From Process Knowledge to Manufacturing Confidence

10:00: Registration & Coffee
Networking over refreshments

10:30: Welcome & Introduction

10:45: Innovation Beyond Digital Twins: A Practical Framework Towards Autonomous Bioprocessing Combining Contextualised Data, Dynamic Models, and Integrated PAT Tools, Kallum Doyle, ME PhD, Research Fellow, The Medicine Accelerator

This session outlines a practical framework for turning complex bioprocess data into faster, more confident CMC decisions by connecting contextualised knowledge, dynamic models, and targeted PAT. It will show how iAchieve can help move advanced digital approaches beyond proof-of-concept toward scalable, GMP-relevant process understanding, control, and manufacturing readiness.

11:15: Risk-Based Implementation of PAT for Real-Time Drug Substance Identification in GMP Manufacturing, Ana Luiza Pinto Queiroz, The Medicine Accelerator

A structured, risk-based PAT implementation can move drug substance identification from offline testing to real-time GMP decision-making. This session will highlight the operational value for MSAT and manufacturing teams, including reduced material loss, faster cycle times, lower analytical burden, stronger process control, and sustainable lifecycle management.

11:45: From Deviation to Decision: Using iAchieve to Accelerate Manufacturing Investigations, Cormac Byrne, The Medicine Accelerator

Manufacturing investigations depend on how quickly teams can connect what happened, what changed, and what the evidence says. This session will explore how iAchieve's Activate, Live, and Answers modules can help MSAT and GMP teams connect historical process knowledge, live project context, and evidence-backed insights to support faster root-cause analysis, stronger investigation narratives, and more confident corrective actions.

12:15:  What’s Going On in There? Using CFD to Understand and Improve Mixing from Tech Transfer to Troubleshooting, Isar Charmchi, The Medicine Accelerator

Mixing, flow, and heat-transfer behaviour can be difficult to observe through experimentation alone, especially during scale-up, tech transfer, and troubleshooting. Through practical case examples, this session will demonstrate how Computational Fluid Dynamics can support process changes, scale-up/scale-down decisions, tech transfer, and manufacturing troubleshooting with greater confidence and less risk.

12:45: Advanced Therapeutics Ireland: Establishing Ireland as a leader in ATMP Manufacturing, Niall Barron, NIBRT

Advanced Therapeutics Ireland is an umbrella brand representing the Cell and Gene Therapy Forum (CGT Forum), which is dedicated to positioning Ireland as a global leader in the development, manufacture, supply and adoption of advanced therapies. This brings together a diverse and growing community of over 200 members from multinational biopharma companies and indigenous biotechs to academic researchers, clinicians, government agencies, the investor community and patient advocacy groups, all united by a shared ambition to drive this exciting sector forward. This presentation will provide an overview of the work of the Forum and how it has led to initiatives such as the TRANS-AM collaboration between APC, NIBRT and UCD.

13:00: Built for Complexity: GMP Services to Support MSAT Challenges, Niall O'Doherty, The Medicine Accelerator

As MSAT teams face increasing pressure to resolve deviations, support transfers, improve process performance, and maintain GMP readiness, targeted technical support can help close the gap between process knowledge and manufacturing execution. This session introduces The Medicine Accelerator’s consultancy model for MSAT, highlighting how GMP services, manufacturing science expertise, and applied problem-solving can support investigations, troubleshooting, process improvement, and lifecycle management.

13:10: Industry Review and Session Close

13:15: Lunch & Networking