Cell therapy manufacturing without late surprises: contamination risk, QC timing, and patient-specific workflows

Wednesday 08:00 PDT / 11:00 EDT / 16:00 BST / 17:00 CEST

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Cell therapy manufacturing without late surprises: contamination risk, QC timing, and patient-specific workflows

Where do microbial testing timelines collide with manufacturing decisions, and which contamination signals can you trust before a release decision is made?

This expert panel brings together manufacturing, QC, and QA release perspectives to explore how teams balance speed, patient timelines, and regulatory discipline across cell therapy production. You will gain practical, real-world insight into sample point selection, rapid testing controls, and staged evaluation strategies for autologous and allogeneic workflows.

Key questions the panel will tackle include:

Where do microbial testing timelines most often collide with cell therapy manufacturing decisions?
What contamination signals are most useful before final release decisions?
How do teams balance speed, patient timelines, and regulatory discipline?
How can rapid testing support investigations or parallel evaluation without overclaiming?

Diana M. Colleluori, PhD MBA

Principle CMC Consultant at Biologics Consulting

Accomplished Executive Leader with 25 years of domestic and global experience in analytical methods, quality control, CMC regulatory affairs, and strategic planning in both start-up and growth organizations focused on biotechnology products, including cell and gene therapy products. Key technical experience includes potency assays, release and characterization assays, stability, specifications, and raw materials. Previous head of Quality Control for several innovator companies including Iovance Biotherapeutics, bluebird bio, and Merck. PhD in Biochemistry from Temple University School of Medicine and MBA in Pharmaceutical and Healthcare Business from the University of the Sciences in Philadelphia.

Sharon Barkatullah, PhD

Head of Analytical Development at Cell and Gene Therapy Catapult

Sharon Barkatullah, PhD is Head of Analytical Development at the Cell and Gene Therapy Catapult. She leads a team of analytical scientists dedicated to overcoming analytical challenges and advancing analytical characterisation strategies for cell and gene therapies. With over 25 years of experience in analytics and CMC across the biotech and biopharma sectors, she has built extensive expertise. Within CMC she led analytics projects to bring novel cell replacement therapy products into clinical trials. She graduated from Queen’s University Belfast with a first-class honours’ degree in Biomedical science and a PhD in neuroendocrinology. She also graduated with distinction from King’s College London with an MSc in Applied Neuroscience.

Seth Peterson

Senior Manager of Application Scientists at Thermo Fisher Scientific

Seth Peterson is a seasoned professional in the field of pharma analytics. With a dedicated focus on supporting and advancing novel genomic methods. In his capacity at Thermo Fisher, Seth oversees application support initiatives, playing a crucial role in developing and implementing innovative genomic methods tailored for both research and regulated environments within the pharmaceutical industry.

In 43 Days

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