🔬 The European Committee of ISCT and EBMT highlights the bottlenecks in manufacturing.
⬆️ The rapid growth of the sector necessitates skilled personnel and increased production demand.
🌍 Currently, there are only a few approved therapies, but the market is expected to expand.
🤖 Automation and robotization, combined with AI, can improve production efficiency and reduce costs and variability.
Introduction:
Robots and artificial intelligence (AI) could be the future of cell and gene therapy manufacturing, according to a recent joint paper by the European Committee of the International Society for Cell & Gene Therapy (ISCT) and the European Society for Blood and Marrow Transplantation (EBMT). The paper aims to identify the manufacturing challenges in the field and proposes that combining robots with AI-based control can help automate production and address these challenges.
- The rapid growth of the cell and gene therapy sector has resulted in manufacturing challenges, including the need for skilled production personnel to meet the increasing production demand. The approval of new advanced therapy medicinal products (ATMPs) by regulatory agencies will further contribute to these challenges.
- The cell and gene therapy market is currently small, with only a limited number of approved products in the US and EU. However, the market is expected to grow significantly in the coming years, leading to an increased demand for skilled production staff.
- To address these challenges, automation and robotization of processes are necessary. The optimization of allogeneic cell therapy products, which can be generated on a large scale, is particularly crucial. The use of bioreactors and other automated production tools can help reduce manufacturing times and costs.
- The elements needed for the automation of cell and gene therapy production already exist, and the combination of robots and AI can further enhance the efficiency and precision of manufacturing processes. AI can assist in the design of genetic constructs, process optimization, and personalized product selection for individual patients.
- The integration of robots and AI in cell and gene therapy manufacturing is still in its preliminary phase but holds great potential for large-scale and homogeneous production, reducing variability, costs, and time.
Conclusion:
The joint paper by ISCT and EBMT highlights the manufacturing challenges faced by the cell and gene therapy sector and proposes the use of robots and AI to automate production processes. By leveraging automation and AI-based control, developers can improve production efficiency, reduce costs and time, and meet the growing demand for cell and gene therapy products. Further research and development in this area will be crucial for the advancement of cell and gene therapy manufacturing.
