Program

Half a Century of Progress: From Cells to Solutions ……… and beyond

After 50 years of development and progress in bioprocess technology and applications of animal cells for health and research, in this year’s ESACT MEETING we aim to address the newest advances in this field relating both to research and biomanufacturing. Below you find a list of topics that we would like to address under the overarching theme of understanding the cellular mechanism and the industrial exploitation of cells as factories of proteins, vaccines, cell therapies and as vectors for delivery of gene therapies or any other animal cell-based products.

1. Computational and Digitalization Frontiers – From Prediction to Production

Chairs: Nathan Lewis and Dong-Yup Lee

As therapeutic molecules become more complex, it becomes a challenge to capture the complexity of the multifaceted interactions between molecules, cells, products, and bioprocesses, requiring innovative solutions in the design and engineering of cell factories and biomanufacturing. This session explores the transformative power of computational tools, artificial intelligence, machine learning, systems biology, and the data infrastructure underpinning these approaches, bridging the gap between research and manufacturing. By embracing advances in computational tools and big data, this session envisions a fully integrated, predictive manufacturing ecosystem. This session may include, but is not limited to:

• predictive modelling of molecular interactions
• establishment of robust big data ecosystems to enable rapid, reproducible, actionable, and cost-efficient solutions.
• cutting-edge innovations such as virtual cell models, LLMs, and actionable omics that enable smarter decision-making and data sharing across researchers and industries.
• In silico design of drug molecules, production cells, and manufacturing platforms.
• AI, ML, and hybrid models for predicting molecular interactions, cell responses, and drug manufacturability.
• Data-driven decision-making through actionable omics and big data sharing.
• Generative AI for accelerating solution discovery
• Digital twins for biomanufacturing optimization
• High-throughput data generation, big data analysis, and diverse data integration

2. Engineering Tomorrow’s Cell Factories

Chairs: Mike Betenbaugh and Johan Rockberg

In this session, we will explore and expand the opportunities and challenges in producing standard and novel therapeutics using animal cells. Through visionary scientific and engineering strategies, we seek to harness cells, organelles, pathways, and gene expression patterns to meet the demands and reach new heights in biopharma production

Topics of interest include but are not limited to:

• Engineering pathways, PTMs, secretion and organelles
• Advances in synthetic biology such as gene expression, regulation, and control
• Production of new modalities such as multispecifics and viral vectors
• Expression of de novo synthetic proteins
• Systems biology and epigenomics
• Data-driven cell design and machine learning techniques to improved cell formats
• Vector engineering, artificial chromosomes, genome editing, and transposase-mediated or other gene integration techniques
• Minimal cells
• improving productivities and refining cell line stability
• HTP screening and automation
• Accelerated product development – shortening time from design to patient
• Drug-conjugates and introduction of non-canonical amino acids
• Cell free synthesis
• Streamline regulatory compliance for current and next-generation therapeutics

3. Analytics and Automation

Chairs: Veronique Chotteau and Till Wenger

Analytical Methods are a prerequisite for product understanding and process monitoring, as well as control and automation through PAT. Despite considerable progress over the last decades, there is still, and more than ever, a need for meaningful, fast, and reliable methods, as well as automation of analytics and data processing. Over decades, process robustness has been favored compared to implementation of feedback control strategies, which require validated real-time analytics and control. Will this continue or will new applications become an industrial reality and for which type of biologics? We invite presentations in the fields of protein production, vaccines, gene therapy vectors, cell therapy, etc. about the following (but not restricted to): 

• New analytics for faster, more actionable insights, especially for complex biologics, cell and gene therapeutics
• Advanced PAT systems for real-time process automation, monitoring, and control
• Disruptive technology for sensors and feedback loops
• Defining, understanding, monitoring and controlling CQAs for complex biologics.
• Dealing with the variability of starting materials to achieve robustness in cell therapy manufacturing
• Regulatory aspects of novel methods and process control strategies
• Acceleration potential through automation, better product and process understanding
• PAT and digital twin to support manufacturing
• Case studies of implementation of PAT in commercial biomanufacturing
• Examples of accelerated or real time drug substance release based on novel methods or PAT

4. Sustainable Bioprocessing – Greener and Affordable Biomanufacturing

Chairs: Oliver Rupp and Antonio Roldao

This session explores the vital intersection of sustainability, affordability, and efficiency in biomanufacturing. It aims to spotlight innovative, scalable, and economically/environmentally viable solutions to address the challenges of modern bioprocessing. These advancements are expected to make bioprocessing more eco-friendly and accessible, while also meeting the growing demand for biologics and further innovative cell culture applications. Ultimately, these innovations should help ensure that new therapies and products reach patients and markets faster. We are focusing on spotting advances in bioprocessing technologies to revolutionize biologics production (e.g. recombinant proteins, vaccines), accelerate cell and gene therapy applications, and drive innovation in cultured food and meat solutions. This includes, but is not limited to:

• Streamlining the interface of upstream and downstream processing operations
• Transitioning to continuous or hybrid manufacturing
• Incorporating renewable resources and innovative ways of “reutilizing” process components into production pipelines
• Cross-project and –product learnings to simplify and expedite process scalability, validation activities, and technology transfers
• Reducing production facilities footprints through balanced scale utilization and flexible, modular unit operations (e.g. container-sized “Mini Factories”)
• Standardizing manufacturing platforms to accelerate the development and approval of new therapies and products

5. Expanding the Horizons of Animal cells – new applications and therapeutic formats

Chairs: Margarida Serra and Nick Timmins

Bringing together insights from cell and developmental biology, immunology, materials science, biofabrication, bioprocessing, and data sciences, this session delves into groundbreaking applications of animal cells. Key discussions will focus on overcoming manufacturing and economic challenges, unraveling mechanisms of action, improving potency and addressing immuno-compatibility for therapeutic uses, and ensuring safety in both therapeutic and non-therapeutic applications. The session will also explore the practicalities of transitioning innovative concepts from research to real-world applications, including regulatory considerations for these emerging technologies.

Topic examples:

• Advancements in organoid/assembloid technology and micro-physiological systems as tools for drug testing, disease modeling, and reducing reliance on animal testing.
• Enabling affordable and accessible cellular medicines and engineered tissues/organs
• Next generation cell factories for complex secretory products (e.g., extracellular vesicles and implantable delivery devices)
• Animal cells as information processors: biosensors and computational systems
• Making cellular agriculture feasible: cultured meat, cells as food ingredients, and cell-cultured materials.

6. Disruptive Technologies and Visionary Frontiers

Chairs: Nicole Borth and all

This session focuses on revolutionary innovations and ideas shaping the future of animal cell technology. With visionary keynotes from pioneers across diverse fields, this session seeks to inspire bold new directions for research and biomanufacturing. On purpose we do not restrict the topics that can apply, but we are looking for ideas that have highly disruptive or innovative potential.