
In the first part of a two-part interview, Paz Vellanki of Precision for Medicine explains what sponsors should bring to early FDA meetings and how manufacturing and assay readiness can delay rare disease trials.
Inline dissolved CO2 measurement & monitoring during cell culture and fermentation scale up offers significant benefits for process control, impacting productivity and quality attributes. Real-time dCO2 measurement complements routine dissolved CO2 measurements with a BGA during pre-clinical and commercial operations. This podcast explains why dCO2 should be measured as a critical process parameter, what actions can be taken based on dCO2 measurements, and how to implement real-time dCO2 measurement.






