HIGH YIELD METHOD AND APPARATUS FOR VOLUME REDUCTION AND WASHING OF THERAPEUTIC CELLS USING TANGENTIAL FLOW FILTRATION

摘要

The present invention provides processes for aseptically processing live mammalian cells in an aqueous medium to produce a cell suspension having a cell density of at least about 10 million cells/mL and cell viability of at least about 90%. These methods comprise a step of reducing the volume of the medium using a tangential flow filter (TFF) having a pore size of greater than 0.1 micron, during which step the trans-membrane pressure (TMP) is maintained at less than about 3 psi and the shear rate is maintained at less than about 4000 sec-1. The invention also provides a complete process for large scale manufacturing mammalian cells for use in a therapeutic composition, and scalable, fully disposable systems for carrying out the process, using readily available disposables and pumps.