Scaling Up Your Manufacturing & The Capacity Crunch – How Are We Making Room for The Therapies of the Future?
16:00pm Chair Introduction
Chairperson: Volker Huppert, Chief Development Officer, GlycoStem
16:05pm Presentation: Translation of CAR T Products into Phase 1 Academic Trials: The Experience of the UCL CAR T Programme.
- Set up of a manufacturing platform for academic CAR T trials
- Translation of early research developments into clinical products
- Challenges faces by academic teams for the development and delivery of cell and gene therapies
Juliana Dias Alves Pinto, Head of GMP CAR T Production at the CCGTT, UCL & NHS Royal Free Hospital
16:20pm Presentation: Successful Scaling Up, Out and Down Ensuring Supply Chain Security and Rapid Accessibility for Patients Through Simplified and Standardized Manufacturing
- The majority of cell culture methods still rely on radically outdated philosophy and complexity and therefore programs face unnecessary and expensive consequences when they neglect to adapt to simplification and elimination before automation
- The criticality of creating simplified, standardized and repeatable consistent processes that ensure linear scale up and out as well as down to meet patient demand
- How closing the gap between clinical bench to patient bedside with reliable, consistent cost-effective cell therapy tools and resources can impact a patient’s accessibility to life-saving treatments faster.
- The importance of the often-misunderstood role that process optimization experts have in your success. The road to faster reliable, successful therapies also involves partner companies that are much more than transactional.
Jenny Stjernberg, Director, Commercial Operations EMEA, ScaleReady
16:35 Presentation: Legend Biotech: creating a global CAR-T manufacturing footprint
- GMP production facility
- Tech Transfer
Sarah Snykers, Head of Operations Europe, Legend Biotech
16:50pm Presentation: Plug-and-Play Platform to Lock your CAR-T Cell Therapy Process and Speed your Path to Clinic
- Developing closed, controlled and automated processes for CAR-T therapies remains a challenge
- Catalent’s fully closed GMP compliant CAR-T cell platform uses data-driven guidance to build a seamless, robust, modular workflow for both autologous and allogeneic cell therapies, minimizing risk without compromising on quality.
- Learn more about Catalent’s UpTempoSM CAR-T Cell Therapy Platform
Jessica Berlier, Director P&AD, Catalent Cell and Gene Therapy
17:05pm Closing Panel with Q&A
With all session participants