Generating clonal, edited cell lines with high-precision, audit-ready evidence of clonality without compromising downstream efficiency is a critical challenge in IND-enabling cell line development. This is especially relevant for epithelial cell lines, which are engineered for therapeutic protein-producing cell platforms in CGT but lack optimized single-cell seeding workflows. Manual handling limited early visibility, and fragmented documentation can lead to ambiguous records, repeated subcloning and delays in downstream characterization and tech transfer.
In this webinar, scientists from CCRM/OmniaBio will share their experience applying lessons from hPSC workflows to establish a robust, GMP -compliant epithelial cell line workflow. By combining gentle single-cell seeding with whole-well, time-stamped imaging from day 0 to colony maturity, the team generated clear evidence of clonality while reducing manual interventions and workflow variability. Media and seeding conditions were optimized to support single-cell survival and outgrowth. Efficient use of clonality data overcame limitations of high-throughput assays for edited clone identification, broadening its applications beyond clonality confirmation.
Attendees will learn how early confirmation of clonality accelerates epithelial cell line development, minimizes rework from ambiguous wells and enables standardized, audit-ready documentation for tech transfer. The session will highlight CCRM/OmniaBio’s successful implementation of this approach in a real-world CDMO setting, demonstrating how early clonal confidence derisks downstream development while enabling scalable, GMP-aligned workflows for primary cells.
Register for this webinar to learn how early confirmation of clonality can strengthen cell line development, reduce rework and support GMP-aligned workflows.
Speakers
Adam Causer, Global Product Manager, Solentim Portfolio, Nova Biomedical
Adam Causer is a Global Product Manager for the Solentim Portfolio at Nova Biomedical, which includes an ecosystem of instruments that digitalize and automate CLD workflows. Prior to starting this role, he worked in Application Sciences at both Scienion and Advanced Instruments, specializing in precision dispensing and single-cell isolation for diagnostic test development and CLD, respectively.
Adam’s early career included being a Postdoctoral Researcher that oversaw the day-to-day management of Cancer Research UK (CRUK), National Institute for Health Research (NIHR) and university-funded research projects. For these projects, he used a combination of basic science and physiological techniques to investigate the benefits of exercise on health, disease and pharmaceutical treatments. These techniques included cell culture, live cell imaging, flow cytometry, cell killing assays and multiplex protein quantification.
Sakthi Moorthy, Lead Scientist III, Centre for Commercialization of Regenerative Medicine
Sakthi Moorthy is a Lead Scientist III at CCRM, Toronto, and a Subject Matter Expert in gene editing and analytical development. She leads cross-functional teams focused on genome-engineered cell lines and advancing allogeneic cell therapies for clinical use. She has established scalable, IND-enabling workflows using multiple gene editing technologies, translating innovative approaches into GMP-aligned, industry-ready processes.
With over 12 years of experience in gene editing, Sakthi brings deep expertise in process development, analytical strategy and building robust, reproducible manufacturing platforms. She completed her postdoctoral training at the University of Toronto, specializing in gene editing and pluripotent stem cell differentiation toward lineage commitment.
Her work focuses on bridging early innovation with commercialization to support the development of safe, scalable and clinically viable cell therapies.
Who Should Attend?
This webinar will appeal to:
- Cell Line Development Scientists working with hPSC/epithelial cells or gene-edited workflows
- Process Development and CMC teams supporting GMP-compliant pipelines
- CDMO and CRO Scientists responsible for clonal documentation and tech transfer
- Bioprocess and Analytical Leaders focused on reducing CLD timelines and rework
- Quality and regulatory professionals involved in clonality assurance strategies
What You Will Learn
Attendees will gain insight into:
- Achieving early, unambiguous proof of clonality from day 0
- Strategies to reduce manual handling, subcloning and workflow variability
- How CCRM/OmniaBio standardized clonality documentation to support GMP-compliant workflow
- The impact of early clonal confidence on cell line development and throughput
- Practical considerations for integrating early clonality confirmation strategies into GMP-minded CLD workflows
Xtalks Partner
Nova Bio
Advanced Instruments and Nova Biomedical are now doing business under the same brand, bringing together decades of expertise in analytical instrumentation, R&D, and global customer support. The Solentim® ecosystem is now part of Nova Biomedical’s portfolio, providing best-in-class imaging and single-cell deposition technologies for cell line development workflows and assurance of clonality for regulatory bodies.
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