What would you say are the key components to successful implementation of a single use system for manufacturing biologics in CHO cells? Are there important tips you could share?

Answer

One of the key components for single-use system manufacturing is the system’s ability to control the critical process parameters such as dissolved oxygen (D.O.), pH, temperature and agitation within your desired target range. Then, what are the appropriate or optimal control strategies that will achieve these critical process parameters. Dissolved oxygen for example: select a gas sparge element with a porosity that will provide an adequate kLa, without generating an excess amount of foam or negative levels of interfacial shear. This can be achieved through an appropriate sparge pore size, along with appropriate agitation rate (rpm). Additionally, the XDR controller, with the capability for gas cascading (i.e. air/oxygen blending), look-up tables and PID tuning can benefit this process greatly.