Abstract: Systems and methods for harvesting cells include a bioreactor with a structure for cell entrapment/adherence and growth, such as a fixed bed structure. A cell harvest mechanism is adapted to agitate the bioreactor, such as by vibrating or shaking the fixed bed, and to move a liquid level relative to the structure, such as by repeatedly flushing and filling the bioreactor. A cell detaching solution is provided to the bioreactor, such as an enzymatic cocktail for the detachment of cells without producing clumps or aggregates. The bioreactor may comprise a preculture vessel upstream of another bioreactor.

Abstract: An apparatus for culturing cells includes a bioreactor including a monolithic structured cell culture bed, which may be fabricated using additive manufacturing techniques, such as for example 3D printing. The bioreactor and monolithic structured cell culture bed may be formed as a unitary structure. The monolithic structured cell culture bed may include regions of varying porosity and/or surface treatments to achieve desired objectives. Related methods are also provided.

Abstract: A bioreactor includes a fixed bed for culturing cells and a sensor system for sensing a density of the cells in the fixed bed. The sensor may be selected from the group comprising: (a) a sensor for measuring impedance across at least a portion of the fixed bed; (b) a flowmeter for detecting a rate of flow of liquid associated with the fixed bed; (c) a sensor for measuring a pressure differential in a flow of liquid through the fixed bed; (d) a monitor, such as a light sensor or microscope, for detecting light from a light source for projecting light on or in the fixed bed, wherein the detected or measured characteristic is indicative of cell density in the fixed bed; (e) a chemical sensor within the fixed bed for detecting a chemical indicative of cell density in the fixed bed. Related sensor arrangements, systems, and methods are also disclosed.

Abstract: A cell culturing container including a fixed bed is provided for forming a bioreactor (100). In one version, a container in the form of a tubular body is formed by first and second interlocking portions (115a, 115b). The container forms a compartment for receiving the fixed bed (122) for culturing cells, which container may be removably inserted into an inner compartment of the bioreactor so as form an outer chamber for circulating fluid to or from the fixed bed. The container may also include a removable base (130) for receiving an agitator (118) for agitating and thus circulating the fluid. Related methods are also disclosed.

Abstract: Disclosed herein are systems, methods and devices for the continuous production and processing of compounds, including biopharmaceutical compounds. The system and devices are operated in an automated manner and capable of operation under Good Manufacturing Practice (GMP)-compliant conditions.