Webinar: PAT and Model-Based Approach to Accelerate Biopharma Process Development
In the Face of the Pandemic: Learnings from Process Development during COVID
プログラム概要
- Efficient biopharma process development by data-rich experimentation
- Importance of solubility
- How in-silico tools can help to optimize process time and shorten the development phase
With the commercialization of lab automation and in-silico tools in the last decade, process development has been undergoing a significant transformation. When the COVID pandemic hit the world in 2020, the pharmaceutical industry faced an unprecedented high-pressure situation due to a shortage of key components for the COVID vaccines approved under Emergency Use Authorization (EUA) by the FDA.
These circumstances forced a re-evaluation of the process development strategy, driving the utilization of these novel tools to shorten timelines for commercial readiness. This is the success story of a PEG-lipid project at Merck KGaA, Darmstadt, Germany (operates as MilliporeSigma in the US and Canada) for COVID vaccines, fully developed and manufactured for commercial use within 9 months. This presentation highlights learnings and how these have shaped our approach to process development to this day.
Target Audience
Process development chemists, Scientists, Pharmaceutical industry
About the Presenter
Christian Rüeger
MilliporeSigma
Chris holds a BSc. in organic Chemistry from ZHAW and has been with Merck KGaA Life Sciences (MilliporeSigma in the US/Canada) for more than 9 years. In his current role as Senior Scientist, he works on the process development of activated PEG’s and PEG-lipids. As a generally tech-savvy person, he has a strong focus on lab automation and digitalization, being involved not only with the implementation of various lab automation solutions and PAT, but also the application of Dynochem and other software solutions to raise the bar of internal scale-up activities.
