Optimizing Single-Cell Cloning Workflows for iPSC Manufacturing
About this webinar
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.
Who should attend
- Cell Therapy Scientists and Developers working on iPSC derived clinical products
- Upstream Process Development and MSAT Scientists (CGT and iPSC)
- CDMO Platform teams supporting iPSC-based therapeutics
- Translational Research and Cell Banking teams preparing for GMP transfer
- Scientists responsible for single cell cloning, clone selection and early manufacturing decisions
- Anyone involved in designing robust, scalable and compliant iPSC workflows for therapeutic applications
What you will learn
- Why single-cell cloning variability is a major upstream risk factor in iPSC programs
- How media, matrix and handling conditions influence early clonal outgrowth and stability
- Where cellular stress contributes to clonal drift and genetic integrity risk
- When single-cell recloning can be used strategically to mitigate the effects of genomic instability
- Why genetically stable starting materials are essential for clinical grade iPSC manufacturing
- How to design upstream workflows that support GMP-ready iPSC banking that ensure high-quality starting materials
Featured Speakers
Noud Drummen
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.
Silvia Rosati
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 is a global life science company specializing pioneering the future of drug discovery and development. Through strategic partnerships with pharmaceutical companies, biotechnology firms, academic institutions, and healthcare organizations, Evotec accelerates the development of innovative therapeutics. The company combines deep expertise in disease biology with advanced technology platforms, AI-enabled capabilities, and highly industrialized R&D processes to support the efficient translation of scientific discoveries into potential treatments.
In cell therapy, Evotec offers one of the industry’s most comprehensive end-to-end platforms for advancing iPSC-based projects from inception to clinic. This includes in-house GMP manufacturing and GMP gene-editing capabilities. We focus on indications requiring long-term cell engraftment, such as regenerative therapies (beta cells, cardiomyocytes, photoreceptors) and immune-modulation therapies (macrophages).
Additionally, Evotec provides integrated drug development solutions, covering safety assessment, CMC, process and analytical development, regulatory strategy, and clinical services for both autologous and allogeneic cell therapy candidates.
Partner for this event
Nova Biomedical
Advanced Instruments and Nova Biomedical now operate under the same brand, combining decades of expertise in analytical instrumentation, R&D, and global customer support. Nova Biomedical provides scientific and analytical solutions for bioprocessing, spanning cell culture monitoring, cell line development, liquid handling quality assurance, osmolality testing, and process optimization to help biopharmaceutical organizations increase efficiency and advance scientific discovery with confidence.