Improving manufacturing reliability in cell and gene therapy: practical operational strategies

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

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Improving manufacturing reliability in cell and gene therapy: practical operational strategies

Gain practical insight into how to improve manufacturing reliability, reduce cost per batch, and strengthen performance in cell and gene therapy programs. This webinar will demonstrate how structured assessment of materials, process steps, testing workflows, and operational handoffs reveals actionable opportunities to shorten timelines and reduce variability.

Using real-world examples and techniques that can be applied across multiple therapy types and development stages, the session will show how early operational assessment and targeted workflow adjustments lead to measurable improvements. These include smoother transitions into GMP manufacturing, fewer late-stage process changes, and sustained success during routine production.

Key takeaways

Learn how mapping the current state of a manufacturing program across materials, unit operations, testing, and handoffs reveals actionable opportunities to reduce cost, minimize variability, and improve right-first-time statistics
Understand how standardized workflows combined with expertise support smoother transitions into GMP manufacturing and reduce late-stage process changes
Review generalized case examples demonstrating reductions in cost per batch, improved manufacturing reliability, and sustained success during routine production
Gain a practical framework for evaluating your own program, identifying improvement priorities early, and working with partners to optimize processes without disrupting timelines

Francesca Vitelli

Vice President, Global Head of Process, Analytical Development and Innovation at Minaris Advanced Therapies

Francesca Vitelli, PhD, is a biotechnology leader with more than 20 years of experience in process and analytical development, manufacturing, and CMC strategy across cell and gene therapies. At Minaris Advanced Therapies, she leads global teams responsible for advancing innovative, platform-based manufacturing solutions for cell therapies and viral vectors, with a focus on de-risking CMC execution, enabling reliable GMP delivery, and accelerating the adoption of new technologies to improve scalability, robustness, and patient access.

Previously, Dr. Vitelli served as Vice President at Intellia Therapeutics, where she led process development and manufacturing for both in vivo and ex vivo gene editing programs, expanding technical capabilities while driving operational efficiencies. Prior to Intellia, she held senior leadership roles at Lonza, where she launched large-scale viral vector manufacturing platforms and led cell therapy manufacturing for clinical and commercial-ready programs.

Dr. Vitelli is recognized for her technical rigor, innovation-driven mindset, and ability to scale organizations through periods of rapid growth. She holds a PhD from the University of Siena.

In 53 Days

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