Upstream Processing

Mammalian Cell Line Development, Media and Metabolism

This session will feature various aspects of mammalian cell culture development aimed towards increased productivity, desired product quality, and enhanced process control. These aspects include cell line development, metabolic engineering, advanced bio-analytics, media development, multivariate process analysis, and innovative cell culture process development.
Topics of interest include:

• Host cell line development, novel clone selection methods, high-throughput screening strategies, semi-targeted and targeted integration, manipulation of non-coding RNAs, and vector engineering for improved production vectors
• Chemically defined media formulation for increased productivity, optimal product quality, and intensified manufacturing
• Metabolic engineering and pathway optimization
• Application of predictive modeling, AI/ML, metabolic flux analysis, and multi-omics (genomics, transcriptomics, proteomics, metabolomics, lipidomics)
• Preparation, storage, and management of raw materials including use of cost-effective raw materials, mitigating raw material variability, and managing changes in media components
• Driving sustainability in mammalian cell culture development to reduce the environmental footprint of bioprocessing

We especially encourage submissions that explore the interplay between mammalian cell growth and productivity, nutrient-enhanced media, and the physicochemical environment.

Advances in Complex and Emerging Modalities

This session will focus on the increasing prevalence of new and complex modalities for biologic drugs, and the innovative upstream manufacturing innovations needed to produce them.

Topics of interest include:

• Productivity improvements of emerging biologics
• Strategies to limit aggregation and clipping of complex biologics
• Approaches to control post-translational modifications within desired ranges
• Process innovations for bispecifics, trispecifics, fusion proteins, and antibody-drug conjugates (ADCs).

We particularly welcome submissions that achieve enhanced specificity, target multiple disease pathways simultaneously, or provide flexibility in mechanism of action, while maintaining desired stability, efficacy, and tolerance profiles.

Innovations in Intensified or Continuous Processes

This session explores the latest innovations in upstream process intensification and continuous biomanufacturing, driven by the growing demand for biologics and the need for more agile, cost-effective production platforms while maintaining high titers. Topics include high-density perfusion, hybrid and intensified fed-batch strategies, and novel innovations in bioreactor design and cell retention technologies. Emphasis will be placed on the integration of automation, PAT, and digital tools—such as digital twins, CFD, and process modeling—to enable predictive control and real-time optimization.

Topics of interest include:

• Perfusion and continuous upstream process development and implementation
• Bioreactor design, scale-up/scale-down models, and cell retention devices
• Media/feed optimization and cell line generation for continuous culture
• PAT-enabled control strategies and automation platforms
• Digital tools for process modeling, simulation, and facility design
• Case studies of intensified/continuous upstream process implementation, process economics, and regulatory considerations

We welcome contributions that demonstrate how these technologies are being applied to overcome challenges and unlock the full potential of continuous upstream biomanufacturing.

Strategies for Scale Up and Manufacturing

This session will showcase cutting-edge case studies and practical innovations that are shaping the future of upstream bioprocessing. As the industry is moving toward intensified and digitally-enabled manufacturing processes, this session emphasizes integrated solutions that enhance process scalability, process robustness, and product quality.
Topics of interest include:

• Resolution of complex challenges in upstream development, tech transfer, and manufacturing
• Challenges associated with product quality deviation at scale and mitigation strategies developed and deployed to mitigate them
• Development and qualification of predictive scale-down bioreactor models
• Bioengineering and bioprocess solutions to support consistent biomanufacturing productivity across scales
• Application of computational tools, including CFD and mechanistic modeling, to optimize bioreactor performance
• Deployment of upstream process analytical technologies (PAT) and real-time process control strategies
• Cost-effective process intensification and sustainability-driven upstream design
• Innovative harvest strategies to improve product purity and process efficiency

Case studies that demonstrate cross-functional integration—combining modeling, analytics, and process control—are especially encouraged.