Agenda

0730 – 0830

Welcome to the 2025 ISPE Biotechnology Conference

General Session

Mike Martin, ISPE

0840 – 0850

A Word from the ISPE Foundation

General Session

James Grunwald, Arcadis

0850 – 0920

AI as an Enabler for a Sustainable Quality Transformation

General Session

Magaly Aham, Takeda - Boston

0920 – 0950

Data Management Requirements for Sterile Manufacturing Processes

General Session

Ronald Bauer, PhD, Austrian Agency for Health and Food Safety (AGES)

0950 – 1020

Thriving in Expansion: Compliance & Improvement Blueprint

General Session

Eamonn Warren, Eli Lilly and Company

1020 – 1030

Message from the Conference Chair

General Session

Michelangelo Canzoneri, Merck KGaA Darmstadt, Germany

1030 – 1115

Networking Break in the Expo Hall

1030 – 1900

Critical Utilities Sustainability - Case Study

Process Intensification Continuous Manuf. and Sustainability

Dino Valente, Stilmas Americas

1115 – 1145

Cognitive Laboratory: Leveraging AI to Decode Biopharma

Accelerating Biopharma with AI & ML

Srividya Narayanan, Northeastern University

1145 – 1215

Process Mass Intensity for Sustainable Biotech Decisions

Process Intensification Continuous Manuf. and Sustainability

Neil Gamble, PE, Arcadis

1145 – 1215

Enabling AI & ML with a Data Centric Architecture

Accelerating Biopharma with AI & ML

Matthias Kress, BioGrasp GmbH

James Sunna, Theos-CES GmbH

1215 – 1245

From Reactive to Proactive: Leveraging AI/ML to Improve the Quality Unit

Accelerating Biopharma with AI & ML

Michael De La Torre, Redica Systems

1215 – 1245

Integrated Buffer Blending in Continuous Chromatography

Process Intensification Continuous Manuf. and Sustainability

Vinit Saxena, Sepragen Corporation

Sanjeev Saxena, Sepragen Corporation

Process intensification through the integration of batch or continuous chromatography with inline buffer blending offers significant advantages for biopharmaceutical manufacturing. This approach streamlines workflows by combining high-throughput purification with on-demand buffer preparation, reducing equipment footprints, buffer storage needs, and operational complexity. Inline blending enables precise, real-time buffer preparation, minimizing variability and improving process control. Continuous chromatography ensures consistent product quality and increased productivity by operating at steady-state conditions. Together, these technologies enhance scalability, lower costs, and support flexible manufacturing, making them ideal for modern bioprocessing and meeting the demands of dynamic therapeutic production. We will share what such a novel process design does for Improved Facility layout and reduction of Capital cost in addition to simplified workflow and reduced cycle time, reduced FTEs and COGs. Data will be presented from case studies showing the impact of such process design on critical process parameters and quality attributes. The take-away will be that there are simple tools and process choices available today for process intensification in bioprocess design to simplify workflow, improve facility utilization and sustainability and reduce capital and operating cost.

Vinit Saxena

Founder and CEO/ CTO
Sepragen Corporation

Sanjeev Saxena

CCO
Sepragen Corporation

1245 – 1400

Networking Lunch in the Expo Hall

1400 – 1430

How AI Enables True CPV for Real-Time Release

Accelerating Biopharma with AI & ML

Christian Gay, Aizon

1400 – 1430

Bioreactor Scale-Up and Cell Culture Intensification

Process Intensification Continuous Manuf. and Sustainability

Riju Saini, CRB

Keisuke Shibuya, PhD, Hitachi, Ltd.

1430 – 1500

Cross-Program mRNA Process Models with Interpretable Machine Learning

Accelerating Biopharma with AI & ML

Gang Wang, PhD, Moderna

1430 – 1500

Future of Process Intensification in Large-Scale Biotech

Process Intensification Continuous Manuf. and Sustainability

John Rubero, CRB

1500 – 1530

Autonomous AI – Building AI for Control and Advisory

Accelerating Biopharma with AI & ML

Chris Conry, RoviSys

1500 – 1530

We Need to Rethink Water!

Process Intensification Continuous Manuf. and Sustainability

Stephen Judd, CEng, FICHemE, FIEI, Arcadis

1530 – 1615

Networking Break in the Expo Hall

1615 – 1730

Never Have I Ever, Presented by ISPE Women in Pharma®

General Session

William Lichtman, Takeda Lexington MA

Stephanie Grant, DPR Construction

Dorrian Fragola, C&W Services

Antonia Stone, Takeda Pharmaceuticals Inc.

Eni Adedokun, Takeda

Kristina Pumphrey, Precis Engineering + Architecture

Lindsey Daniel, Takeda

Caren Jenkins, Withum

Michelle Batz, Merck & Co Inc

1730 – 1900

Welcome Reception in the Expo Hall

0730 – 1730

Registration Open

0730 – 0830

Continental Breakfast

0830 – 0900

Automation & Digital Transformation in Process Analytics

Implementing Digital Initiatives in the Biopharma Industry

Dhanuka Wasalathanthri, PhD, Bristol Myers Squibb

0830 – 0900

Future-Proofing Biomanufacturing with Capacity Modeling

Biomanufacturing Facility Lifecycle

Minhazuddin Mohammed, Takeda

0900 – 0930

Moving Beyond AI Pilots in Biopharma: Case Discussion

Implementing Digital Initiatives in the Biopharma Industry

Soumyopriyo Saha, TCG Digital Solutions LLC

0900 – 0930

From Concept to Operation: Trends and Challenges in Biomanufacturing Facility Lifecycle Panel

Biomanufacturing Facility Lifecycle

Jacob Greenwood, Project Farma

Sue Marrichi, Ultragenyx Pharmaceutical Inc

0930 – 1000

ISO14664/16 Application to Reduce Energy Demand in HVAC

Biomanufacturing Facility Lifecycle

Angelo Bernardis, MD, Wood Plc

Barbara Bagatta, Wood

0930 – 1000

Elevating Digital Data Governance in Biopharma

Implementing Digital Initiatives in the Biopharma Industry

Christian Monchinski, InflexionPoint LLC

1000 – 1345

Expo Hall Open

1000 – 1045

Networking Break in the Expo Hall

1045 – 1145

Process Architecture Panel: Innovations & Challenges in Accelerating Biopharmaceutical Manufacturing Facility Design

Biomanufacturing Facility Lifecycle

Daryl Kern, PM Group

Grace Linton, CRB

Nevine Williams, IPS

Felix Diaz, RA, NCARB, Barry-Wehmiller Design Group

Geoffrey Middleton, CGMA, Incorporated

1045 – 1115

Implementing Lifecyle Management Systems (LCM) Strategy

Implementing Digital Initiatives in the Biopharma Industry

Jennifer Tonning, Takeda

Sarbajita Ray, Takeda

1115 – 1145

Digital Transformation QC Labs: Progress & Possibilities

Implementing Digital Initiatives in the Biopharma Industry

Clarence Friedman, Waters Corporation

1145 – 1215

Accelerating Biomanufacturing Modular Design & AI Impact

Biomanufacturing Facility Lifecycle

Christian Lavarreda, Syntegon

1145 – 1215

Capturing Benchtop Manufacturing Data with PI Historian

Implementing Digital Initiatives in the Biopharma Industry

Mike LeBlanc, Trinity Life Sciences – Aztec Consulting

Jim Elliott, Trinity Life Sciences - ADVENT Engineering

Traditional methods of capturing and utilizing data from benchtop manufacturing systems involve paper strip printouts, manual data entry, manual/physical data storage, and uncontrolled spreadsheets, leading to potential errors, inconsistencies, and difficulties in data retrieval and analysis. This presentation explores how leveraging a site PI Historian can significantly improve data integrity and enable enhanced data analytics for manufacturing operations. By integrating benchtop systems with a PI Historian, real-time and historical batch data can be automatically collected, stored, and accessed in a secure and auditable manner. This eliminates paper printouts, manual data entry, reduces the risk of human error, and ensures data accuracy, traceability, and compliance.

The presentation will discuss:
• Enhance Data Integrity: Eliminate manual data entry, ensure data accuracy and traceability, and meet regulatory requirements for data integrity.
• Improve Data Quality: Collect high-quality data without data loss and ensure data consistency across different batches, operations, and systems.
• Increase Data Visibility and Enable Advanced Analytics: Utilize historical data for trend analysis, root cause analysis, alarm analysis, process optimization, and predictive maintenance.
• Increase Efficiency: Streamline data management processes, reduce manual effort, and improve overall operational efficiency.

Mike LeBlanc

Senior Automation Engineer
Trinity Life Sciences – Aztec Consulting

Jim Elliott

Computer Systems Validation Director
Trinity Life Sciences - ADVENT Engineering

1215 – 1345

Networking Lunch in the Expo Hall

1345 – 1415

Global Readiness and Program Excellence in PPQ

Operational Readiness and Cultural Excellence

Varun Choudhary, Moderna

1345 – 1415

Lean Analytical Panels to Aid Cleaning Validation

Analytical Enhanced Quality

Brian Bosso, STERIS

John Schallom, Steris

Routine cleaning validation programs rely heavily on quality control labs to analyze samples and report results in minimal time, leading to resource constraints and delayed product or equipment release. Biopharmaceutical manufacturing cleaning validation programs utilize specialized assays, instruments and reagents to demonstrate the presence, degradation or activity of residual product on cleaned equipment. A lean analytical panel at each stage of the cleaning validation lifecycle can build upon previous stages, minimizing risk of surface contamination and optimizing lab resources. Continuous, in-line monitoring, such as conductivity, TOC and UV, in addition to a robust visual inspection program, shift the testing from the lab but some technologies can be prone to false positives. Other spectroscopy methods such as FTIR, RAMAN, and fluorescence can be used to assist in residue identification and development of preventive maintenance procedures. These techniques require a balance of quality and compliance with manufacturing throughput. The strategy is supported through carefully planned studies that enhance the understanding of the manufacturing, cleaning and analytical process. This presentation will include applied laboratory models as well as case studies to better understand and incorporate a lean analytical panel and spectroscopic analytical methods to your cleaning validation program.

Brian Bosso

Technical Service Manager
STERIS

John Schallom

Senior Technical Services Associate
Steris

1415 – 1445

Cultural Excellence: What Are Companies Doing to Build a Culture That Drives Innovation and Development for the Future?

Operational Readiness and Cultural Excellence

Justin Cook, Sequence Inc

Jared Auclair, PhD, Northeastern University

Adam Sokolnicki, Millipore Sigma

In an era of rapid technological advancement and evolving regulatory landscapes, operational readiness is more than just having the right systems in place—it requires a strong culture that fosters innovation, adaptability, and continuous learning. How are leading organizations in the biotechnology industry cultivating environments that empower their teams to embrace change, drive innovation, and sustain long-term success?

This dynamic panel will bring together senior leaders from key sectors—biotechnology operating companies, engineering service providers, contract manufacturers, and university pilot facilities—to engage in a candid discussion about cultural excellence as a foundation for operational readiness. Panelists will share insights on:

- Building a high-performance culture that encourages innovation and agility in an evolving industry.
- Overcoming resistance to change by fostering a mindset of adaptability and continuous learning.
- Developing workforce capabilities to keep pace with cutting-edge technologies and new operational models.
- Bridging the gap between technical excellence and cultural transformation to drive long-term success.

Join us for an engaging conversation with industry experts who are shaping the future of biotechnology operations by prioritizing people, culture, and innovation.