2025RFQ0001 - GemCell Human Serum

The University of Calgary (UCalgary) is looking for a supplier to provide the GemCell™ Plus Xeno-free Human Serum (AB Serotype) and GemCell™ U.S. Origin Human Serum (AB Serotype).  The GemCell™ Human Serum is a critical component in the validated processes supporting UCalgary Riddell Centre for Cancer Immunotherapy’s CAR T cell manufacturing program and Clinical Trial Application (CTA) to Health Canada. This specific serum lot has been used extensively in the lab for validation work, and its characteristics ensure it meets the stringent requirements for clinical-grade applications. Regulatory guidelines mandate the continued use of the same lot of serum during the clinical trial to maintain consistency and alignment with the data submitted in the CTA. Any deviation, such as switching to a different lot or product, would require revalidation to confirm comparability, resulting in significant delays, additional costs, and potential risks to the integrity of the clinical trial.