GE Healthcare Life Sciences Data file 28-9520-58 AC WAVE Bioreactor™ 2/10 and 20/50 systems WAVE Bioreactor 2/10 and 20/50 systems (Fig 1) are part of GE Healthcare Life Sciences’ ReadyToProcess platform of ready-to-use products. The system is a cell culture instrument for the production of recombinant proteins in mammalian and insect cell lines in batch, fed-batch, and perfusion culture. Culture medium and cells are loaded into the Cellbag™ bioreactor, which is a single-use, presterilized bag. The Cellbag bioreactor is placed on a rocking base. The rocking motion induces waves in the cell culture fluid within the Cellbag bioreactor to provide efficient mixing and gas transfer (Fig 2). The resulting environment within the Cellbag bioreactor can easily support 1 × 107 cells/mL. The Cellbag bioreactor requires no cleaning or sterilization, providing easy operation and protection against cross-contamination. As part of ReadyToProcess platform, WAVE Bioreactor brings flexibility and speed to upstream processing of biologicals. ReadyToProcess platform comprises WAVE Bioreactor systems, WAVE Mixer™, tubing sealers and fusers, hollow fiber and normal flow filters, prepacked chromatography columns, and ÄKTA™ ready chromatography system with a disposable flow path, as well as the assemblies and connections in between. The platform is scalable from the lab bench to manufacturing. WAVE Bioreactor 2/10 and 20/50 systems deliver: • Convenience: Presterilized, single-use Cellbag bioreactors protect against the risk of cross-contamination, require no cleaning, and involve minimal validation and they are supplied in a ready-to-use format • Reliability: Cellbag bioreactors, including all fittings and filters, are supplied sterile and ready for use. They are suitable for cGMP commercial production and a biosafety cabinet is not required for inoculation or sampling Fig 1. WAVE Bioreactor 20/50 system with WAVEPOD™ II Integrated Controller. • Flexibility: Multiple instrument configurations for suspension, microcarrier, batch, fed-batch, or perfusion culture • Versatility: The systems are capable of handling culture volumes from 100 mL to 25 L Principles of operation Cellbag bioreactor The Cellbag bioreactor is a presterilized inflatable plastic bag that forms a disposable cell cultivation chamber. The bioreactor is available in different sizes, in both standard and customized configurations. The Cellbag bioreactor is used together with the electrically driven rocking base. Rocking base The rocking base is electrically heated and it is designed to inflate and rock the bioreactor for rapid gas transfer and mixing. The wave action sweeps up cells and prevents settling in the bioreactor. The gentle wave action limits shear force effects on the cells. Inflated plastic bag forms a disposable cultivation chamber Wave Cell culture Fig 2. Principle of operation of the rocking base. Rocking motion

System specifications and selection To select the correct WAVE Bioreactor system for your application, first determine the Cellbag bioreactor size you need by estimating the culture volume you require and then select the appropriate instrumentation and options (Table 1). Table 1. Specifications for WAVE Bioreactor 2/10 and 20/50 systems Integral features Speed and angle control Temperature control Aeration Speed and angle control Temperature control Aeration CO2/air mix controller O2/air mix controller Dissolved oxygen Optical monitor Perfusion controller WAVEPOD II Integrated Controller with...

A special cabinet designed to contain WAVE Bioreactor 20/50 systems is available. The cabinet provides a space saving unit for up to three systems. Slideout shelves provide easy access to instrumentation and the cabinet is mounted on casters for portability. The cabinet fits through standard doorways and in addition, the cabinet has CO2/O2 manifold for gas distribution, removable stainless-steel door and sides. Digital speed and temperature controls Digital electronic PID controller (Fig 6) maintains precise control of temperature, speed, and angle. These industrystandard units do not require...

Heater Pad and surface RTD temperature sensor Analog output and alarms A Heater Pad (Fig 7) is included in the Cellbag Holder Kit, which is linked to a surface temperature sensor for accurate temperature control (Fig 8). Process parameters such as speed and temperature can be supplied as an analog output from the mini-din jack on the back of the unit. In addition, we provide a dry contact that can interface with your system to alert you when an alarm goes off. Cellbag bioreactors Fig 7. Heater Pad is located on the tray, under the Cellbag bioreactor. Cellbag bioreactors (Fig 10) are made of USP...

Ordering information Monoclonal antibodies The WAVE Bioreactor system has been used extensively for monoclonal antibody production. Culture can be started at low volume and then fresh media added whenever the cell count is sufficiently high. This enables inoculum scale up without transfers. Batches ranging from 100 mL to 580 L were run with cell densities over 10 × 106 cells/mL, resulting in productivity and product quality that is comparable to that of stirred tank bioreactors. DO concentrations are typically not limiting and remain above 50% saturation. Anchorage-dependent cells Agitation in...

Related products Code number Related products Other ReadyToProcess products Code number Bag sensor adaptor 2.5 m assembly Other ReadyToProcess products Sterile Tube Fuser-Dry 28-9996-02 Tube Holder Set for 15.5 mm (5/8 in) OD tubing 28-4116-81 tubinglclamped tube holder set for wet welding; Tube Holder Set for 19.1 mm (3/4 in) OD tubing 28-4116-82 Tube Holder Set for 11.2 mm (7/16 in) OD tubing 28-4116-83 Tube Holder Set for 11.2 mm (7/16 in) OD tubing (clamped tube holder set for wet welding; Tube Pinch Holder Set for 6.4 mm (1/4 in) OD tubing 29-0026-29 Tube Holder Set for 6.4 mm (1/4 in) OD...