Approaching Process: Monitoring, Control and Effective Integration for Improved Quality
13:30am Chair Introduction
Chairperson: Amandine Breton, Director MSAT & AST, Cell & Gene Therapies, Orchard Therapeutics
13:35am Presentation: Productivity Improvements in Cell Therapy Manufacturing Processes
- Challenges in commercial manufacturing of first-generation cell therapies
- Improvement of productivity and unit costs without the need for process re-development using lean and digital tools
- Learning for development of next generation products
Frank Thielmann, Head Lean, Global Operational Excellence, Takeda
13:50am Presentation: Establishment of Commercial Lentiviral Vector Manufacturing Process Using QbD Approach
- Insights that help you choose the right CDMO
- A case study of QbD approach & the colossal role of it in the viral vector manufacturing
- Determining criticality – process parameters and quality attributes
- Working within the Design Space – parameter optimization
Susanne Kintscher, MS&T Lead Lentiviral Vector Manufacturing, Miltenyi Bioindustry
14:05am Presentation: Developing ATMPs for Commercialization: A large Pharma Process Approach from Idea to a Manufactured Cell Therapy Product
- AstraZeneca is investing in the potential of cell therapies across a broad range of serious disease areas affecting almost every part of the body with a focus on Oncology, Cardiovascular, Renal & Metabolism (CVRM) and Respiratory & Immunology (R&I) therapy areas.
- Working closely with experts across AstraZeneca and with external specialist networks are key pillars for the successful delivery of these innovative medicines.
- Manufacturing stands between the research of cell therapies and the eventual delivery of these medicines to patients and needs to consider both ends of product development, including biological and regulatory needs.
Elsa Abranches, Senior Director, Head of Cell Therapy Bioprocess Development and Manufacturing, BioPharmaceuticals R&D, Astrazeneca
Gabriella Nilsson Hall, Senior Scientist, Cell Therapy Bioprocessing Team, Astrazeneca
14:20pm Closing Panel with Q&A
With all session participants