Improving Methodologies For iPSC Manufacturing & Differentiation

By Boris Gerber, Ph.D., Head of R&D Ipsc/CT, Catalent

Induced pluripotent stem cells (iPSCs) represent one of the most exciting breakthroughs in modern biotechnology, offering unprecedented opportunities for advancing regenerative medicine and cell-based therapies. These unique cells are created by reprogramming mature, specialized cells — such as those obtained from a simple biopsy — back into a pluripotent state. Remarkably, once reprogrammed, iPSCs regain the fundamental abilities of pluripotent stem cells: the capacity to self-renew indefinitely and to differentiate into virtually any cell type in the human body, including neurons, cardiomyocytes, pancreatic beta cells, and hepatocytes. This versatility positions iPSCs as a potential single, renewable source of therapeutic cells capable of replacing those lost to injury, degeneration, or disease.

For many years, embryonic stem cells (ESCs) were the only established model for pluripotency. While ESCs provided invaluable insights, their use raised ethical considerations and limited the scope of clinical application. The advent of iPSCs has changed this paradigm, offering a powerful, ethically acceptable alternative with the added advantage of drawing from diverse cell sources. As a result, iPSCs are increasingly viewed as a transformative platform for cell therapy and gene therapy development.

However, realizing the therapeutic promise of iPSCs is far from straightforward. These cells are a complex starting material, and translating them into clinically relevant therapies requires carefully orchestrated processes. Critical steps include precise gene editing, reliable differentiation into functional cell types, and scaling under stringent good manufacturing practice (GMP) standards. Each stage presents unique scientific and operational challenges, demanding both innovation and deep expertise.

In this executive summary, Boris Greber, Ph.D., Head of iPSC at Catalent, outlines how next-generation workflows are being developed to streamline iPSC manufacturing, enhance differentiation strategies, and enable pharmaceutical innovators to overcome the hurdles of scalability and consistency. With improved methodologies, iPSCs are moving closer to fulfilling their potential as the foundation for tomorrow’s transformative, patient-ready therapies.