Overcoming Bottlenecks in PAT Deployment: Bridging the Gap Between Lab & Manufacturing

The value of PAT is underscored through its ability to enable real-time monitoring, enhance process understanding, improve product quality, and accelerate development and tech transfer.  However, successful deployment requires improvements in industrial systems and data infrastructure to support scalable, reliable use of PAT at manufacturing sites. This includes strengthening data integration, ensuring robust data pipelines, and enabling seamless transition of lab-developed PAT solutions to shopfloor execution environments. The presentation will address the critical need to develop scalable systems that simplify the integration of Process Analytical Technologies (PAT) into routine manufacturing while ensuring data integrity and regulatory compliance. It will emphasize that successful PAT deployment in a GMP environment requires a truly multidisciplinary approach, bringing together R&D CMC, MSAT, Quality Control, Quality, Regulatory, Operations, Engineering, Maintenance and Data Science functions. The talk will start on how to ensure a successful PAT continuum from R&D CMC toward Commercial Products and will deep dive on the adoption of standardized architectures, the implementation of robust PAT data and model management platforms, and the establishment of validated workflows aligned with GMP requirements. It will highlight practical strategies to enable sustainable PAT adoption and accelerate digital transformation in biopharmaceutical manufacturing.

Presented by Luc Nguyen, Global Head of Process Analytical Technologies (PAT) within MSAT at Sanofi

Luc Nguyen is the Global Head of Process Analytical Technologies (PAT) within MSAT at Sanofi where he leads the global deployment of PAT strategies to enable real-time release, continuous manufacturing across all drug modalities. He is also an active member of the BioPhorum Technology Strategy Workstreams contributing to the advancement of PAT and Digital Twin adoption in GMP environments, and is passionate about leveraging data and innovation to transform biopharmaceutical manufacturing. With over 25 years in senior leadership roles across global pharmaceutical organizations in manufacturing, R&D, QC labs and quality functions, he is passionate about leveraging data and innovative technologies to transform biopharmaceutical manufacturing and deliver high-quality medicines worldwide.

Ramila Peiris, Global Head of Process Data Management, Machine Learning, and AI Platform MSAT at Sanofi

Ramila Peiris is the Global Head of Process Data Management, Machine Learning, and AI Platform within MSAT at Sanofi, where he defines the strategy and vision for data engineering, and AI solutions across manufacturing operations. With over 15 years of experience, Ramila has championed the adoption of advanced technologies – including Generative AI, Process Analytical Technology (PAT), and prescriptive analytics – successfully scaling initiatives from proof-of-concept to enterprise deployment. Ramila is recognized for bridging technical innovation with operational execution, enabling data-driven decision-making, and improving process performance in GxP-regulated environments. He is a strong advocate for building data- and AI-driven cultures by aligning cross-functional teams around trust, governance, and value realization.

Followed by Michael Sachpekidis, Global Account Director at SciY

Michael Sachpekidis has an automation background, and extensive experience in software, automation, and measurement systems. At SciY, Michael helps customers improve product quality, costs, and time to market, with synTQ PAT knowledge management software and the SciY Digitalization Suite.

Maryann Cuellar, Life Science Industry Manager at Endress+Hauser Optical Analysis

Maryann Cuellar is the Life Science Industry Manager at Endress+Hauser Optical Analysis, where she leads the strategic direction for Raman spectroscopy solutions in the life sciences sector. With over 20 years of experience supporting implementation of process analytical technology (PAT), she has been instrumental in translating laboratory innovation into scalable, GMP-ready products and services. Throughout her career, Maryann has led the development and launch of novel Raman applications and integrations, often working closely with academic and industry partners. She is widely recognized for advancing the adoption of Raman in biopharma and helping define best practices for model development and deployment. She is an active contributor to BioPhorum, collaborating to advance practical approaches for PAT implementation. Maryann holds a master’s degree in analytical chemistry, with a research specialization in chemometrics.

Followed by a live question and answer session

Sponsored by SciY and Endress+Hauser

About SciY

Designed to support your digitalization journey, the SciY Digitalization Suite integrates best-in-class technologies and capabilities originally developed by Mestrelab, Optimal, ZONTAL, Arxspan and LOGS, harmonized within the Bruker ecosystem. The vendor-agnostic platform supports life sciences research, development, manufacturing automation and QC functions – with easy-to-integrate, flexible, and user-centric solutions.

For more information, visit www.sciy.com      

About Endress+Hauser

Endress+Hauser, a global leader in measurement and automation technologies for process and laboratory applications, is a family-owned company with a broad portfolio of services, solutions and instrumentation. Endress+Hauser serves customers in the chemical, food and beverage, life sciences, power and energy, oil and gas and water and wastewater industries. The company’s products provide valuable data and insights into processes, support process optimization, efficiency and safety for people and the environment. Today, Endress+Hauser has more than 9,400 patents and patent applications.