A single dose of life-saving mesenchymal stem cell (MSC) therapy requires billions of cells. To reach this clinical benchmark, traditional workflows that use two-dimensional (2D) cell culture methods require hundreds to thousands of individual culture vessels in an expansion seed train. Furthermore, the 2D process is comprised of several manual operations, including open handling steps, which increases the risk of contamination. Thus, scale-up strategies using microcarrier-based three-dimensional (3D) suspension processes are significantly more sustainable, efficient and cost-effective.

Recently, a Phase I trial for the use of MSCs to treat graft-versus-host-disease (GVHD) was completed by the Midwest Stem Cell Therapy Center (MSCTC) at the Kansas University Medical Center (KS, USA). To scale-up to meet the demands of phase II and phase III trials, MSCTC transitioned their established 2D culture process to a 3D suspension-based platform using the Sartorius MSC Pilot Solution. This webinar describes the rapid and successful process transfer and scale-up.


Rupal Soder, Ph.D.

GMP Facility Manager
Midwest Stem Cell Therapy Center at KU Medical Center

Rupal Soder is a GMP Facility Manager at KU Medical Center’s Midwest Stem Cell Therapy Center. She holds a PhD in Biomedical and Pharmaceutical Sciences from the University of South Carolina (SC, USA). The Center manages the clinical trial projects through process development, critical process parameter identification, validation, operations and quality support. Dr Soder currently manages the good manufacturing practice (GMP) manufacturing and quality activities for early phase clinical trials for MSCs and T-cell expansion platforms, cGMP cell therapy process development and scale-up and optimization of GMP manufacturing processes.

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