Hard Lessons Learned Throughout A Legacy Cell Culture Process - Seguridad Mania.com - España y América Latina

The management of processes spanning a decade or more is complicated for many reasons, not the least of which is due to raw material variability.  There are many factors making raw material/supply chain management difficult. The reduction in the time spent in development/clinical phases results in less number of raw material lots used and hence less understanding of the potential variability in the raw material and the effect that variability has on the process. That critical dependency does not get understood until the molecule is being manufactured routinely commercially. Additionally, cell culture and fermentation media are often based on undefined or poorly defined hydrolysates which are known to vary in key components. Adding further to the raw material complexity is the fact that frequently raw materials are sourced from a single facility/manufacturer, and simple innocuous changes in their manufacturing can have disastrous results to a process. Lastly, the end supplier often has a complex supply chain themselves, and the inputs to their process could have variability that affects the drug manufacturer’s process.  This webinar will example a few key raw material-related disruptions to normal manufacturing. Presented by Ron Bates, Director at Bristol-Myers Squibb