Day One - Tuesday 3rd December, 2024 - GMT (Greenwich Mean Time, GMTZ)
Day One - Tuesday 3rd December, 2024 - GMT (Greenwich Mean Time, GMTZ)
Ireland's thriving biomanufacturing sector benefits from tax incentives, skilled talent, and a supportive regulatory climate. Navigating Annex 1, nitrosamine, and glycol regulations is crucial. Key players and talent development are essential for cost-effective biopharma production. Strategic planning and robust infrastructure are vital to Ireland's continued success in this competitive market.
- 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
- Liz Dooley - Senior Director, Global Engineering & Technology, Johnson & Johnson, ISPE Global Board of Directors, Ireland
- A Representative - of, IBEC, Ireland
- Tiffany Rau - Adjunct Professor Biochemistry and Cell Biology, University College Cork, Ireland
Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us to identify custom solutions to help you reach your goals.
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The project demonstrates the application of the Design for Lean Six Sigma and structured Define, Measure, Analyse, Design, and Verify methodology in designing and implementing a process that enables the case study manufacturing site to improve its space utilisation and free up space.
- Olivia McDermott - Associate Professor in Regulatory Affairs & Lean Quality Management, University of Galway, Ireland
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.
- Sharon Fitzgerald - Senior Manager, Manufacturing Technology, Bristol-Myers Squibb, Ireland
Understand the concept, integrate new technologies, and address workforce gaps to drive successful innovation initiatives.
- Martin Hurley - Managing Director, BioPharma Technical Consulting (BPTC), Ireland
A session dedicated to feedback from Eli Lilly on their manufacturing operations Ireland. Providing practical feedback and bench marketing opportunities, engineering considerations and strategies for commercial manufacturing.
- Matthew Osborne - Associate Vice President Network Technical Services/Manufacturing Sciences, Eli Lilly, Ireland
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.
- Harris Makatsoris - Academics Professor of Sustainable Manufacturing Systems, King's College London
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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.
- Ciera Clayton - Global Change Facilitator (MES of the Future, BPIT & Risk and Business Continuity Management, SR), BioPhorum, United Kingdom
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.
- Sarah Hudson - Co-Principal Investigator & Materials Theme Leader, University of Limerick, SSPC (The Science Foundation Ireland Research Centre for Pharmaceuticals), Ireland