Investigating Process & Product Related Impurity Testing of Cellular Therapeutics
Time: 1:00 pm - 3:00 pm
day: Pre-Conference Workshop Day – Workshop C
In the course of manufacturing, chemicals may be added upstream as part of the bioprocess to improve product expression and recovery; of course, these are removed but some residuals remain. Equally, there may be product related impurities for example, host cell protein, host cell DNA, N-terminal truncations etc. Therefore, assays must be employed to ensure that any impurities present are below pre-determined levels.
- Understand best practices to reduce or eliminate impurities to acceptable levels for risk mitigation
- Learn to identify and quantify impurities for process consistency and product purity
- Outline tools used to measure and characterize impurities, including mass spectrometry – how can we develop more rapid testing methods?