Establishing a new production process is expensive and can take years to set up. At each step, from biosynthesis to formulation, materials must be validated to eliminate contamination risks. Disposable, single-use technologies eliminate cleaning validation steps, providing significant time and cost savings.
Advantages of Disposables
Setting up, validating, and testing a new process in a fixed plant may take between two to four years. With single-use technology, this time span can be reduced by two thirds. Single-use fluid management and bioreactor bags cut the time of cleaning- and sterilization-in-place from days to minutes. Single-use technologies also have a smaller footprint and reduce consumption of resources such as labor, high purity water, and cleaning agents.
Single-use technology makes production operations responsive and agile. When upstream titers increase, single-use modules can be used to add extra capacity and allow downstream operations to keep up. Changeover between products can be made quickly and with a reduced risk for cross-contamination.
This is particularly useful when there is a need for several product candidates or when smaller patient populations require personalized therapies. Finally, single-use technology increases preparedness for pandemics and bioterrorism that require fast and flexible responses in terms of scale-up and location.
ReadyToProcess is from Start to Finish
The ReadyToProcess platform brings seamless, scalable implementation to upstream and downstream operations in biopharmaceutical production. It is designed to simplify and accelerate process design and manufacturing, reduce time-consuming activities, and increase your manufacturing agility. With the ReadyToProcess platform, rapid response, flexibility, and product safety are possible from start to finish.
The ReadyToProcess range includes systems and accessories for cell culture and fermentation, separation and purification, fluid management, and connectivity.