From scientific complexity to market execution.

Four ISSCR 2026 keynotes point to one conclusion: gene delivery is the real bottleneck in cell and gene therapy. What it means for CMC, CDMOs, and capital.

Figure 1. Evolution from autologous to off-the-shelf cell therapy. Comparison of autologous and allogeneic cell therapy manufacturing workflows. Unlike patient-specific manufacturing, iPSC-derived allogeneic therapies leverage Master Cell Banks (MCBs), standardized manufacturing processes, and large-scale production to enable scalable, off-the-shelf regenerative medicine. Executive Summary Key Takeaways Induced pluripotent stem cells (iPSCs) have evolved from a stem cell tech

Introduction: For the First Time, Treatment Is About More Than Controlling Blood Sugar For more than a century, the treatment of Type 1 Diabetes (T1D) has been relatively straightforward. If the body cannot produce insulin, we replace insulin. This approach has saved millions of lives since the discovery of insulin in 1921. However, if we look deeper, one important fact becomes apparent: We have never truly addressed the underlying disease. The problem is not simply a lack of

Introduction: The Next Step of CAR-T Is Not “Better” — It’s “Simpler” Over the past decade, CAR-T therapy has proven that we can treat cancer with engineered immune cells. But the real bottleneck is never efficiency, but rather: Too high cost The manufacturing process is too slow Patients can't wait The essence of traditional CAR-T is actually "personalized cell manufacturing". Now, a more fundamental question has arisen: What if CAR-T didn't need to be manufactured at all? T