Cell therapy: Early process development and optimization of the manufacturing process are critical to ensure viability of the product, quality, consistency and cost efficiency

摘要

In recent years cell therapies have evolved and matured, moving from academia to industry. Scale up of a process is the natural path of any product evolutionary development and maturation, this process not only allows higher manufacturing capacity to meet demands but rather to increases the yields and reduces cost of goods. Cells are living things that react to the environment and conditions in which they grow, therefore process changes should be done as early as possible. The traditional 2D culturing systems can not be truly up scaled, therefore there is a need to advance to bioreactors that will influence the product. Additionally, in order to make cell therapy viable, the cost of manufacturing is critical. Cost drivers such as media, serum, footprint, human resource and infrastructure must be optimized without changing the cells critical quality attributes. The paper analyze the main cost drivers on the cost of goods and is based on the experience of cell manufacturing in both traditional 2D and three dimensional (3D) bioreactor systems produced in Pluristem therapeutics GMP site. Furthermore, the paper discussed possible process development steps to insure cost efficiency emphasizing the need and benefit of early process development investment.