Single-use bioreactors come in all shapes and sizes that fit the variety of manufacturing conditions required for different biopharmaceutical production processes. WAVE Bioreactor technology, which was first introduced in 1996, has a unique rocking motion that provides for efficient mixing without the need for the use of internal stirrers. The industry has changed a lot in the last 17 years, though, and single-use bioreactor technology has evolved with it. To meet these changing needs of the biopharmaceutical industry, GE Healthcare Life Sciences has updated the WAVE Bioreactor system.
“We realize that the biopharmaceutical industry today constantly needs to develop to meet new regulatory requirements. It also now relies on many different types of cell-culture processes and is looking to leverage advanced process analytical technology while also increasing product yield and reducing turnover time. To meet these changing needs, we have developed a new WAVE Bioreactor system that builds on the functionality of the original bioreactor but is more advanced and yet easier to use,” says Cecilia Annerén, product manager with GE Healthcare Life Sciences. “Most importantly, she adds, “we have incorporated accurate and intelligent controls for numerous process parameters, many more automated functions, and a user-friendly interface that includes several data analysis and reporting options.”
More than just rocking
The ReadyToProcess WAVE 25 single-use bioreactor system consists of a rocker, a gas mixer, and a pump, all operated by software installed on a client computer. The rocker is used together with one of three trays that support disposable bioreactor cultivation chambers with working volumes up to 25 L. As with the original WAVE Bioreactor system, the rocker provides mixing through rocking and temperature and weight measurement through integrated sensors and load cells, respectively. The gas mixer delivers gas of a defined composition to the culture and is used, together with optical sensors in the bioreactor, for online control of culture pH and dissolved oxygen (DO).
In addition, the system has a new tilt position to facilitate sampling and harvest, and its rounded corners make for easier cleaning. “While the new features seem simple, they can have a big impact on the operators using the bioreactor. For example, the tilt position eliminates the need for heavy lifting when harvesting the bag, and the wide top-opening of the lid enables complicated manipulations of the bag without removing the lid,” Annerén notes. Furthermore, it is now possible to adjust the speed, angle, and motion of rocking. The latter parameter is new for the upgraded system and determines the acceleration profile, which at low settings creates a gentler wave motion that is suitable for cells on microcarriers and at higher settings creates the more aggressive waves that are required for robust cells with a higher oxygen uptake rate, according to Annerén.
Easy to use
In addition to the new design of the tray, the software that comes with the system, which was originally developed for use with GE Healthcare Life Science’s chromatography equipment, has been adapted specifically for operation of the updated rocking bioreactor and incorporates many features that are designed for user friendliness. “It was very important to us that, even though we have incorporated very advanced functionality into the new bioreactor, it continues to be extremely easy to operate, so that anyone can rapidly learn how to use it without the need for extensive training,” Annerén comments.
Areas of interest
While the first-generation WAVE Bioreactor has commonly been used in seed-train applications and small-scale production, there is, according to Annerén, growing interest from the process development community in the newer bioreactor. “Because it is so easy to adjust a wide variety of process parameters and monitor the changes in the culture conditions in real time, it is possible to very rapidly gather a large amount of data and evaluate the performance of a given biopharmaceutical process under numerous different conditions. As a result, process development times can be reduced, which is a major goal for all pharmaceutical manufacturers,” she observes.