Wednesday 11th March - Main Conference Day Two - PT (Pacific Time, GMT-08:00)
Case studies on compressing CLD timelines using intelligent automation and integrated platforms, demonstrating accelerated early CMC development while maintaining quality standards.
Presentations on how enhanced sensors, control strategies, and digital twins are driving process consistency and enabling continuous upstream operations.
Case studies detailing how companies are implementing continuous or hybrid manufacturing approaches, addressing technical, regulatory, and cultural considerations to improve efficiency and product quality.
Presentations on advanced purification technologies for complex biologics, including new affinity ligands, membrane adsorbers, and modeling approaches to streamline operations.
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 alternative host cells and expression platforms for complex biologics, discussing impacts on product quality, yield, and downstream processing compatibility.
Case studies detailing how ultra-high titers are achieved through cell line and process improvements, and how downstream operations must evolve to manage increased output.
Presentations on how companies are building agile manufacturing capabilities through cross-training, modular production suites, and real-time operational dashboards to drive responsiveness and efficiency.
Case studies demonstrating how downstream process decisions impact drug product stability and quality, underscoring the importance of integrated process development.
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.
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 – Accelerating Timelines vs. Ensuring Quality in CLD
Panel Discussion 2 – The Future of CLD – Automation, AI, and Novel Modalities
Case studies on adapting upstream processes for viral vectors, gene therapies, and other emerging modalities, with a focus on scalability and process robustness.
Case studies on how collaboration with regulators, use of emerging technology programs, and application of ICH Q12 tools enable manufacturing innovation while maintaining product quality and compliance.
Case studies on downstream solutions for CGT products, addressing unique challenges in impurity removal, cell viability preservation, and scalability for advanced therapies.
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.
Presentations on strengthening supply chains, qualifying alternative suppliers, and leveraging digital tools to build upstream operational resilience post-COVID-19.
A panel exploring how facility design and process strategies maximize sustainability, flexibility, and multi-product capabilities, including single-use systems and continuous bioprocessing.
Presentations on how companies condensed development and scale-up timelines for accelerated product launches by leveraging platform technologies, parallel development, and integrated DS/DP strategies.
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.
Presentations on incorporating real-time analytics and process control to enable faster product release, reduce cycle times, and support Bioprocessing 4.0.
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.