This technical note presents the benefits of using a single-use heat exchanger and its areas of application. Successful cell culture on a large scale requires close control of the culture environment in terms of temperature, pH, removal of waste products, and addition of fresh nutrients. To produce high yields of a desired protein, precise control over such parameters at every step in a process is required. Additionally, FDA regulations require that various steps be taken to control bioburden and maintain…
Author Archives: Niraj Chandarana
Exploring Options for Dual Sourcing of Single-Use Components
As the bioprocess industry progressively adopts single-use technologies for large-scale manufacturing (1, 2), biomanufacturers’ increased reliance on integrators for critical production equipment continues to raise concerns about supply chain security. The need to mitigate risks associated with the supply of single-use components (e.g., bioreactors, aseptic connectors, tubing, filters) has led to growing interest in the dual sourcing of those materials. To that end, integrators and end users alike are exploring the definition of functionally equivalent products, how functional equivalency can…
Reduce Cost, Increase Quality, and Shorten Cycle Time in Upstream Manufacturing with a Single-Use Heat Exchanger
Successful cell culture on a large scale requires close control of the culture environment in terms of temperature, pH, removal of waste products, and addition of fresh nutrients. To produce high yields of a desired protein, precise control over such parameters at every step in the process is required. Additionally, FDA regulations require various steps to be taken to control bioburden and maintain sterility. These controls and regulations in cell culture environments have led to an increasing move toward single-use…