From Research to GMP-Ready Cell Lines: Bridging the Development Gap (Broadcast 2)

Biotech, Cell and Gene Therapy, Drug Discovery & Development, Laboratory Technology, Life Science, Pharma, Pharma Manufacturing & Supply Chain,
  • Tuesday, October 14, 2025 | 8am PDT / 10am CDT / 11am EDT (N. America)
  • 60 min

Transitioning innovative cell-based therapies from research environments to GMP-compliant manufacturing presents recurring challenges—whether in academia or industry. Inconsistent documentation, manual workflows, and lack of early quality planning often delay or derail progress.

This session explores how expert consultancy and automation platforms can help bridge these gaps. The speakers will discuss real-world examples, including how one team navigated the complexities of regenerating a previously hand-picked cell line under GMP requirements.

Register for this webinar to learn how early adoption of scalable tools and good documentation practices can support faster, more reliable translation to the clinic.

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Speakers

Dr. Zoe Hewitt, Regenerative Cell Therapy Consulting (Regen CTC) Limited

Dr. Zoe Hewitt, Co-Founder and CEO, Regenerative Cell Therapy Consulting (Regen CTC) Limited

Zoe has a background in pluripotent stem cells, which started in 2001 when she obtained her PhD from the Roslin Institute/University of Edinburgh. After completing her studies, she worked with a team developing differentiation protocols for hepatocytes, before moving to the University of Sheffield in 2006, where she established and managed a clean room facility, which was responsible for deriving the UK’s first clinically available human embryonic stem cells (MasterShef lines 1 to 14). Within this facility, Zoe and her team were responsible for delivering the starting master cell banks (Shef1) for the London Project to Cure Blindness. This resulted in the first successful UK clinical trial of an hPSC-derived retinal pigment epithelium (RPE) cell replacement therapy.

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In 2015, Zoe moved away from active research, becoming a Project Manager for the UK Regenerative Medicine Platform (UKRMP), firstly for the Pluripotent Stem Cell Platform (PSCP), winning the UKRMP Special Merit Award in 2017, and then for the Pluripotent Stem Cell and Engineered Cell (PSEC) Hub. The goal of the UKRMP Hubs was to advance regenerative medicine therapies by delivering innovative approaches to the rate-limiting steps of hPSC-based cell replacement therapies to enable clinical delivery and commercial development.

Zoe co-founded Regenerative Cell Therapy Consulting Limited in May 2022, where she now uses her considerable expertise to assist innovative research in translating from laboratory research to commercial development and investment.

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Claire Richards, Cellected

Claire Richards, PhD, CEO, Cellected

Claire Richards completed her PhD from the Wellcome Trust Sanger Institute, Cambridge University, which is a part of the Cancer Genome Project. She subsequently joined Horizon Discovery (now Revvity) as Team Leader in Cell Line Engineering, using CRISPR and rAAV editing techniques, and was the Head of Biology at Solentim, where she developed expertise in automated single-cell cloning, imaging and developed their iPSC workflow.

Currently serving as the CEO at Cellected, Claire leads strategic initiatives to revolutionize bioprocessing methodologies tailored to iPSCs. Her visionary leadership and technical acumen have been instrumental in propelling Cellected to the forefront of the industry.

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Sivane Koskas, Advanced Instruments, LLC

Sivane Koskas, PhD, Global Product Marketing Manager, Solentim Portfolio, Advanced Instruments, LLC

Sivane Koskas serves as the Global Product Manager for the Cell Metric Portfolio at Advanced Instruments. With a foundational background in cancer genomics from her PhD studies, Sivane transitioned from academic research at the INSERM/CNRS Institute for Advanced Biosciences to a career focused on bridging scientific innovation with practical applications in the biotech industry. Her journey through roles in product marketing and management has been marked by a dedication to applying her scientific expertise to enhance product development and market strategies. At Advanced Instruments, Sivane continues to contribute her knowledge and skills towards advancing the Cell Metric Portfolio, aiming to meet the evolving needs of the cell line development community with thoughtful and effective solutions.

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Who Should Attend?

This webinar will appeal to:

  • Scientists and Managers in CLD integrating automation into workflows
  • Professionals involved in GMP cell therapy manufacturing
  • Quality assurance and regulatory affairs experts
  • Biotech leaders seeking automation solutions for GMP-ready cell lines
  • Teams overcoming challenges in translating research to clinical applications

What You Will Learn

 Attendees will gain insight into:

  • Strategies for bridging the gap from research to GMP-compliant manufacturing
  • How automation and consultancy can streamline cell line development workflows and ensure compliance
  • Real-world case studies on regenerating cell lines under GMP requirements
  • Best practices for scalable tools and robust documentation in clinical translation

Xtalks Partner

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Advanced Instruments

Advanced Instruments is a global company offering a novel portfolio of analytical tools including, OsmoTECH®, a robust line of micro-osmometers to support bioprocessing and quality control (QC), and Solentim, a portfolio of 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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