Your Host
Former Chair BioPharmachem Ireland (BPCI);
Chief Operations Officer (COO), VLE Therapeutics Ltd
Driving High-Impact MSAT Solutions: Practical Strategies for Irish Pharmaceutical Manufacturing
Save the Date! This event will take place in Dublin in October. Sign up below to receive updates.
This workshop will explore how advanced process tools—such as Computational Fluid Dynamics (CFD), data analytics, and Process Analytical Technology (PAT)—can address key MSAT challenges, including manufacturing deviations, tech transfer, new product introductions, lifecycle management, and cost reduction. These critical issues must be navigated within the constraints of budgets, regulatory requirements, and diverse manufacturing infrastructures.
Participants will gain insights into how expert consultative MSAT support can drive measurable process improvements without the need for large-scale investments. The session will also highlight how targeted, high-impact initiatives can enhance site performance, strengthen global competitiveness, and secure the long-term standing of Irish manufacturing facilities within multinational organizations.
Attendees will leave with practical strategies for implementing cost-effective, data-driven solutions that align with both site-specific and corporate objectives.
Paul McCabe
Former Chair BioPharmachem Ireland (BPCI);
Chief Operations Officer (COO), VLE Therapeutics Ltd
Agenda
Join us for this exclusive workshop designed for senior MSAT professionals in Irish pharmaceutical manufacturing:
10:30 Registration & Coffee
11:00 Welcome
11:15 Case Studies and Presentation by Subject Matter Experts
Presentation 1: Data-Driven Excellence: Leveraging Advanced Analytics for Process Optimization
This presentation explores how advanced analytics, including multivariate data analysis, Design of Experiments (DoE), and Bayesian optimization, can drive process understanding, root cause analysis, and continuous improvement in pharmaceutical manufacturing. Through real-world case studies, attendees will learn actionable strategies for leveraging data-driven methodologies to optimize workflows, improve product quality, and enhance scalability while maintaining regulatory compliance.
Presentation 2: Unlocking Process Understanding with CFD: From Tech Transfer to Troubleshooting
This presentation highlights the role of Computational Fluid Dynamics (CFD) in optimizing pharmaceutical manufacturing processes by providing insights into fluid flow, heat transfer, and mixing dynamics. Through case studies, attendees will learn how CFD can de-risk process changes, enhance efficiency, and support technology transfer while integrating with experimental data and broader digital transformation strategies.
Presentation 3: Process Analytical Technology (PAT): The Key to Smarter Pharmaceutical Manufacturing
The pharmaceutical industry is adopting Process Analytical Technology (PAT) to enable smarter, data-driven manufacturing with real-time monitoring, advanced analytics, and automation, resulting in improved product quality and efficiency. This presentation explores how Advanced Process Control (APC) supports PAT implementation across all product lifecycle stages, from development to established commercial processes.
Presentation 4: From Lab to GMP in less than 12 Months: Pioneering the First ATMP Developed & GMP Manufactured in Ireland with Tech-Powered CMC
APC & VLE Therapeutics - The Medicine Accelerator, propelled an advanced therapeutic medicinal product (ATMP) from its process development labs to its GMP manufacturing plant in less than12 months, achieving the first ATMP developed & GMP manufactured in Ireland. A novel platform process slashed cost of goods sold from $16,000 to $1,000 per dose and boosted product yield per cell by 400%. Processing time dropped from 120 to 38 days via a deep tech stack and digital tools, while the impurity profile saw marked improvement. This robust, intensified manufacturing approach eliminated clinical and commercial bottlenecks, setting a new standard for ATMP scalability. This talk explores how tech-driven CMC accelerates process development and manufacturing timelines for complex therapeutics, and creates a paradigm shift by minimising Tech Transfer model, all here in Ireland.
12:45 Open discussion
13:15 Complementary Lunch & Networking
14:00 END
Who Should Attend
Technical Directors and Site Leads looking for practical, cost-effective strategies to address MSAT challenges, from troubleshooting deviations to supporting tech transfer.
Senior MSAT Managers in Irish pharmaceutical manufacturing (both Biologics and Small Molecule) responsible for overseeing site-level MSAT operations and improvements.
Process Development Leaders interested in learning how modeling, PAT, and other advanced tools can address site-specific operational and resource limitations.
Operations and Production Managers focused on enhancing site performance and reducing costs (COGS) while aligning with global corporate expectations.
Manufacturing Strategy Leads who aim to strengthen the Irish site’s value proposition within larger global parent organizations through targeted, high-impact projects.
Engineering and Process Support Managers interested in leveraging short-term, consultative MSAT support to complement internal resources and fill expertise gaps.
This audience will gain practical insights on implementing impactful MSAT solutions, enhancing site-level performance, and ensuring alignment with both site-specific and global corporate objectives.
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