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.
- Analytical Testing ,
- Bioanalytical Testing ,
- Biologics Manufacturing ,
- Biomanufacturing ,
- Cell & Gene Therapies ,
- Cell Line Development ,
- Cell Therapy ,
- Cell Therapy Manufacturing ,
- Commercial Manufacturing ,
- Drug Development ,
- Drug Manufacturing ,
- GMP ,
- Laboratory Technology ,
- Manufacturing ,
- Osmolality ,
- Other Research ,
- Quality ,
- Translational Research
Speakers
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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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, 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.
Message Presenter
Camilla Domeneghetti, Biology Manager, Advanced Instruments, LLC
Camilla Domeneghetti has the position of Biology Manager — Cell Line Development at Advanced Instruments, based in the UK. Camilla has a master’s degree in molecular biology and an undergraduate degree in biological sciences. As part of the Applications team, her role includes overseeing the validation and optimisation of the Solentim portfolio of technologies that improve cell line development and cell therapy workflows. In addition, her role involves improving the use cases and applications of these technologies to support Advanced Instruments customers.
Message PresenterWho 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
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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