Cell therapy isn’t as new as many believe. The concept of using cells as a therapeutic tool has been around for centuries. Blood transfusions, for instance, have been saving lives for centuries, and xenotransplantation, like using pig heart valves in humans, has been performed since the 1960s. These are early forms of ‘cell-based’ therapies that paved the way for the sophisticated treatments we see today.
What truly sets modern cell therapies apart is their precision and scope. Take CAR-T cell therapy, for example. CAR-T therapy has transformed cancer treatment by reprogramming a patient’s own immune cells to target and destroy cancer cells. As of 2020, over 1,400 cell therapies were either in research or on the market globally, with CAR-T cell therapies alone seeing a 50% increase in active clinical trials compared to the previous year. Notably, CAR-T treatments like Kymriah and Yescarta have achieved objective remission rates of 52% and 82%, respectively, for certain types of relapsed or refractory lymphomas.
Balancing Personalized Medicine and Scalable Manufacturing: The Dual Demands of Cell Therapy Production
More than just Car-T cells
And this is just the beginning. New advancements in cell therapy are poised to tackle even more complex diseases. For instance, T-regulatory (Treg) cells are being explored to treat autoimmune conditions by restoring the body’s immunological balance. Despite the challenges in ensuring their stability and specificity, Treg therapies hold immense potential to revolutionize how we treat diseases like multiple sclerosis and type 1 diabetes.
Moreover, therapies involving natural killer (NK) cells and tumor-infiltrating lymphocytes (TILs) are showing promise. TIL therapy, in particular, has led to complete tumor regression in about 20% of metastatic melanoma cases and significant tumor reduction in over 50% of patients. This therapy involves isolating and expanding T cells from a patient’s tumor and can result in a staggering ~100000-fold increase in TIL numbers before being reinfused into the patient, demonstrating the power of precision medicine.
The market for these therapies is booming as well. Valued at around $9.5 billion in 2021, the global cell therapy market is expected to surpass $23 billion by 2028, driven by advances in CAR-T therapies and new cell types entering clinical use. Wait till they see the awesome power of Dendritic cells and macrophages!
As our understanding of the immune system deepens, and our ability to manipulate cells improves, we may soon be able to reprogram the body’s own defenses to not just combat but potentially cure conditions once considered untreatable. The future of cell therapy is bright, not just for cancer but for a range of diseases affecting millions worldwide.
Where to find help as an innovator in this space?
It is all well and good to highlight the transformative potential of cell therapies and their achievements in the therapeutic space. However, a critical factor that often goes overlooked is the significant gap in manufacturing and regulatory support for new innovators, particularly in Canada.
For example, let’s say you are a new innovator in Canada developing a cell therapy targeting autoimmune diseases. First, you need to provide substantial preclinical evidence demonstrating the safety and efficacy of your therapy. This is followed by the preparation of Chemistry, Manufacturing, and Controls (CMC) packages to prove that your therapy can be produced under stringent conditions. This must contain your Quality and Regulatory strategies and cGMP compliant tactics. Next, you must secure access to specialized manufacturing facilities, as these are often overbooked (wait times could be 1-2 years long!!) and personalized medicine leaves little room for scheduling errors. Wait times for manufacturing slots can be very long, and this must be taken into consideration before launching your clinical trial plan. Furthermore, supply chain logistics must be thoroughly vetted and managed by qualified personnel to ensure an uninterrupted flow of necessary components.
Despite the presence of larger players like Eurofins and CCRM/ OmniaBio in Canada, there remains a shortage of Contract Research, Development, and Manufacturing Organizations (CRDMOs) equipped to support therapy development effectively. This is why organizations like Alberta Cell Therapy Manufacturing (ACTM) play a pivotal role. ACTM provides crucial support for innovators by offering specialized manufacturing capabilities and regulatory expertise, which are essential for advancing novel cell therapies from the lab to clinical use.
Addressing these bottlenecks is imperative if we want to harness the full potential of cell therapies and make them accessible to patients in need.
Ready to revolutionize healthcare with cell therapies?
Whether you’re an innovator, researcher, or industry enthusiast, it’s crucial to understand both the potential and the hurdles in this evolving field..
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