University of Alberta - Advanced Contract Award Notice / Notice of Proposed Procurement - Flow Cytometer

Advance Contract Award Notice to purchase a Beckman Coulter Life Sciences manufactured CytoFlex LX NO-V5 Flow Cytometer for the Cross Cancer Institute. Cross Cancer Institute conducts research and development of a highly specialized autologous CART cells for clinical trials under stringent regulatory requirements set by Health Canada. The flow cytometry assays are uniquely designed for each project and product type and are used to test for identity, quality and efficacy of CART cells and developed during the product development stages of the project. The assay result must meet predetermined specifications before the product can be released to the patient. Considerable time and resources are used to set up these assays prior to the start of each clinical trial in order to qualify the assay using specific reagents and equipment and the sponsor approves the assay used in advance. Once developed, the assays used for product release testing is detailed in the Clinical Trial Application that is submitted to Health Canada . If any changes are made to these assays, a clinical trial amendment must be submitted to Health Canada. These assays are extremely time sensitive. Given the critical nature of our CAR-T product operations and the necessity for seamless testing processes, it is imperative to maintain equipment consistency and mitigate potential risks. The clinical nature of this production requires consistency or the process which can only be assured using equipment that has been approved for this specific trial.