Session Details

Chair:

• Michael Delahaye, EngD, AstraZeneca, Sweden

Speakers:

• Hollie Bartley, BSc, Resolution Therapeutics, United Kingdom - Scale out manufacture of autologous therapies: moving beyond early phase development
• Robert Zweigerdt, PhD, Hannover Medical School (MHH), Germany - Advanced manufacturing of hPSC-Cardiomyocytes and preclinical transplantation for heart repair in non-human primates
• Daria Donati, PhD, Cytiva, Sweden - Deliver what's next: Scaling the future of cell therapy

This concurrent session delves into the distinctions and strategic considerations associated with scale-up and scale-out approaches in the production of Advanced Therapy Medicinal Products (ATMPs). Participants will explore the nuances of the end-to-end bioprocess workflow, examining how each approach impacts efficiency, cost, and product quality. The session will also highlight innovative cell transformation techniques and their implications for scaling up, offering insights into how these advancements can optimize ATMP manufacturing.

Session Objectives

1. Understand key distinctions aligned with scale-up and scale-out strategies in ATMP production, including their respective advantages and challenges.
2. Explore how scalable approaches affect production and purification operations, focusing on implications for process efficiency, scalability, and regulatory compliance.
3. Learn about new methods in cell transformation and how they can be leveraged for effective scalable ATMP manufacture.
4. Assess Impact of different scaling strategies in ATMPs quality, consistency and cost-effectiveness.
5. Identify emerging technologies and methodologies that hold promise for enhancing scalable processes in the context of ATMP development.