The innovative system allows precise, automated, and intelligent control of numerous process parameters through a user-friendly graphical operator interface, which provides real-time control and many data analysis and reporting options. ReadyToProcess WAVE 25 is a versatile system suitable for research, process development, and biopharmaceutical manufacturing applications.
The complete system comprises a rocker, gas mixer, and pump, all operated by UNICORN™ control software. The system supports the use of disposable Cellbag™ bioreactor cultivation chambers with working volumes of up to 25 L. Set-up is quick as suitable parameters can be automatically determined for the run using a library of predefined controls tailored for different cultivation volumes. In addition, ReadyToProcess WAVE 25 automatically monitors culture conditions and rapidly responds to changes to optimize performance, providing accurate and stable control of the process.
ReadyToProcess WAVE 25 is a robust and reliable system suitable for biomanufacturing of products in a regulated environment. The UNICORN software supports use in a manner that complies with 21 CFR Part 11 and good automated manufacturing practice (GAMP) 5. The software allows remote control and the optional setting of alarm conditions for essential parameters including heating, gas flow, carbon dioxide, pH and dissolved oxygen, for reliable cell culture operations.
Novel features of the system include a tilt function to facilitate sampling and harvest, and adjustable rocking speed, angle, and motion to suit cultivation of many different cell types.