From research to clinical production: scaling iPSC and extracellular vesicle processes with confidence
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 addresses 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.
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What will you 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 modeling, 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)
Who this may interest?
- Process development scientists
- Principal investigators
- Early-stage biotech and biopharma companies
- Stem cell developers
- EVs and exosome developers
Sarah Gilpin
Principal Scientist, Process Development
Sartorius
Sarah Gilpin leads the process development team for iPSC / MSC modalities. She joined Sartorius in 2024 with a background in stem cell and developmental biology, cell biomanufacturing, tissue engineering and regenerative medicine. She obtained her PhD at the University of Toronto (Canada), focused on stem cell biomarkers in organ transplantation, and completed post-doctoral training at Harvard Medical School (MA, USA) in tissue and organ engineering, before holding scientific positions at the Wyss Institute for Biologically Inspired Engineering (MA, USA), United Therapeutics Corporation (MD, USA), and Astellas Pharma (IL, USA), leading teams in microphysiological models, stem cell production, and translational stem cell therapies.
Mehdi (Aslan) Dehghani
Manager of Nanoparticle Technologies
Sartorius
Mehdi (Aslan) Dehghani has 11 years of experience in the field of EVs, leading projects at Sartorius that focus on fundamental studies around EV production, purification and characterization by evaluating and developing new technologies and solutions for upstream and downstream processing as well as characterization. Before joining Sartorius Stedim North America in 2019, Aslan completed his PhD degree from Rochester Institute of Technology (NY, USA) focusing on purification, characterization and therapeutic potential of EVs. He has published over 10 peer reviewed articles on EVs bioprocessing as well as an invited book chapter. Additionally, he has been an invited speaker to the world stem cell summit, the 1st and 2nd American exosome and RNA conferences, International Society of EVs, and Exosome Therapeutic Summit. He has been also honored with the “Young Investigator of the Year Award” at the international society of EVs in 2020.
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