ATF系统应用笔记高细胞密度种子库建立.pdfVIP

Applications Contact: John Bonham-Carter Tel +1 973 952 0002 jbonhamcarter@ Cell Banking Application Cell Banking Introduction The cell bank is a critical element of the manufacturing process. Procedures for creating and subsequent use of cell bank repositories are well established and have not changed significantly in years. These procedures often involve significant manual handling with an associated potential for contamination and variation. Furthermore, the time required from cell bank to inoculation of the first bioreactor is significant. It is a period which exposes the inoculum to various potential hazards. Through the novel use of the ATF™ System, it is possible to achieve a more robust cell bank with significant manufacturing advantages. Cells are rapidly grown to high cell concentrations, then prepared for freezing within the same culture vessel without removal. Cells are dispensed into single-use bags pre-attached to the culture vessel, speeding the creation of a more homogenous cell bank. The need for centrifugation and dilution/concentration is eliminated. This high density cell bank stores cells at sufficiently high cell numbers, eliminating the need for inoculum scale up and allowing the direct inoculation of a bioreactor. ATF-cellbanking Overview High density cell banking is not new – it is just difficult to achieve and validate. However ATF-cellbanking solves most if not all the problems encountered in this operation. It has the following advantages over other processes and equipment: • All steps are performed within the sterile reactor environment, including the final step of filling • Single use large volume bags are used for the ba