Upstream Processing
Five different sessions are available for abstract submission.
Challenging Modalities
Complex modalities of biologic drugs have become increasingly prevalent, aiming to address the diverse and intricate needs of diseases such as cancer, autoimmune disorders, genetic conditions, and viral infections. As our understanding of the exact mechanisms of these diseases deepens, we strive to design modalities that offer enhanced specificity, target multiple disease pathways simultaneously, and provide flexibility in their mechanisms of action, all while maintaining desired stability, efficacy, and tolerance profiles. However, these complex modalities present unique challenges in their manufacturability using established platform processes. This session calls for innovative approaches in upstream processing to address these manufacturability issues. Examples include, but are not limited to, upstream strategies to improve productivity, limit aggregation and clipping, control post-translational modifications within desired ranges, modify media raw materials, and efficiently scale up for bispecifics, trispecifics, fusion proteins, and antibody-drug conjugates (ADCs).
Integrated, Intensified & Continuous Processes
In the last decade, technical advances in both upstream and downstream bioprocessing have led to the advent of innovative technologies and exploration of integrated continuous biomanufacturing (ICB). As demand for biologics increases, continuous manufacturing is becoming an attractive choice for process intensification of relatively stable products such as monoclonal antibodies and vaccines. Compared to the current fed-batch processes, ICB technologies and platforms can offer higher productivity, while reducing manufacturing footprint, capital investment, and operational costs. However, there are still numerous challenges with implementing ICB technologies and platforms. This session will encompass advances in upstream perfusion and continuous processing, including advances in process development, process characterization, media development, bioreactor design and engineering and cell retention devices, scale-up/scale-down model development, cell line engineering/adaptation, modeling and computational approaches, implementation in manufacturing spaces, process and facility economics, and any case studies related to ICB technologies.
Innovative Technologies in Automation, Digitalization, and Modeling
Successful and rapid development and commercialization of biotherapeutics significantly depends on novel technologies that can improve study throughput, data capture, data analysis, and process prediction from identifying the final cell line (clone) to commercial manufacturing. In recent years, enhancements in laboratory automation coupled with high throughput (HT) analytics have led to fully automated cell culture development workflows that have the potential to significantly expand development capacity and capabilities to support both traditional and advanced therapeutic modalities. However, to fully leverage these systems and the huge amount of data they generate, innovative digital tools that streamline laboratory processes, data analysis, and data visualization are needed. Progress in artificial intelligence, machine learning, and other computational methods are being developed and implemented to harness the multidimensional data sets generated during HT upstream process development to drive informed process decision-making and cross-program learning/knowledge management. This session will explore advances in automation and digitalization concepts, tools, and applications that support cell culture process development and characterization. Process models developed using methods including machine learning algorithms, mechanistic, and/or hybrid approaches that are used for cell culture process optimization, media development, process troubleshooting, performance prediction, and process control will also be included. Finally, this session will foster a discussion on the user’s experience and the next steps and processes to enhance the application and outcomes of these innovative technologies.
Case Studies of Development, Scale Up, and/or Manufacturing
This session will highlight cutting-edge case studies that demonstrate recent innovations and advancements in upstream process development and manufacturing. Topics of interest include, but are not limited to:
• Troubleshooting and resolving unexpected challenges in upstream process development, technology transfer, and manufacturing
• Strategies to control charge variant and glycosylation profiles
• Development, qualification, and application of bioreactor scale-down models
• Utilization of computational modeling and digital tools in upstream process development, including computational fluid dynamics
• Implementation of upstream process analytical technology (PAT) for enhanced bioreactor control
• Cost reduction strategies in upstream processes
• Novel approaches to bioreactor harvest ensuring cell or product purity
Case studies that integrate multiple areas listed are encouraged, showcasing comprehensive solutions and multi-faceted approaches to common and emerging challenges in the field.
Mammalian Cell Line Development, Media, and Metabolism
Mammalian cell culture is crucial for producing viral vaccines, recombinant proteins, monoclonal antibodies, and biopharmaceuticals. The rise of cell-based and gene therapies, involving cells or viral capsids encoding genes of interest, further emphasizes the need for optimal culture conditions. The interplay between mammalian cell growth, nutrient-enhanced media, and the physicochemical environment has matured the field into a multi-disciplinary collaborative effort including advancements in genetic manipulation, medium and feed development, bioreactor characterization, and process control to enhance productivity, product quality, and other interrelated areas. This session covers various aspects of mammalian cell culture development, including improved production vectors, novel clone selection, host cell line engineering, cell expansion strategies, metabolic pathway analysis, media development, multivariate process analysis, and innovative cell culture process development. Relevant papers are encouraged, particularly those on cell line development, vector engineering, medium optimization, preparation, storage and chemistry, metabolic engineering, modeling, ‘omics analyses, and management of raw material changes in media components.
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