Tuesday March 10Tuesday, 10 March 2026 - PT (Pacific Time, GMT-08:00)

Mammalian cell culture processes have been used for decades to produce therapeutic antibodies. These bioprocesses consist of costly reagents using cell lines with long doubling times and require aseptic conditions that often necessitate expensive single use equipment. The development of an Upstream process for commercial production also involves generation of numerous data sets to demonstrate process understanding and control. The result of these numerous challenges and requirements is that the development of a process takes 10-15 years with a cost of at least $100M. The reduction of timeline and cost has the potential to be achieved through use of computational tools that have matured greatly over the last several years. Machine learning based models of the cell culture production bioreactor have been developed with the goal of not only reducing the development load but also aiding in process prediction. Examples that highlight the potential of these tools are presented.

Achieving consistent, high-performance cell culture is fundamental to upstream bioprocessing, particularly for biologics manufacturing under accelerated timelines. This presentation introduces a comprehensive strategy for continuous optimization of an in-house developed Cell Culture Platform Media System (CCPMS), integrated with a comprehensive Quality Adjust Library (QAL) framework. The CCPMS provides a robust baseline for multiple host cell lines & product modalities, while QAL enables adaptive, data-driven refinement of media formulations to meet evolving process and product quality requirements.

Our approach leverages high-throughput experimentation and multivariate statistical modeling to identify critical nutrient interactions and optimize media composition for improved cell growth, productivity, and critical quality attributes (CQAs). The QAL acts as a dynamic repository of formulation adjustments, facilitating rapid iteration and knowledge capture across development cycles.

Case studies demonstrate significant gains in titer (≥ 10g/L), glycosylation consistency, and process robustness under tight timelines, highlighting the scalability and flexibility of this platform. By transitioning from static media design to a continuous optimization paradigm, CCPMS and QAL collectively enable faster development, reduced variability, and enhanced adaptability in a rapidly evolving biomanufacturing landscape.

Keywords: Cell culture media optimization, CCPMS, Quality Adjust Library (QAL), upstream bioprocessing, multivariate statistical modeling, continuous improvement

A forward-looking discussion on how manufacturing innovation, digitalization, and improved supply chains can expand patient access and to viable business cases.

• Develop risk-based and science-based analytical control strategy
• Considerations for assay development, qualification and validation
• Considerations for stability and shelf-life studies
• Common pitfalls & how to avoid them
  
  
  

• Introduction to Bridging Innovation and Commercialization in Cell and Gene Therapy Development
• Overview of Single-Use Systems in CGT Manufacturing – Product Claims, Compliance Testing, and Risk Mitigation Standards
• Overview of Ancillary Materials in Cell Therapy Manufacturing – Definitions, Regulatory Considerations, and Risk Mitigation Strategies