Magnetic Bead Removal Using Microcarrier And Cell Separation System

The criticality of reproducible manufacturing in cell and gene therapies underlines the cGMP regulation requirement for quality by design in every step of the process. Complex manufacturing processes call for new manufacturing tools to drive closed-system processing, reduction in operator error, and standardization across therapy modalities. Product quality considerations are not new; even with recent technology advancements, numerous challenges surrounding industry standardization remain, heightening the hurdles on the path to commercialization. An extremely variable unit operation in cell therapy processing involves the complete removal of magnetic beads from target cells. The FDA holds strict requirements for magnetic bead removal prior to therapeutic use making consistent results paramount.

Through the Magnetic Bead Removal Using Microcarrier and Cell Separation System Study, Entegris' microcarrier and cell separation system was incorporated into an optimized bioreactor subculturing process to maximize viable cell recovery and obtain a high split ratio between bioreactors during scale-up. A logical extension of this technology is to apply a similar process to commercial-scale bioreactor systems. Here we explore a strategy for accomplishing this, by employing a chain of bioreactors of gradually increasing size to obtain large quantities of seed cells to inoculate into a final bioreactor culture.