Day One - Tuesday 3rd December, 2024Tuesday, 3 December 2024 - GMT (Greenwich Mean Time, GMTZ)

• How are associations and government agencies partnering and working together with biopharm companies to drive manufacturing in Ireland?
• What is the role Academic Institutions play?
• Funding initiatives
• Government policies in place
  
  

Optimize processes from discovery to commercialization by involving manufacturing early. Eliminate tech transfer bottlenecks. Seamlessly introduce new products and processes. Achieve economies of scale through process optimization.

Understand the concept, integrate new technologies, and address workforce gaps to drive successful innovation initiatives.

Eli Lilly has had an almost twenty-year journey of biomanufacturing operations in Ireland. From an announcement in 2006 initiating biologics manufacturing in Ireland, Lilly now operates 3 Biologics facilities making globally approved medicines. This is believed to provide the largest biomanufacturing footprint in Ireland. With construction nearly complete on a further facility and a recent announcement of a further expansion, Lilly will ultimately operate 5 biomanufacturing facilities in Ireland. Over this time the platform process has also improved seven-fold in terms of output titre.

The presentation will discuss this phenomenal expansion of operations and productivity and will discuss how this succus was built on a number of factors including:

• Building technical capability and strong partnerships
• On-time delivery of each facility and operational excellence in execution of every batch
• Lockstep collaboration with R&D to evolve the manufacturing platform

The talk will also discuss the future expansions and what Lilly terms “Next Generation Biologics” for a further step change in production efficiency

Professor Harris Makatsoris from King’s College London on developing a ‘factory-in-a-box’ that allows the rapid manufacture of synthetic RNA vaccines and minimises the space required for high-volume vaccine production.

In the current biopharmaceutical manufacturing landscape, efficient orchestration of end-to-end production processes is critical for success. Manufacturing execution systems (MES) have evolved from basic data collection tools into sophisticated systems that drive operational excellence. However, their full potential is only unlocked when integrated seamlessly with other software solutions.

This paper outlines the significance of MES integration with systems such as enterprise resource planning, quality management systems, and laboratory information management systems. A lack of standardized processes in the industry has led to complexity, hindering implementation and scalability. These integration challenges result in manual data entry, increased deviations, longer release times, and higher costs.

Specific integrations highlighted in this paper can streamline operations, enhance efficiency, reduce costs, and offer real-time visibility across departments and business units. The clear guidelines and recommendations for integrating MES provide a shared understanding of the value proposition and offer insights into the ‘why’ and ‘what’ of MES integration for manufacturers and vendors.

Understanding the synergy between MES and other (bio)pharmaceutical manufacturing systems can empower companies to plan strategically, optimize production processes, and advance toward higher digital plant maturity. Used during implementation, our paper will help you consider factors such as quality impact, automated interfaces, business continuity, security, and data governance for successful deployment.

MES integration is critical for enhancing biopharmaceutical manufacturing operations and achieving digital maturity. By following the guidelines and recommendations, this paper facilitates alignment between companies and vendors, enabling them to realize the benefits of a comprehensive and efficient manufacturing ecosystem.

A regional case study discussing some of SSPC's work with biopharmaceuticals. With insight on protein production, cell & gene therapies & drug hybrid conjugates.

SSPC provides the life sciences sector with a nationally distributed, research performing community that enables high impact, collaborative research between industry and academic partners.

SSPC is funded by Science Foundation Ireland and proudly hosted by the University of Limerick working with eight higher-education institutes (HEIs) including Trinity College Dublin, University College Dublin, Dublin City University, University College Cork, University of Galway, Maynooth University, RCSI University of Medicine of Health Sciences and SETU Waterford.