GMP) as well as FDA current GMP (cGMP) and Eudralex requirements. The new manufacturing rooms and airlocks (personnel and material) will be built in an extension to the existing NRC’s premises located in Montreal, Quebec and will consist of classified grade C and D areas. The facility will include equipment and infrastructures necessary for viral seed stock preparation, subculture, cell culture and viral production, purification and warehousing. The facility was designed to operate under normal environmental condition and Hydro-Quebec power supply. As CTMF is ramping towards onboarding a client and initiate GMP production runs, several challenges have emerged impacting our utilities and ventilation.