Tuesday 10th March - Main Conference Day One - PT (Pacific Time, GMT-08:00)
Presentations on novel engineering strategies, such as targeted gene integration and transposase-based systems, to enable expression of complex biologics. Speakers will demonstrate how these approaches accelerated development timelines and improved productivity without compromising product quality.
Presentations on applying AI and predictive models to optimize cell culture processes, improving productivity and maintaining product quality.
Case studies detailing how companies leveraged standardized platforms, early risk assessments, and digital knowledge management to ensure seamless tech transfer across global manufacturing sites, aligning with supply chain planning and regulatory expectations.
Case studies on optimizing purification processes to manage high upstream titers, including new capture methods, improved resins, and process adjustments to maintain product quality.
A high-level overview of CGT market trends, manufacturing challenges, and regulatory updates, providing context for the technical discussions that follow.
Case studies showcasing the use of automation and machine learning to rapidly screen and select high-producing cell clones. Presenters will highlight how AI-driven models shortened development cycles and improved clone selection accuracy.
Case studies on managing raw material variability through supplier partnerships and advanced analytics to strengthen supply chain reliability and process consistency.
Presentations on how biomanufacturers have strengthened raw material and single-use supply chains post-COVID-19, through supplier diversification, inventory management, and digital tools for real-time visibility and risk mitigation.
Presentations on implementing continuous downstream technologies and enablers to improve efficiency, reduce footprint, and enhance product consistency.
Exploration of next-generation gene editing platforms such as Cas-CLOVER and advanced CRISPR systems for enhancing industrial cell line development, with an emphasis on integration efficiency and freedom-to-operate.
Presentations on media and feeding strategies to support intensified processes, improve cell densities, and enhance titers without compromising product quality.
Case studies demonstrating how digital twins of biomanufacturing facilities are enabling process optimization, debottlenecking, predictive maintenance, and enhanced production scheduling.
Case studies on purification strategies for viral vectors, focusing on impurity removal and achieving drug product quality for gene therapies.
Presentations showcasing how automation and closed-system processing are improving consistency, efficiency, and chain-of-identity tracking in autologous cell therapy production.
Presentations on applying machine learning and multi-omics data integration to predict cellular behavior, optimize media, and enhance clone selection for improved titer and quality.
Industry experts will share best practices for maintaining genetic stability, managing cell banks, and ensuring consistent product quality from early development through commercial manufacturing.
Case studies demonstrating how advanced PAT tools enable real-time monitoring of critical quality attributes, supporting Bioprocessing 4.0 and continuous processing.
A practical discussion exploring trade-offs, operational challenges, and product-specific considerations when adopting continuous or fed-batch processes.
Presentations on retrofitting legacy facilities for gene therapies, mRNA vaccines, and other advanced modalities, with emphasis on modular designs, single-use systems, and digital infrastructure to enable multiproduct flexibility.
A discussion on practical strategies to implement AI, digital twins, real-time data systems, and automation in biomanufacturing, highlighting both success stories and challenges in workforce adoption and cultural change.
Case studies addressing supply chain vulnerabilities for critical purification materials, including real-world examples of qualification of alternative components and regulatory strategies.
A panel exploring how automation, PAT, and data integration are revolutionizing downstream operations, enhancing efficiency, consistency, and regulatory compliance.
Case studies highlighting analytical and QC strategies for CGT products, including rapid potency testing, impurity monitoring, and chain-of-identity management for autologous therapies.
A comparative discussion on the unique manufacturing, supply chain, and scalability challenges of autologous (patient-specific) and allogeneic (universal donor) cell therapies.