Sartorius Cell & Gene Therapy Workshop

[2:10 – 2:40]
‍
Mesenchymal Stem/Stromal Cells (MSCs) have significant therapeutic potential but require large-scale manufacturing for clinical applications. Traditional 2D static culture methods are unsustainable at scale and require manual operations. Successful transition from 2D to 3D microcarrier-based Stirred Tank Reactor (STR) expansion is an important step toward fulfilling the commercial demand of clinical grade MSCs. In this study, we show how a small scale a static culture was transitioned to a suspension format at 2L and then subsequently scaled up to 30L. Join this presentation to learn:

• Transition from 2D static culture to 3D suspension-based culture using a xeno-free media
• Successful scale-up of the expansion process to 30L scale using an STR
• Maintain cell characteristics from small – large scales by analyzing surface markers, immunosuppression, and karyotype

Speakers

Gilad Landes Gilad, Head of Technical Sales and Product Management Advanced Therapies, Sartorius

Dr. Ranit Lobel, PhD/MBA, Manager Technology Consultant, Sartorius

[2:40 – 3:00]

This topic explores how Computational Fluid Dynamics (CFD) can be leveraged to optimize mixing performance across different scales, from small-volume R&D batches to large-scale commercial production in biopharma manufacturing. Additionally, we will examine how Sartorius Linkit AX and MyCap® technology enhance closed-system automation, sterility assurance, and process control for seamless bioprocessing.

‍Speakers

Laura Peng, Product Specialist FMT Bag Technologies, Sartorius

Thomas Yu, Field Application Specialist FMT, Sartorius‍

[3:00 – 3:30]

‍Raw Extracellular Vesicles (EVs) coming from cell culture supernatant are heterogeneous in nature, including apoptotic bodies, microvesicles, exosomes, etc. Current research is providing further evidence that within these EV populations exist different subpopulations with variable targeting potential, payload, and ultimately therapeutic function. This therapeutic potential yet noted heterogeneity mandates reliable solutions that support robust process development, including the identification of EV critical quality attributes. This talk will explore the development of an optimized MSC-based process for EV production including cell culture, ionic exchange chromatography, and extensive analytics both up and downstream.

• Technologies that are foundational to generating analytics for EV characterization
• Optimization of a complete downstream process including an ionic exchange chromatography step
• Potential to characterize during upstream processing to maximize the functional titer of the desired EV population during scale-up

Speaker

Blaz Bakalar, Product  Manager, Sartorius‍

[3:30 – 3:40]

[3:40 – 3:55]

An automated, single-use solution designed to minimize contamination risks by reducing the need for manual handling. Ksep offers scalable counterflow continuous processing for aseptic cell concentration, wash, and harvest in cell therapy manufacturing, supporting high recoveries. By harmonizing a balance between centrifugal and fluid flow forces, it imparts very low shear on cells, ensuring high viability and yield. The automated cell wash feature enhances harvest quality in cell processing applications. The Ksep® system is adaptable from process development (0.1 L) to commercial manufacturing (200 L), providing seamless scalability.

‍Speaker

RZ Lin, Field  Application Specialist SEP, Sartorius

[3:55 – 4:10]

Extracellular vesicles (EVs) secreted by mesenchymal stem cells (MSCs) hold significant promise in cell therapy, particularly in drug delivery, diagnostics, and regenerative medicine. This talk will detail our innovative method for labeling and tracking EVs within host cells. Using the example of human MSC-derived EVs in a wound healing assay, we will showcase their efficacy in promoting tissue regeneration and repair.

• We will highlight the potential of MSC derived EV in cell therapy and their role in reducing inflammation and promoting wound healing.
• We will introduce Incucyte®ExofluorGreen EV Labeling Kit: A breakthrough tool for quantifying cellular uptake of exosomes, ensuring non-perturbing and reliable kinetic measurements.
• Research implication: The ability to track and analyze EV uptake opens new avenues for therapeutic applications and drug delivery systems.

Speaker

Vicky Lu, Field  Application Specialist, Sartorius‍

[4:10 – 4:25]

A robust analytical tool delivering virus counts in near real-time. This system is adaptable across various virus growth and purification processes, offering versatility across numerous applications. Pinpoint optimal harvesting periods, validate processing stages, and establish final formulations efficiently and confidently. Viruses are labeled using specific reagents, employing either a direct dye method or high-affinity monoclonal antibodies. Subsequently, samples undergo precise and intense laser illumination. This method facilitates swift, direct, and precise quantification of total virus particles within a sample.

Speaker

RZ Lin, Field  Application Specialist SEP, Sartorius

[4:25 – 4:55]

[4:55 – 5:30]