Scientific Programme

Preliminary Scientific Programme

Please Note: Programme sessions and timings may change over the coming weeks

Room – Pentland Auditorium

Session Theme Descriptions

Cells as factories and therapies: modernizing biologics production for emerging modalities

Cell culture is the key to the manufacture of protein-based (biopharmaceutical, non-mRNA vaccines), viral gene and cell-based therapies. Manufacturing challenges exist around the capacity of mammalian cells to support the generation of novel therapeutic modalities (e.g. domain-engineered proteins) and gene- and cell-based therapies (e.g. CAR-T cells). The yields and quality of emerging modalities can be limited by a lack of the fundamental understanding of product interaction and influences upon the capacity of cells to produce the target therapy. To generate innovative products at the scale required to enable realisation of their therapeutic potential requires a molecular and cellular understanding of how the cell factory is influenced by the molecular interventions. Such understandings will aid development of enhanced processes, cell factory hosts and, in certain cases, potential replacement of cell-based manufacture by cell-free systems.

In this session we seek to examine current understanding of the potential for manufacture of a range of engineered and emerging modalities (such as multi-domain antibodies, antibody-drug conjugates, hard-to-express proteins, non-mRNA vaccines, viral-based gene therapies, modifies [CAR-T, NK, etc] and non-modified cell therapies, including both allogenic and autologous systems). In particular, we are looking for contributions that will exemplify the development of understanding through which cells, products and/or processes can be engineered to improve efficacy, economy and safety of emerging entities, and which identify means to predict successful enhancement of production of therapeutics of novel structure and function.

Product Quality – Functional Relevance and Emerging Technologies

Ensuring consistent high product quality has been an integral part of process and product development and this extends well into commercial manufacturing, testing, and product release. While relationships between product quality attributes and in vivo product function have always been foundational, the need for improved understanding of these relationships has intensified with the emergence of novel modalities both as complex expressed proteins and more specifically cell and gene therapy-based therapeutics. Additionally, health authorities across the globe are increasingly expecting rigorous science-based understanding of product quality attributes as part of regulatory filings, both during manufacturing and release of biological drugs.

In this session, we wish to explore the complex relationships between product quality attributes and their impact on product function. Recognizing the modality-specific nature of such relationships, we wish to broadly explore the modality space and are especially interested not only in complex protein-based drugs but also in emerging modalities such as cell and gene therapy. Novel analytical technologies and PAT are playing an increasingly important role in attribute understanding and will also be explored in this session.

Transitioning from development to manufacture - How do science and innovation translate into highly efficient biomanufacturing?

Process knowledge is gained throughout early development efforts and often successfully built into advanced biomanufacturing platforms. The objective of this scientific session is to consider strategies which help to accelerate process development and tech transfer with a high level of confidence. The smart integration of predictive models and novel experimentation strategies are used to fine tune the desired product quality and enhance process control at manufacturing scale. As a result, more cost efficient, robust and scalable bioprocesses are established to support the production of biologics and vaccines, as well as a variety of new therapeutic modalities. But how do the cellular and process imperatives come together during scale up and tech transfer and what can we learn from recent success stories? To answer this, we will look at ongoing efforts in the following areas of interest: quality by design, high throughput process development, process monitoring and control, predictive modeling and statistical process control, tech transfer, automation and facility concepts, characterization of highly complex processes, advanced in-line and at-line tools.

From Big Data to Better Cells and Processes

The acquisition, transformation and interpretation of large data sets has become a cornerstone in animal cell technology and efforts to advance digital workflows offer the potential to create better therapeutics in a shorter time in the future. In recent years, various ‘big data’ analytics and mathematical modelling tools have been developed to provide novel and deeper insights into cells and processes, which have led to an increased understanding of the biological systems used to manufacture biologics. These tools and their application have the potential to fundamentally alter modern bioprocessing methodologies. Of equal importance are both the development of digital tools as well as the transformation of these large data sets into tangible improvements in the form of better cell lines and more efficient production processes.

This scientific session will cover the latest advancements around utilizing ‘big data’ sets and emerging digital technologies including but not limited to the application of omics technologies for high content cell and process characterization, the identification of predictive biomarkers to accelerate cell line development, mechanistic & hybrid modelling, digital twins, multi-variate data analysis (MVDA), machine learning (ML) and artificial intelligence (AI) applications in bioprocessing, in order to guide, enhance and accelerate decision making and performance in all areas of biopharma including discovery and development, cell line improvement, and bioprocess advances.

HERO TECHNOLOGY SESSION - Innovate or die – technology innovation driving the understanding and control of bioprocesses

As new therapeutic modalities become more and more complex, and we move to new processes (e.g. continuous culture systems, personalised tailoring of medicines and delivery formats) novel technologies are required for process control and successful development of ideas into drugs and products. The interrogation of cell factory functional status or product status based on novel principles is likely to drive understanding and control of bioprocesses. To achieve these aspirations, the sector needs to engage with the developers of technologies that can integrate features that verify process status within and beyond the expected bioprocessing community.

This session of ESACT2024 seeks contributions on emerging technologies with the potential to enable bioprocessing breakthroughs and will consider technologies applicable to any product format and at all stages of product manufacture. The emphasis must be on technology and those that have the potential to favour step-changes in our capacity to understand and control bioprocesses will be selected for short talks on one of two sessions during ESACT2024.

ESACT 2024 BEGINS

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