Bridging The Connectivity Gap Between Traditional Sensors And Single-Use Systems By Julie Stiller, Application Development Manager, David Koechlein, Application Development Manager, and Derek Pendlebury, Global Sales Director, Colder Products Company Critical process parameters (CPPs) are the key variables in the pharmaceutical manufacturing process that are most likely to affect the quality attributes of a biological product. CPPs must be monitored and controlled throughout the various stages of production. For example, in the production of recombinant proteins, the cell culture expansion and production steps require continuous real-time monitoring and control. Any deviations in CPPs from the historical data gathered during the process development steps could negatively impact cell growth and, therefore, product yield. They can also potentially affect the drug’s overall safety and efficacy. The most common CPPs measured are pH, dissolved oxygen, capacitance, and biomass. Another example is in media or buffer preparation, where conductivity is used to measure and maintain the ionic strength of the solutions.