Scaling Up Your Manufacturing & The Capacity Crunch – How Are We Making Room for The Therapies of the Future?

06 Sep 2023
16:00
Stream 1
SPONSORED BY
Catalent Cell & Gene Therapy
ScaleReady

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  • The majority of cell culture methods still rely on radically outdated philosophy and complexity and therefore programs face unnecessary and expensive consequences when they neglect to adapt to simplification and elimination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

  • Brownfield  
  • CAR-T  
  • 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 

 

Speakers

Volker Huppert
Chief Development Officer
GlycoStem
Juliana Pinto
Head of GMP CAR T Production, Centre for Cell, Gene and Tissue Therapeutics, NHS Royal Free Hospital
UCL
Jenny Stjernberg
PhD, Director, Commercial Operations EMEA
ScaleReady
Sarah Snykers
Senior Director of Operations Europe
Legend Biotech
Jessica Berlier
Director P&AD
Catalent Cell & Gene Therapy