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

Sponsor

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

In an autologous run, there is one batch, one patient, and a release window measured in days. Confirmatory microbiological results do not always arrive inside that window, and QA release teams have to decide what the available data supports.

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:

At which points in the workflow, such as post-harvest, formulation, or final release, does the testing timeline force a decision before the result is available?
Which in-process signals carry enough weight to change a release decision, and which are only useful for investigation?
How do teams balance speed, patient timelines, and regulatory discipline?
How can rapid testing support investigations or parallel evaluation while adhering to regulatory expectations?

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.

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.