Biomanufacturing
High-quality biomanufacturing is crucial for preclinical cell therapy research and the translation of experimental cell therapy products into clinical trial-compliant medicines.
The Riddell Centre's Biomanufacturing Program enhances existing capabilities to support preclinical research and early-phase clinical trials. This program includes a dedicated Cell and Vector Process Development (PD) Laboratory, a Quality Control (QC) Laboratory, and a current Good Manufacturing Practice (cGMP) Cell Manufacturing Laboratory. Each facility is operated by a small, highly trained team of scientists and technicians, overseen by a dedicated Quality Assurance (QA) Program.
Process Development (PD) Laboratory
The PD Laboratory manufactures high-quality research and development-grade bioreagents and establishes cGMP-compliant processes for experimental cell therapy products in early-phase clinical trials. This includes producing quality-assured vectors, cells, and other bioreagents to support preclinical research, optimizing manufacturing for quality, efficiency, cost, and scalability, and developing cGMP-compliant manufacturing protocols, quality assurance systems, and control assays. Additionally, the laboratory supports regulatory filings to Health Canada with cGMP process development data, validated cell therapy product release assays, and stability testing programs.
Quality Control (QC) Laboratory
The QC Laboratory ensures the release of high-quality cell therapies by developing and implementing rigorous cGMP-compliant quality control assays and protocols. This includes establishing comprehensive testing procedures to monitor and verify product quality throughout manufacturing, storage, and release. The QC Laboratory also focuses on validating release assays, ensuring robust stability testing, and maintaining detailed documentation to support regulatory filings to Health Canada. By maintaining stringent quality standards, the QC Laboratory facilitates the reliable production and clinical application of safe and effective cell therapies.
Cell Manufacturing Laboratory
The Cell Manufacturing Laboratory will produce quality-assured experimental cell therapy products for early-phase clinical trials. This involves cGMP-compliant production, storage, and release of cell therapy products, ensuring they meet the highest quality standards to support successful early-phase clinical trials. We anticipate that the cGMP cell therapy lab will be constructed, commissioned, and operational by the end of 2025.
Quality Assurance (QA) Program
The Quality Assurance (QA) Program is integral to the success of the Biomanufacturing Program, ensuring adherence to cGMP standards across the PD Laboratory, QC Laboratory, and Cell Manufacturing Laboratory. Responsibilities include developing and implementing quality systems, conducting audits for compliance, overseeing validation and qualification processes, managing document control, and implementing risk management strategies. The QA team collaborates closely with all labs and regulatory agencies to ensure that experimental cell therapy products meet the highest quality standards for preclinical research and early-phase clinical trials, facilitating the safe and effective translation of bench-to-bedside therapies.
Our Biomanufacturing team is located in the Arthur J.E. Child Comprehensive Cancer Centre. For inquiries, please contact Dr. Kyle Potts, Associate Director of Biomanufacturing (kyle.potts@ucalgary.ca).
Biomanufacturing Team
Ann Nath
Associate Director of Quality Assurance
Dr. Nicole Prokopishyn
Special Advisor to the Riddell Centre, Director of Cellular Therapy Lab
Lindsey Suh
Cell Manufacturing Specialist
Chimdindu Ohaegbu
Process Development Specialist
