This presentation will show how Point-of-Care (POCare) solutions, powered by advanced technology and data, can overcome conventional CGT processing challenges. By enabling closed, automated, and reproducible workflows, therapies can be manufactured near hospitals and treatment centers within hours. The mission is to decentralise and standardise production, making innovative therapies more affordable, scalable, and accessible to patients worldwide—not only those in major or wealthier markets.

Broadening access by driving down the cost of manufacture using predictive and adaptive digital systems including the use of AI and AI agentic management systems.

Cell therapies are at a critical juncture with patient demand outstripping current manufacturing capacity. To address this challenge, the Cell and Gene Therapy Catapult has developed cell therapy manufacturing platforms that offer step-changes in throughput for autologous and allogeneic products by integrating end-to-end automation and digitising data flow and decision-making.

This presentation will show how digital shadows can be used to predict CAR T cell concentration based on online nutrient and metabolite data, including dissolved oxygen, glucose, and lactate concentrations. Such predictive modelling is designed to utilise the hard sensors that are already embedded in the bioreactor for process monitoring and control. As no additional process analytical technology is required, digital shadows provide a cost-effective soft sensor of cell concentration.

MUVON Therapeutics is a clinical stage Life Science Spin-off from the University of Zurich developing a novel therapy platform for the regeneration of skeletal muscle tissue based on autologous cells. We aim to provide safe, effective and affordable treatments to millions of patients suffering from seriously debilitating diseases by not only repairing damaged tissue but also increase the regenerative potential of weakened muscles. Our initial area of focus is the treatment of stress urinary incontinence in women, supporting them respectfully throughout their journey to a healthy life.

This presentation reviews recent and upcoming updates to the global regulatory framework governing advanced therapy medicinal products (ATMPs). It highlights evolving guidance on clinical development, manufacturing, and quality requirements, as well as new initiatives aimed at accelerating innovation and patient access. Emphasis is placed on understanding how these changes impact compliance and commercialisation strategies.

In vivo CAR T therapies redefine cell-therapy manufacturing by shifting engineering into the patient, but they introduce unique CMC and release testing challenges. Ensuring quality, consistency, and safety requires novel analytical frameworks for vector characterisation, potency assays, and biodistribution studies. This session will discuss evolving regulatory expectations, assay development strategies, and lessons learned in establishing robust CMC processes for first-generation in vivo CAR T products.

The IP-MS workflow is a powerful technique designed to enrich and analyse cell surface proteins, an area of growing importance in cancer immunotherapy given how these other proteins can affect T cell biology. By applying this workflow to surrogate CAR T cells, we not only confirmed the surface localisation of the CAR protein but also uncovered its associated proteome, offering valuable insights into molecular interactions that may influence therapeutic efficacy.

To avoid costly batch discards, it's essential to consider manufacturing challenges—such as bag integrity—already during the research phase. Leaks in single-use systems pose a serious contamination risk in ATMP and cell therapy production, threatening product quality and patient safety. This presentation offers a risk-informed approach to evaluating leaks, helping manufacturers reduce unnecessary product loss. Developed within BioPhorum, the insights reflect collaboration between industry experts, suppliers, and manufacturers.