Improve Cell Line Stability From Cloning to GMP Manufacturing
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About this webinar
Maintaining cell line stability becomes increasingly important as programs move from early clone development toward scale-up, cell banking and GMP manufacturing. Variability introduced during cloning, culture and expansion can affect genetic integrity, reproducibility and confidence in the cells being carried forward. Using iPSC development as a key application, this webinar will explore how early workflow decisions can help identify and reduce these risks before they impact downstream manufacturing.
The featured panelists will explore how decisions made during clone establishment and early cell development can influence long-term cellular stability. The discussion will examine how culture conditions, media and matrix selection and cellular stress can affect clonal outgrowth and contribute to genetic drift, as well as how stronger clone-selection and monitoring strategies can help reduce these risks.
Using iPSC development as a key application, the speakers will demonstrate how single-cell cloning, image-verified clone selection and automated clonal outgrowth monitoring can provide greater confidence and traceability during cell development. They will also explore when recloning may be appropriate, how genetic integrity can be monitored at key stages and how these approaches can support the creation of robust, well-characterized cell banks.
The session will connect early cell-development decisions with broader goals including reproducibility, scalability, genetic integrity, manufacturing readiness and the development of well-characterized GMP-ready cell banks, giving practical considerations for building more reliable workflows.
Attendees will gain insight into how to recognize sources of clonal variability, strengthen clone-selection strategies, maintain confidence in genetic stability and reduce the risk of carrying early development problems into later stages.
Register for this webinar to learn how cell line stability can be strengthened through clone selection, genetic integrity monitoring and cell-development strategies that support scalable 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.