Nathalie Rigal | Head of USP Development
ProBioGen AG
Nathalie joined ProBioGen in 2018 and currently serves as Head of Upstream Process Development, leading the development of mammalian cell culture processes for therapeutic proteins and antibodies. With more than 18 years of experience in early-stage biologics process development, she combines extensive expertise in platform fed-batch, process intensification, and perfusion strategies with hands-on experience across a wide range of cultivation systems. Her current focus is on developing scalable, fit-for-purpose upstream manufacturing strategies that support efficient and phase-appropriate biologics development.
Appearances:
Festival of Biologics Day 1 @ 14:30
Navigating Speed, Complexity, and Scalability in Biomanufacturing Selecting Phase-Appropriate Upstream Strategies from Rapid Platform to Intensified Processes
The pressure to accelerate biologics to the clinic while accommodating an increasingly diverse range of molecule formats is reshaping biomanufacturing strategies. Using ProBioGen's CMC Navigator™ as an example of a structured manufacturing roadmap, this presentation explores how phase-appropriate CMC strategies and a fit-for-purpose manufacturing toolbox support informed manufacturing decisions aligned with evolving program priorities.
While platform fed-batch remains the preferred strategy for rapid clinical development, intensified fed-batch and perfusion offer opportunities to improve manufacturing efficiency where appropriate. Selecting the optimal strategy requires balancing development timelines, process complexity, scalability, and molecule-specific requirements rather than adopting a one-size-fits-all approach.
Drawing on a CDMO perspective, the presentation will feature case studies illustrating how different program priorities translate into different upstream process strategies, highlighting the trade-offs associated with scalability, operational complexity, and harvest design. In addition, examples of perfused seed trains and harvest strategies for intensified processes will highlight often-overlooked aspects of upstream process design, demonstrating that critical manufacturing decisions extend from seed train through harvest — not just the production bioreactor.
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