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ISPE’s official blog, iSpeak accepts contributions from our Members and professionals in the pharma industry.  

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iSpeak Blog
Building on the discussion in Part One about the need for standardization across research and development (R&D) and quality control (QC) laboratories, this second part of the series explores how laboratories can progress toward plug-and-play automation.
iSpeak Blog

Pharma companies are currently experiencing unprecedented challenges as a result of external factors such as geopolitics, the adoption of new modalities, rapidly changing technologies including digital ones, and also regulatory changes. In order to overcome these challenges, the pharmaceutical industry must accelerate and embrace new technologies, approaches and thinking. Hence to grow and...

iSpeak Blog

The 2025 ISPE International Honor Awards were held during the Membership Meeting and Awards Lunch during the 2025 ISPE Annual Meeting & Expo in Charlotte, North Carolina, USA. The ceremony recognized ISPE members and contributors whose dedication and service exemplify what it means to Shape the Future of Pharma™. The Emerging Leader Member of the Year Award was presented to Ryan Mazur and...

iSpeak Blog
Explore three insightful sessions on the future of pharmaceutical facilities from thought leaders who presented at the 2025 Facilities of the Future Conference: “A New Standard for Designing Agile Manufacturing Facilities,” “Executive Forum Dinner and Panel Discussion,” and “Lilly’s Manufacturing Innovation to Reach More Patients.” These videos feature expert perspectives on flexible design, the...
iSpeak Blog

The evolution of pharmaceutical manufacturing has progressed through several stages—from manual drug compounding to fully automated lines with rigorous quality control. Today, a new era—Pharma 4.0™—is unfolding, offering both transformative opportunities and complex challenges driven by market needs, regulatory requirements, and rapid digital innovation.

iSpeak Blog
The rapid rise of cellular therapies is transforming modern medicine and creating new challenges for manufacturers. Unlike traditional biopharmaceuticals, cell-based products demand innovative approaches to aseptic processing, process closure, automation, and scalability. To address these complexities, ISPE and its ATMP Community of Practice have developed a comprehensive ISPE Guide on Equipment...
iSpeak Blog
The 2025 ISPE International Honor Awards occurred amidst the 2025 ISPE Annual Meeting & Expo hosted in Charlotte, North Carolina, USA from 26–29 October. The ceremony, which took place on 28 October during the Membership Meeting and Awards Lunch, honored ISPE members and contributors whose dedication and service exemplify what it means to Shape the Future of Pharma™. The Committee of the Year...
iSpeak Blog

Pharmaceutical manufacturing faces mounting pressure to comply with stringent regulatory requirements while maintaining the highest standards of quality, speed, and efficiency. As digital transformation revolutionizes industries, artificial intelligence (AI) is emerging as a critical driver of change in reshaping how pharmaceutical companies operate. This article continues our exploration of...

iSpeak Blog

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...

iSpeak Blog

P&ID walk-downs are a critical activity during commissioning and qualification (C&Q) turnover, ensuring that physical installations align with the design intent. Traditionally, this process relies on manual checks using printed drawings, which is labor-intensive and prone to human error. Although digital platforms exist across design, engineering, construction and turnover...

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