2022 DIGITAL CMC SUMMIT / ON-DEMAND SESSION
Lifecycle Approaches for Robust Control Strategies
Take an in-depth look at how new data science methodologies are putting CMC processes on the path to predictive, adaptive, real-time capabilities.
Session highlights & insights
Where new data science methods have the potential to transformatively mature drug manufacturing processes.
Session Speakers
Meet the group transformation experts who share their insights and expertise in this on-demand session.
Dr. Christoph Herwig
Professor, Vienna University of Technology
Dr. Christoph Herwig
Christoph worked in biopharmaceutical process design and facility design prior to becoming a full-time professor of biochemical engineering at TU Wein. His research focuses on the development of data science methods for integrated and efficient bioprocess development along PAT and QbD principles for biopharmaceuticals. Christoph is now the Senior Advisor within Körber Pharma Austria, where he works closely with ISPE, Pharma 4.0, and digital transformation initiatives.
SUMMARY
Taking drug development to a new level of digital precision and predictability
Across the industry, CMC leaders continue to struggle with a range of critical goals – reducing time-to-market, streamlining tech transfers, minimizing batch failures, and more – that can only be achieved through transformative maturation of the drug manufacturing process. Data science experts like Dr. Christoph Herwig are leading the effort to help drug developers achieve that evolution.
He and his fellow researchers are focused on laying the groundwork for the shift from tightly controlled methods and reactively tested outputs to agile, flexible, continuously adaptive processes. The key to that transition: powerful, responsive, multi-dimensional control strategies that synthesize data from across the product lifecycle.
A leading innovator in data science applications for bioprocess designs, Dr. Herwig took 2022 Summit attendees on a deep-dive tour of how new digital modeling methods are shaping the next generation of drug manufacturing processes. In his keynote presentation, he shared in-depth scientific insights on:
- The development and deployment of digital twins, and how they can lay the foundation for continuous bioprocessing.
- How a holistic lifecycle approach to these models can help maximize consistency and quality across development stages and unit operations
- Why drug developers need to set new data management and architecture standards to fully unlock the industry-wide potential of these innovations
- A new model workflow for developing and implementing robust, end-to-end control strategies that can help CMC leaders achieve their performance goals
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