PAT Evolution and Implementation: Navigating Regulatory Guidelines, and Best Practices for Tool Selection and Validation

Process Analytical Technology (PAT) has evolved significantly since the FDA’s 2004 PAT Guidance, transitioning from a conceptual framework into a cornerstone of modern pharmaceutical manufacturing. Today, a robust and converging regulatory landscape, spanning the U.S. Food and Drug Administration (FDA), International Council for Harmonisation (ICH), United States Pharmacopeia (USP), European Pharmacopoeia, and ASTM International, strongly supports PAT adoption as a key driver of quality, efficiency, and innovation.

Despite this progress, implementation across the industry remains inconsistent, highlighting a persistent gap between regulatory vision and operational reality. The complexity of navigating multiple regulatory frameworks and integrating advanced analytical tools into manufacturing environments presents significant practical challenges.

This presentation provides a roadmap to bridge these gaps by aligning regulatory expectations with practical implementation strategies. It focuses on best practices for PAT tool selection and validation, offering actionable insights to support compliance while enhancing product quality, manufacturing efficiency, and driving innovation in pharmaceutical manufacturing.

Presented by Dr. Farshid Mohammadparast, Process Analytical Technology (PAT) and Chemometrics Principal Investigator at USP

Dr. Farshid Mohammadparast is a Process Analytical Technology (PAT) and Chemometrics Principal Investigator at USP, with a Ph.D. in Chemical Engineering and over nine years of research and industry experience. He leads initiatives and projects focused on PAT and emerging advanced analytical technologies, aiming to enhance pharmaceutical manufacturing efficiency, product quality, and supply chain resilience. He has authored peer-reviewed publications and a book chapter in the fields of chemistry and advanced materials. His expertise spans spectroscopy, imaging techniques, chemometric, AI/Machine learning, and the characterization of both organic and inorganic compounds.

Why Enterprise PAT Adoption Is Challenging – and How to Build a Program That Scales

As pharmaceutical pipelines shift toward increasingly complex modalities — biologics, cell and gene therapies, and advanced delivery systems — Process Analytical Technology (PAT) is emerging as a foundational, not optional, capability for ensuring quality. This talk traces PAT’s role across the full CMC lifecycle, from development and optimization through monitoring and control, and examines how realtime measurement connects to the quality metrics that define complex drug design, formulation, and manufacturing. We review PAT technologies spanning small molecules to large-molecule biologics, current regulatory expectations (ICH guidelines, FDA guidance), and the distinct adoption challenges organizations face at each stage — from early development through post-approval. Drawing on an investment-versus-benefit framework, I outline practical strategies for sequencing enterprise-wide deployment, the governance structures that sustain programs beyond a pilot level single initiative, and how PAT possibly integrates into a broader digital control-strategy architecture.

Presented by Atanu Sengupta, Lead – New Technologies & External Collaborations at Dr. Reddy’s Laboratories

Dr. Atanu Sengupta is Lead – New Technologies & External Collaborations at Dr. Reddy’s Laboratories, with extensive experience in Process Analytical Technology (PAT), advanced analytical technologies, biosensors, continuous manufacturing, process modeling, and digital transformation. Previously with Merck and Enquyst Technologies in the United States, he contributed to PAT and advanced manufacturing initiatives, including applications in vaccines and continuous processes. His work focuses on integrating advanced spectroscopy, sensing and biosensor technologies, real-time process monitoring, digital twins, and data-driven approaches to enhance process understanding, manufacturing efficiency, quality, and operational excellence.

From Process to Product: Implementing Raman-Based PAT in Pharmaceutical Manufacturing

Process Analytical Technology (PAT) is transforming pharmaceutical and biopharmaceutical manufacturing by enabling greater process understanding, real-time control, and more efficient quality assurance. Successfully implementing PAT, however, requires both robust analytical technologies and a structured approach to validation, regulatory compliance, and lifecycle management.

This webinar explores how complementary Raman spectroscopy solutions can support PAT strategies from in-line process monitoring through final-product testing. Attendees will learn how in-line Raman enables real-time, non-destructive monitoring of critical process parameters, while benchtop Raman extends analytical capabilities to final-product verification through sealed vials during fill-finish. The session will also examine practical considerations for deploying Raman in regulated manufacturing environments, including system qualification, software controls, data integrity, chemometric model development, validation, and lifecycle management.

A key focus will be on chemometric model transferability across instruments, sites, and workflows to reduce model redevelopment, improve consistency, and strengthen continuity from process development through commercial manufacturing. Using real-world implementation examples, the speakers will discuss best practices for selecting, validating, and maintaining PAT solutions that support cGMP requirements and 21 CFR Part 11–aligned workflows. Attendees will leave with a practical, risk-based framework for implementing Raman-based PAT to accelerate decision-making, improve process understanding, and support consistent product quality.

Presented by Parag Borgaonkar, MBA, Sr. Business Development Specialist at Thermo Fisher Scientific

Parag Borgaonkar is a business development leader at Thermo Fisher Scientific with deep expertise in Process Analytical Technology (PAT) for pharmaceutical and biopharmaceutical manufacturing. His work focuses on advancing Raman and near-infrared (NIR) spectroscopy, chemometrics, and real-time analytical workflows that support faster, more reliable process monitoring and quality decision-making. He specializes in helping translate advanced analytical technologies into regulatory-ready, scalable solutions for GMP-regulated manufacturing environments. Through his leadership, he supports modernization of pharmaceutical quality systems, improved manufacturing efficiency, and stronger supply chain resilience. 

Sudhir Dahal, PhD., Product Marketing Manager for Research Raman Products at Thermo Fisher Scientific

Sudhir Dahal, PhD is a Product Marketing Manager for Vibrational Spectroscopy Product Portfolio (FTIR, Raman, NIR) at Thermo Fisher Scientific, where he focuses on bringing advanced spectroscopy solutions to market for demanding pharmaceutical and industrial applications. With over a decade of experience in analytical instrumentation, Sudhir works closely with customers, application teams and R&D to translate real-world QC challenges – such as biopharma fill-finish testing, data robustness and scalability – into practical, automation-ready solutions.  He holds a Ph.D. from the University of Maryland, Baltimore County, where he developed spectroscopy-based methods for biomedical analysis. Sudhir is passionate about connecting technology, workflow, and market needs to enable smarter, data-driven quality control.

Followed by a live question and answer session

Sponsored by SciY and Thermo Fisher Scientific

About SciY

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 Thermo Fisher Scientific

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue over $45 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Gibco, Fisher Scientific, Unity Lab Services, Patheon and PPD.