SUPPLY ARRANGEMENT - LABORATORY ANALYSIS OF RAW MATERIALS AND FINISHED PRODUCTS (Stream 1,2 and,3)

Description

The objective of the project is to have tests carried out in accordance with Good Manufacturing Practices and current regulations (Health Canada, Food and Drug Administration (FDA), European Medicines Agency (EMA) for the analysis of raw materials, solutions, products, etc., in order to confirm the quality of our products. The National Research Council of Canada has built a new Clinical Trial Material 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 facility will require being compliant with Canadian Good Manufacturing Practices (GMP) as well as FDA current GMP (cGMP) and Eudralex requirements. This supply Arrangement includes 3 Streams (1,2,3) of services as follows: Stream 1 – Raw Material Analysis , Stream 2 – Various solutions, Biological products Analysis and Stream 3 – Cell Bank Characterization . See Statement of work for full details.