Cell Manufacturing & Scale-Up

Cell Manufacturing & Scale-Up

Cell Manufacturing & Scale-Up

Cell Manufacturing & Scale-Up

Decorative shape

As regenerative medicine advances from laboratory discovery to clinical reality, one of the most critical challenges facing the field is the ability to manufacture cell-based therapies safely, reliably, and at scale. Producing billions of high-quality cells that meet stringent safety standards requires sophisticated bioprocessing technologies, rigorous quality control, and innovative solutions to problems that don’t exist in traditional drug manufacturing.

Canadian researchers are tackling key obstacles in cell manufacturing—from preventing harmful genetic mutations during large-scale cell expansion to developing safer methods for preserving and storing therapeutic cells. These technical innovations are essential for transforming promising stem cell therapies into accessible treatments that can reach patients across the country and around the world.

The work being done in this area doesn’t just advance scientific knowledge—it builds the foundation for a robust Canadian regenerative medicine industry capable of delivering safe, effective, and scalable cell therapies to patients who need them.

Dr. Nika Shakiba, University of British Columbia, British Columbia

Cycle 5, Round 1: Impact Awardee Ensuring Safe, Scalable Stem Cell Manufacturing for Regenerative Medicine

Human pluripotent stem cells (hPSCs) have revolutionized the potential for regenerative medicine. With their unique ability to replicate and transform into any cell type in the body, hPSCs are the foundation of promising therapies now being tested in clinical trials—including treatments for diabetes that use lab-grown beta cells. As demand for hPSC-based therapies grows, Canada’s biotechnology sector is poised to lead the way in cell manufacturing at scale.

But a major roadblock stands in the way: as hPSCs multiply in large-scale bioreactors, they can acquire harmful genetic mutations. These cancer-like “variants” rapidly outcompete healthy cells, compromising the safety and integrity of the entire batch.

Dr. Nika Shakiba is addressing this challenge using a sophisticated bioengineering approach. Her team is leveraging cutting-edge genetic tracking tools to monitor hPSC populations in real time, while also developing computational models that predict the risk of variant overtake. By understanding how culture conditions influence variant growth, this work aims to optimize bioreactor design and establish reliable protocols for safe, large-scale hPSC production.

If successful, this research will unlock the full potential of regenerative medicine in Canada and beyond—ensuring cell therapies are not only innovative, but also safe, scalable, and ready for clinical use.

“Our goal is to de-risk stem cell manufacturing by predicting and preventing dangerous variants. This is about ensuring every cell therapy that is produced is as safe as it is powerful—turning scientific promise into clinical reality.”

Dr. Nika Shakiba, University of British Columbia, British Columbia

Cycle 5, Round 1: Early Career Researcher Jump Start Award Engineering Safer Stem Cells with Precision and AI

Human pluripotent stem cells (hPSCs) are extraordinary: they can make unlimited copies of themselves and transform into any cell type in the body. That’s why they’re the foundation of many regenerative therapies now entering clinical trials—including stem cell-derived beta cells for people with diabetes. But while these cells hold immense promise, growing them in large numbers is not without risk.

As hPSCs multiply, some pick up dangerous genetic changes. These “rogue” cells behave more like cancer than cure: they grow faster than their healthy counterparts and can take over an entire cell batch. Once that happens, the product becomes unusable for therapy—and millions of dollars in manufacturing costs may be lost.

Dr. Nika Shakiba is working to stop these variant cells in their tracks. Using a suite of powerful genetic and engineering tools, her team is developing a high-resolution system to track individual hPSCs, identify unwanted variants early, and understand how they gain an edge. By applying machine learning to analyze these data, her lab aims to uncover the signals that predict variant takeover before it occurs.

This work will support the safe, large-scale production of stem cells needed for regenerative therapies—helping Canada’s biotech sector scale up cell manufacturing and deliver high-quality treatments to patients.

“We’re building tools to detect dangerous cells before they compromise a therapy. It’s about protecting the promise of regenerative medicine—so it’s not just effective, but safe and scalable too.”

Dr. Marya Ahmed, University of Alberta, Alberta

Cycle 5, Round 1: Impact Award (SCN-Breakthrough T1D Joint-Funding Award) A Safer Way to Freeze and Store Cells for Future Regenerative Medicine Therapies

Cell-based therapies have the potential to transform treatment for many serious conditions, including type 1 diabetes. Today, some patients can receive transplants of insulin-producing islet cells, reducing or even eliminating their need for daily insulin injections. However, these transplanted cells don’t always survive long term, meaning patients may require multiple transplants to achieve or maintain insulin independence—or may eventually need to return to insulin therapy.

To make these therapies more widely available and effective, scientists need to solve a major challenge: safely storing the cells until they’re needed. Currently, freezing is the only way to preserve these sensitive cells. To survive the process, cells must be treated with chemical agents—but these often damage the cells or cause allergic reactions in patients.

Dr. Marya Ahmed’s team is developing new, non-toxic gels made from natural materials that can protect cells during freezing and thawing. These gels will first be tested with pancreatic cell clusters and later evaluated for commercial-scale production. This work could pave the way for safer, more effective cell-based treatments and create valuable intellectual property for Canada’s regenerative medicine sector.

“If we can store cells safely and effectively, we remove one of the biggest barriers to delivering regenerative therapies to patients when they need them.”

Dr. Peter Zandstra, University of British Columbia, British Columbia

Cycle 5, Round 1: Impact Award Using Artificial Intelligence to Fast-Track Stem Cell Therapies

Stem cells have the potential to transform treatment for many diseases, but turning them into specific, therapeutic cell types is a slow and expensive process. Today’s methods rely heavily on trial and error, specialized expertise, and complex lab work—barriers that limit progress in regenerative medicine.

Dr. Peter Zandstra’s project, IQCELL 2.0, aims to change that. This next-generation platform uses artificial intelligence and systems biology to decode how cells decide their fate. By combining experimental data with advanced machine learning tools, IQCELL 2.0 can predict and design the best protocols for turning stem cells into specific types—faster, cheaper, and more accurately than current methods.

Initially, the platform will be tested and refined using human T-cell data, then expanded to model the creation of other cell types like B-cells and liver cells. Collaborations with leading research and industry partners, including Apiary Therapeutics, Aspect Biosystems, and CCRM, will ensure real-world impact in areas like immunotherapy and regenerative medicine. Ultimately, IQCELL 2.0 will offer a powerful, scalable tool to speed up the development of new cell-based treatments.

“By combining AI with biology, IQCELL 2.0 will make it faster and easier to turn stem cells into the therapies patients need.”