The International Society for Pharmaceutical Engineering - ISPE

01/23/2026

Advancements in technology, such as process intensification, continuous manufacturing, and 3D printing, are enabling manufacturing models such as distributed, point-of-care, and transportable manufacturing. While these platforms are redefining what’s possible, they also raise critical questions about regulation, quality, and global harmonization. A session at the 2025 ISPE Annual Meeting & Expo explored the technologies, best practices, challenges, and regulatory thinking that impact the realization of these manufacturing platforms.

Read more in this iSpeak blog:

Pharmaceutical manufacturing is at a turning point. For decades, large-scale centralized facilities have been the backbone of medicine production, but today’s healthcare landscape demands something different: flexibility and personalization. Patients need therapies that are accessible anywhere, ta...

01/22/2026

Are you—or someone you know—a student or recent graduate looking to grow a career in the life sciences industry? The ISPE Foundation is accepting applications for the Jack Lysfjord Grant, which supports attendance at the 2026 ISPE Aseptic Conference.

This grant is open exclusively to students and recent graduates and is designed to help reduce financial barriers to participating in one of ISPE’s key technical conferences. Grant recipients will have the opportunity to engage with industry leaders, gain exposure to current aseptic practices and technologies, and begin building a professional network early in their careers.

The application deadline is Friday, 27 February. Apply now: https://hubs.ly/Q03_Nspp0

01/22/2026

Discover the future of sterile manufacturing at the 2026 ISPE Aseptic Conference. Taking place 23–24 March in Washington D.C., USA this event is set to be the year's most influential gathering for pharmaceutical, biotech, and advanced therapy professionals. Building upon the success of last year, the international program committee has curated a dynamic agenda led by the experts shaping the industry today.

Why Attend?
• World-Class Insights: Learn from global speakers at the forefront of aseptic processing
• Comprehensive Content: Access the latest innovations, regulatory updates, and best practices
• Unparalleled Networking: Connect with peers in the most comprehensive forum of its kind

Read more in this iSpeak blog by Keith Weseli: https://hubs.la/Q03_0R_r0

01/21/2026

As the pharmaceutical landscape evolves rapidly with the integration of AI, smart manufacturing, and ATMPs, a conference must deliver meaningful value that captures the industry's current pulse.

David Estape, Chair of the 2026 ISPE Europe Annual Conference, shares key insights on what attendees can expect. This is the perfect opportunity to benchmark strategies against the industry’s best and tackle critical challenges like drug shortages and global access.

Read more in this iSpeak blog: https://hubs.la/Q03_BRtR0

01/21/2026

Intended to bridge near‑term operational realities with longer‑term investments in robust sterile and contamination-controlled operations, this white paper from the Global Pharmaceutical Manufacturing Leadership Forum (GPMLF) outlines how manufacturers can prioritize control and monitoring of critical activities while adopting facility and equipment strategies aligned with current expectations. It also reinforces the essential role of qualified personnel, proper gowning, and disciplined behaviors in maintaining controlled environments and preventing contamination.

Read the full white paper by the GPMLF: https://hubs.la/Q03-Sz-p0

01/20/2026

ISPE has reached a historic double milestone: 25,000 members and a LinkedIn community of over 100,000 followers. While we are proud of the numbers, we are even prouder of what they represent: a massive, thriving global network of life science professionals passionate about innovation.

This growth would be impossible without the dedication of our community. To celebrate this momentum, we want to hear from you.
• For Current Members: Share your unique ISPE story or memory
• For Future Members: Tell us why you aspire to join the ISPE community

Share your story now for a chance to win a complimentary one-year membership: https://hubs.la/Q03_BTQM0

01/20/2026

ISPE Pharma 4.0™ Community of Practice (CoP) members Michelangelo Canzoneri, Hans Heesakkers, Teresa Minero, Christian Wölbeling, and Thomas Zimmer explore the impact of Pharma 4.0™ on digitalization, operational excellence, and business strategy within the pharmaceutical industry.

Part one of the three-part series begins with building a business case for Pharma 4.0. The CoP members discuss how to tailor narratives to key stakeholders, develop key performance indicators to manage outcomes, and more.

Read article: https://hubs.la/Q03_nMvL0

01/19/2026

Mike Martin, President and CEO of ISPE, recently sat down with Nicholas Kapman, President and CEO of The FDA Group, for a discussion about the complexities facing the life sciences industry today.

They didn't just discuss the challenges; they explored actionable, innovative strategies to overcome them. If you are looking to stay ahead of the curve in compliance and operations, this is a must-listen. https://hubs.la/Q03_nkCm0

The 2026 ISPE Facilities of the Future Conference will host sessions on preparing the future workforce, including “Enhancing Student Readiness for the Pharmaceutical Workforce” and “Transforming Talent: Results of Strategic Partnerships.” Explore the agenda: https://hubs.la/Q03_nkxH0

01/19/2026

Congratulations to the ISPE Product Quality Lifecycle Implementation (PQLI)® Committee’s Q12 and Q13 Teams for receiving the Committee of the Year Award, as part of the 2025 ISPE International Honor Awards.

Recognized during the ISPE Membership Meeting and Awards Lunch at the 2025 ISPE Annual Meeting & Expo in October 2025, this award honors ISPE members and contributors whose dedication and service exemplify what it means to Shape the Future of Pharma™

Since 2022, the ISPE PQLI® Committee Q12 and Q13 team members have successfully organized and delivered five impactful training sessions on ICH guidelines to health authorities across multiple continents. This included the delivery of training on ICH Q12 implementation to four unique agencies: Health Canada and Brazil’s ANVISA in 2022, the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) in 2023, and Singapore’s Health Sciences Authority (HSA) in 2024, with participation from the US Food and Drug Administration (US FDA) in the most recent two events. In 2025, the teams delivered training on ICH Q13 to Health Canada with participation from MHRA and HSA. Due to these efforts, more than 480 inspectors and reviewers have been trained by the two PQLI working groups globally.

Read iSpeak article: https://hubs.ly/Q03-Yjdy0

01/17/2026

Advanced therapy medicinal products (ATMPs) are redefining the boundaries of modern medicine. These cutting-edge treatments offer unprecedented opportunities to address complex diseases and deliver life-changing outcomes for patients. Yet, as this field rapidly evolves, so do the challenges—ranging from regulatory frameworks to manufacturing agility. To stay ahead, the industry must embrace innovation, collaboration, and resilience. The 2026 ISPE Aseptic Conference provides the perfect platform to explore these critical themes, bringing together experts to share insights and chart the path forward for ATMP manufacturing.

Read more in this iSpeak blog by Erich Bozenhardt and Nidhi Shah: https://hubs.la/Q03-ZTys0

Learn more and register for the 2026 ISPE Aseptic Conference: https://hubs.la/Q03-ZWgq0

01/16/2026

Your insights are the catalyst to advancing industry improvements, shaping regulatory understanding, and unlocking the transformative potential of Pharma 4.0™

Help drive progress and take the brief 2026 ISPE Pharma™ Survey. Submit your responses by 31 March to help us expand our findings: https://hubs.la/Q03-ZbgG0

Then, join us to see the results revealed live during the 2026 ISPE Europe Annual Conference held 20-22 April in Copenhagen, Denmark. Register now: https://hubs.la/Q03-Z6JJ0

01/15/2026

ISPE’s 2025 Global Regulatory Town Hall focused on the future of pharmaceutical regulation with a focus on digital transformation and how Pharma 4.0™ is revolutionizing drug manufacturing development through the integration of AI. The Town Hall, held on the final day of the 2025 ISPE Annual Meeting & Expo, featured an interactive industry-regulator panel that addressed compliance challenges and evolving regulatory expectations, as well as real-world industry applications and innovations driven by AI

Read more in this iSpeak blog:

On the final day of the 2025 ISPE Annual Meeting & Expo, regulators and senior industry leaders convened for the Global Regulatory Town Hall—a long-standing and popular feature of the annual event. The discussion focused on the growing impact of digitalization and the increasing use of artificial ...