SES

As the pharmaceutical industry advances toward the vision of Pharma 4.0, the transition from connected to predictive manufacturing environments is becoming a strategic priority. A key enabler of this transformation is Advanced Physical Layer (APL) Ethernet technology, which delivers high-speed, intrinsically safe, two-wire Ethernet communication directly to field-level devices in hazardous production environments.

This is a joint presentation between Fujifilm Diosynth Biotechnologies and PM Group about a next generation aseptic robotic filling platform. The technology called AZZURRA has taken over 5 years to develop by a collaboration of different companies with the aim of overcoming the limitations and project delivery issues associated with existing filling technologies including the latest gloveless isolator offerings. Azzurra is part of the FDA Emerging Technology Programme and the EMA's Quality Innovation Group.

Digital transformation goes far beyond implementing new technologies or upgrading manufacturing systems. It is a holistic, enterprise-wide shift that demands unified governance, cross-functional teams, and clear strategic drivers. Success is not just measured in operational gains but in the ability to unlock new business models and embrace fundamentally different ways of working. True transformation means reshaping the organization at every level — from the factory floor to the executive suite.

The continuous manufacturing process of Active Pharmaceutical Ingredients (APIs) in Pfizer is based on the Flexible API Supply Technology (FAST) concept. FAST is a novel facility design approach in which modular equipment can be installed in multiple different configurations dependent upon the manufacturing process requirements. It will utilize various types of modularized equipment to allow for “plug and play” unit operations. Process Analytical Technology (PAT) is integrated in the FAST platform.

In September 2024, Hurricane Helene made landfall with devastating force in North Carolina, severely impacting the Baxter North Cove manufacturing facility.

2025 ISPE Facility of the Year Awards (FOYA) Category Winners Showcase: 20 Years of Innovation in Facility Excellence

Celebrate 20 years of FOYA with us in this milestone session that honors the past, present, and future of pharmaceutical facility innovation.

Led by Dave DiProspero, this engaging, roundtable-style discussion will feature some of the 2025 FOYA Category Winners and a panel of seasoned FOYA judges.

The ISPE Membership Meeting and Awards Lunch is open to all education attendees, including those with an In-Person All Access Pass and the Tuesday One-Day Education Pass.

Meet and hear from the ISPE leadership and colleagues while learning about significant achievements made by the industry in the past year. Celebrate with your peers as the ISPE International Honor Awards are presented and learn about the 2025 Facility of the Year Awards (FOYA) Category Winners & Overall Winner.

Students and recent graduates will be tasked with analyzing a problem statement, acting as a consultant group to help the company solve an issue, to pitch it to a panel of expert judges at the culmination of the Hackathon. At the end of the two days, each team will present a group of judges and industry leaders. The judges will evaluate the presentations, provide feedback to the teams, and identify the best solution.

In the rapidly evolving bioanalytical testing landscape, the need for high-throughput and reliable serological assays has underscored significant challenges in data management and regulatory compliance. The amount of data generated by an automated platform presents unique challenges in the regulated environment, as it is key to ensure that samples can be accurately and rapidly traced throughout the workstream.