Thursday 20th March - Main Conference Day TwoThursday, 20 March 2025 - PT (Pacific Time, GMT-08:00)

Poloxamer 188 (P188), an amphiphilic polymer, is widely used for its protective effects on mammalian cells exposed to shear stress in bioreactor environments. These effects arise through both direct intracellular and membrane interactions, as well as indirect extracellular mechanisms, such as bubble coating to mitigate cavitation forces. Recent studies suggest distinct functional differences between commercially available grades of P188 (Kolliphor P188 Bio and Kolliphor P188 Cell Culture), driven by variations in molecular weight distributions. This study investigates the direct effects of bio-grade and cell culture grade P188 on cell membrane properties and metabolism. Our anisotropy analyses indicates that both grades of P188 enhance membrane rigidity, potentially through distinct sphingolipid profiles revealed through lipidomic studies. Cell culture grade P188 upregulates glycerolipids and their precursor, glycerol-3-phosphate, more significantly than bio-grade P188. Differences in ceramide and glycerolipid regulation may correspond to distinct impacts on anti-apoptotic mechanisms and shear stress protection. Indirect effects were studied through growth profile analyses in baffled flasks and fed-batch bioreactors. Culture grade P188 enhanced productivity and showed grade-specific responses to nutrient uptake and shear stress protection. Our findings reveal that different P188 grades exert distinct impacts on both direct and indirect cell culture performance. To optimize bioprotective outcomes, we recommend carefully selecting the appropriate P188 grade based on process conditions, such as micro-sparging and cell line-specific requirements.

• Ensuring the commercial sustainability of cell & gene therapies;
• Tackling barriers and identifying opportunities for commercialization;
• Innovative payment models in the US and globally;
• Strategies for attracting investment to ensure smooth transition from bench to bedside.
• Innovation driving improved commercialization.

Maintaining desired product quality (PQ) during the manufacture of biologics is an area of increasing interest due to their impact on drug efficacy. During drug development, various attributes such as glycosylation may be identified as critical quality attributes (CQA) that must be controlled to achieve the desired PQ. It is important for upstream scientists to understand how to effectively utilize processing parameters as levers to modulate CQAs. This presentation will focus on how various levers impact the CQAs of multiple programs.

To enable electrostatic-steering strategies as a molecular format of multispecifics, Pfizer has developed a co-culture strategy to produce both homodimers in cell culture simultaneously, and subsequently applying the mixture to the redox reaction for heterodimerization during the protein A chromatography unit operation.

Co-culturing introduces exciting new scientific challenges. Careful balancing of cell line performance is needed, as each cell line’s performance during production can greatly impact the excess homodimer impurity profile. Unexpected manufacturing deviations could impact ratio of homodimers produced. These challenges are considered and explored to enable a robust co-culture process, which has been successfully executed for clinical manufacturing.

Computational bioprocess models are powerful tools for improving decision-making throughout the bioprocess lifecycle, from early development to late-stage optimization, scale-up, product launch, and continued process verification. This talk will explore how hybrid-model-powered cell culture simulation enhances predictive decision-making, deepens scientific understanding, and enables rapid in silico iteration. Case studies will illustrate the application of a single hybrid cell culture model that integrates explicitly defined factors—such as bioreactor characteristics, mass balance, mass transfer, chemical equilibrium, and control strategies—with implicitly defined aspects like cell metabolism and product synthesis. These examples will highlight the broad utility of hybrid models and demonstrate how scientists can leverage simulation to refine decision-making, accelerate R&D timelines, reduce physical experiments, and improve process robustness.

• CDMO Landscape:
  • Benefits of partnering for facility design, equipment selection, etc.
• Key Selection Criteria:
  • Identifying and prioritizing the important factors to consider when selecting a partner within downstream.
• Approaching Tech Transfer and Best Practices;
• Real-world experiences of successful facility fit-outs and collaborations that have led to improved efficiency, reduced costs, and enhanced product quality.

• CDMO Landscape:
  • Benefits of partnering for facility design, equipment selection, etc.
• Key Selection Criteria:
  • Identifying and prioritizing the important factors to consider when selecting a partner within downstream.
• Approaching Tech Transfer and Best Practices;
• Real-world experiences of successful facility fit-outs and collaborations that have led to improved efficiency, reduced costs, and enhanced product quality.

Join Thermo Fisher Scientific to learn the pathway to sustainable manufacturing at Booth #614

Almost every biopharmaceutical company, regardless of size will engage with one or more contract manufacturer(s) during their drug development journey. Work packages executed at CDMOs not only deliver key materials and data, but also are major contributors to the overall budget and timeline. Identifying the right CDMO(s), and building strong partnership(s) can make or break a clinical development program. This session will provide actionable advice, and tools for selecting the right CDMO, establishing a robust foundation and managing the relationship with the selected CDMO, to set the program up for success. Furthermore, strategies to anticipate and eliminate potential challenges and conflicts to ensure seamless integration of interdependent activity packages at multiple CDMOs will also be discussed.

Tiago Matos, Associate Principal Scientist, Merck

Explore groundbreaking research, meet the poster presenters and BPI Editors, plus find out who has won the poster competition (a free ticket to next year's event!)

*Industry /Academic Posters SOLD OUT*

Embarking on a biotech career can be both exciting and daunting. Join Biotech Connection Los Angeles at BioProcess International US West for an engaging panel featuring early-career professionals who have successfully navigated this path. Hear their reflections on the obstacles they encountered, the insights they gained, and the strategies they used to excel in a competitive field.

This discussion will explore essential topics such as building a professional network, positioning your research experience in an industry setting, and developing the soft skills crucial for success. Attendees will walk away with practical, real-world insights and actionable steps to accelerate their own journeys in biotech. Whether you’re a graduate student, postdoc, or new industry hire, don’t miss this opportunity to learn directly from those who have already taken the first steps toward industry success.

• Implementing next-generation technologies, including AI/ML-powered tools, for optimized efficiency;
• How can you seamlessly incorporate technologies?
• Where do we think manufacturing technology is heading in the next 5-10 years?

Talk 1: Driving digital innovation for supply chain orchestration in cell and gene therapy

Christian Fuchs, Head of Orchestration and Exceptions Management for Cell & Gene Therapy (CGT) at Roche/Genentech, USA

Talk 2: Therapeutic epigenome editing: safety and quality considerations of a new class of gene-targeted medicines

Houria Bachtarzi, Principal Consultant, Founding Director, BIOCELLGENE Consulting Ltd, UK