A Robust Cell Manufacturing Bioprocess For Clinical Usage
Bioprocessing technologies used in scaling manufacturing production typically uses scale-up and scale-out approaches through microcarrier-based stirred tank bioreactors, wave bags or cell stackers and multi-layered flasks. However, during the research and development process of cell and gene therapies, there is a significant technical gap between basic research methods and these manufacturing process development, which causes problems such as increase in time and cost of the development process. Cell and Gene Therapy manufacturing is an emerging area in the biopharmaceutical industry that must overcome high barriers of resource, capacity, and cost constraints. Therefore, it is extremely important to consistently consider and design a culture process from R&D to commercialization as a closed system with a certain size of scale-up and automation.
This technology introduces a robust and economically viable culture process in a closed culture system which comprises of an automated cell culture medium change device that can be installed in commercial CO2 incubators, where the device is coupled with a patented microwell bag and V-shaped adhesion cell culture bag, capable of both spheroid culture (3D) and adhesion culture (2D). This novel technology has established a culture method that meets the requirements of clinical use by improving sterility, reproducibility, and operability, and produces a large number of uniform-sized clusters.
The technology owner is seeking partnerships and collaborations with institutions, hospitals, biotechnology and biopharmaceutical firms.