Optimizing Single-Cell Cloning Workflows for iPSC Manufacturing

From Robust Clone Outgrowth to GMP-Ready Cell Banks

Ensuring the clinical reliability of iPSC-derived products begins with genetically stable and well-characterized starting materials.

This webinar presents a multilayer strategy designed to safeguard the genomic integrity of iPSCs and examines a Master Cell Bank manufacturing process based on single-cell cloning. By integrating the VIPS™ platform for image-verified single-cell cloning and seeding together with CellMetric for automated clonal outgrowth imaging, the workflow supports traceable, high-confidence clone selection, an essential foundation for GMP-ready Master Cell Banks and downstream clinical manufacturing.

This approach enables the identification and expansion of genetically intact clones, strengthening the overall safety profile, ensuring consistent batch manufacturing and supporting the clinical robustness of iPSC-based therapies.

The featured panelists will discuss a workflow-centric approach to optimizing single-cell cloning for iPSC programs, spanning early clone establishment, culture condition selection and the transition toward GMP-ready Master and Working Cell Banks. Drawing on real-world development experience, the session will explore how media and matrix choices influence clonal performance, how cellular stress contributes to clonal drift and genetic instability and how upstream workflow design can mitigate these risks without relying on project-specific datasets.

The discussion will also highlight where single-cell recloning (“clonal reset”) and staged genetic integrity monitoring can be integrated into broader upstream strategies to support consistent, scalable and regulatory ready iPSC manufacturing. Attendees will gain practical insight into building robust single-cell cloning workflows, supported by image-verified technologies, that balance scientific rigor with real-world development constraints.

Register for this webinar to learn how iPSC manufacturing workflows can support genetically stable clones, GMP-ready cell banks and consistent clinical manufacturing.

Speakers

Noud Drummen, Field Application Scientist, Nova Biomedical

Noud Drummen partners with Cell Line Development teams across Europe, the Middle East and Africa to optimize workflows, streamline processes and drive innovation in laboratory operations, with a strong focus on the Solentim solutions. Noud combines a strong scientific foundation with deep knowledge of the Life Sciences market to help laboratories enhance efficiency and accuracy in single-cell seeding, culture monitoring and confident clone selection.

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Silvia Rosati, Research Scientist, Process Development Lab, Evotec (Modena)

Silvia Rosati is a Research Scientist in the Gene & Stem Cell Therapy group at Evotec in Modena, Italy. Within the Process Development Laboratory, she supports the advancement of ATMP programs through the development, optimization and standardization of iPSC-based workflows. Her work spans iPSC culture and differentiation, seed bank generation, gene editing and pre-GMP process development, enabling the transition toward GMP manufacturing.

Silvia also contributes to the design and implementation of GMP compliant procedures, ensuring that processes are robust, scalable and aligned with regulatory expectations. Through her work, she supports Evotec’s mission to deliver high-quality, next generation cell and gene therapy solutions.

Evotec SE is a global biotechnology company active in drug discovery and early-stage development. It collaborates with pharmaceutical companies, biotech firms and foundations to accelerate the development of innovative therapies. The company brings together deep knowledge of disease biology expertise, advanced technology platforms and highly industrialized R&D processes. Its portfolio includes a dedicated cell therapy business unit that plays a central role in advancing next generation therapeutic solutions, with a particular focus on developing iPSC-based therapies.

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