On-Demand Webinar
Sartorius’ process development services de-risk developers’ processes through extensive expertise, breakthrough technology, and robust process insights.
In this webinar, experts from Sartorius will present two case studies that highlight practical approaches to overcoming key challenges in emerging modalities and advancements toward GMP-compliant clinical manufacturing.
An iPSC expansion workflow will be used to demonstrate how process development toward stirred-tank bioreactor culture platforms and structured process innovation can be utilized to address current challenges in iPSC scalability. Particular focus on development of a scale-agnostic perfusion strategy for iPSC expansion in 3D aggregate culture will be described.
A second case will highlight a reproducible and scalable extracellular vesicle (EV) manufacturing approach with Stellar Notch, an EV therapeutic developer, improving insight into critical process parameters and quality attributes. Together, these examples address issues including complex cell culture, process variability and scale-up inefficiencies, illustrating how integrated, data-driven approaches can de-risk development.
What You Will Learn:
- Gain insights into the Sartorius process development approach, highlighting the focus on partnership and a collaborative, and evidence-driven development project framework.
- Understand how advanced modelling, experimental design, and analytics enable efficient, sustainable, and clinically ready processes are developed by the process development team.
- Learn about solutions that have been developed in response to critical process challenges recognized in the field (scale-up, media exchange strategies, critical quality assessment, and product characterization)
