Wednesday 11th March - Main Conference Day Two - PT (Pacific Time, GMT-08:00)
Presentations on optimizing viral vector production for gene therapies, focusing on high-yield processes, transition to suspension systems, and strategies for consistent product quality.
Presentations on compressing development timelines using platform technologies, parallel development, and integrated DS/DP strategies. Talks will highlight how analytics and AI-supported risk assessments enable rapid scale-up.
This session will highlight strategies and technologies that address the unique challenges of GLP-1 product recovery and purification, including high-volume production demands, process economics, impurity clearance, and regulatory expectations. Case studies will explore how biopharma innovators are optimizing chromatography, crystallization, and membrane separations to meet growing commercial demand while ensuring product quality, safety, and supply reliability.
Case studies demonstrating how digital platforms, logistics coordination, and scheduling algorithms are improving vein-to-vein times and overall supply chain reliability for autologous therapies.
- Vilas Shukla, Ph.D. - Director, Large Molecule Global Engineering Projects, Johnson & Johnson Innovative Medicine
Gain a deeper understanding of the key factors and hear potential solutions to ocercome the key challenges cell line development and engineering.
Panel Discussion 1 – Preparing for Commercialization of Advanced Therapies
Panel Discussion 2 – Future Directions – Making Cell & Gene Therapies More Accessible
Case studies on how early collaboration between CLD and process development teams improves scale-up predictability and tech transfer success.
Industry and regulatory experts will address how CLD can be designed to anticipate lifecycle changes, comparability, and commercial scalability, with emphasis on drug substance and drug product integration.
Best practices for maintaining genetic stability and ensuring consistent quality. Panelists will discuss digital monitoring and AI-enabled risk prediction across development to commercial stages.
A panel exploring how facility design and process strategies maximize sustainability, flexibility, and multi-product capabilities, including single-use systems and continuous bioprocessing.
A visionary discussion on trends shaping the future of biomanufacturing, including decentralized production, autonomous operations, evolving supply chains, and integration of continuous end-to-end processes.
A panel exploring how facility design and process strategies maximize sustainability, flexibility, and multiproduct capabilities. Discussions will include modeling and digital tools to enable agile facility operations.
Forward-looking discussion on how continuous processing, single-use technologies, and AI-driven purification systems will transform downstream operations by 2030.
Presentations on formulation, cryopreservation, and fill-finish strategies to ensure CGT product stability, safety, and effectiveness at the final drug product stage.
Panelists will discuss scaling CGT processes for launch, including validation, comparability, COGS, and supply chain readiness. Focus on digital readiness for regulatory filings and scale-up.