Future Landscape of Flexible ATMP Facilities and Design Considerations
Complimentary
Learning Level: Intermediate
Time: 1000 - 1100 ET
Session Length: 1 hour
A powerful resource and approach to treat and cure debilitating diseases, that do not currently have medical regimens, is to engineer cell and gene sources into an ATMP that regenerates the tissue-organ system and/or cellular molecular machinery.
The ATMP market is projected to experience significant growth with various forecasts indicating a CAG-R of 16.25% - 27.94% from 2025 to 2034. The thrust for new facility requirements are additionally evident with 4,341 therapies in the pipeline of which 920 are cell therapies, 2,129 are gene therapies and 1292 are RNA therapies.
With the promise of ATMPs comes the associated challenges of sophisticated process development and optimizing the site design for autologous cell, allogeneic cell or viral gene product-types to handle multiple products, batches, changing pipelines and technologies, requiring future-proofing and regulatory standards for sterility and biosafety of operator and environment.
Technologies and trends shaping future facility design and space optimization for reducing footprint, process/product flexibility, future proofing, and costs are discussed. Landscape covering the vastness of ATMPs into few process attributes for guiding layout, utility and building attributes are delineated.
The review and insights presented are expected to assist attendees such as EPCM designers and subcontractors, ATMP manufacturers, regulators and equipment vendors to come up to speed with the current state-of-the-art in ATMP facility design, learn about the parameters and tools that are dictating decisions and competitive designs.
Learning Objectives
- Learn about the typical manufacturing technologies and processes that can be employed across the vast plethora of ATMPs in the pipeline.
- How to optimize flexible sites by incorporating interplay of process needs and design parameters such as:
- meet regulatory requirements for product integrity and safety with lean usage of highly classified areas
- continuous space utilization and operational logistics management
- future-proofing for changing pipeline products and manufacturing technologies
- New manufacturing technologies and Pharma 5.0 methods that will be evaluated and utilized for each new ATMP facility being built.
