ISPE’s official blog, iSpeak accepts contributions from our Members and professionals in the pharma industry.
As industries across the globe navigate increasing complexity, consumer expectations, and regulatory pressures, the traditional boundaries of quality management are being pushed. Quality is no longer just a post-production checkpoint—it has become a strategic pillar that spans the entire product lifecycle. In this transformative landscape, artificial intelligence (AI) is emerging as a powerful...
In Pharma 4.0™, quality should no longer be reactive—it’s predictive, connected, and embedded in daily operations. The 2025 ISPE Pharma 4.0™ Conference, taking place 9–10 December in Barcelona, Spain, and...
C&Q forms a critical connection between the construction phase and operational readiness of pharmaceutical manufacturing facilities. Despite C&Q’s important role in regulatory compliance, many project leaders are not prioritizing this phase, treating it as optional, low value added, or merely a paperwork exercise. This situation can exist in engineering, procurements, and construction...
Continuous manufacturing (CM) of oral solid dosage forms has become a well-established approach that offers multiple benefits in the production of pharmaceutical oral solid dosage forms as compared to traditional batch manufacturing. CM continues to offer opportunities for faster development and time to market, enhanced process robustness, improved quality assurance, and greater operational...
The pharmaceutical industry is under constant pressure to expand capacity, accelerate time-to-market, and ensure reliable access to critical medicines. As more therapies gain regulatory approval and blockbuster drugs scale rapidly, the need for smarter, more resilient facilities has never been greater. That is why ISPE is particularly excited about the Innovative Facility Design track at the...
The 2025 ISPE Annual Meeting & Expo is set for 26–29 October in Charlotte, North Carolina, USA and virtually. ISPE invited conference committee members, Peter Millili, Senior Director, Manufacturing...
The pace of innovation—digital joined with operational excellence—in the life sciences industry shows signs of improvement. Artificial intelligence, robotics, advanced analytics, smart facilities design and innovation culture are no longer “future concepts”—they are deeply transforming pharmaceutical development, manufacturing and the whole supply chain. Alongside many exciting opportunities...
Advanced therapy medicinal products (ATMPs) represent a revolutionary frontier in medicine, offering life-changing treatments for conditions previously deemed incurable. However, the intricate nature of these therapies, from their unique raw materials to complex manufacturing and logistics, presents significant challenges and inherent risks including how to best develop validation methods and...
This year’s ISPE Germany/Austria/Switzerland (D/A/CH) Affiliate workshop, “Pharma’s Journey to Digital Manufacturing and Supply,” united pharma leaders, technology experts and regulatory agencies for three days of intense exchanges on the digital transformation of our industry. Its innovative, highly interactive format enabled all 130 participants to engage, contribute, and learn from each...
A Message from the President and CEO, ISPE, on the 2025 ISPE Boston Product Show
Engineers know that data is only as valuable as the decisions it drives. The Data-Driven Manufacturing Excellence Solutions track at the 2025 ISPE Pharma 4.0™ Conference will showcase how pharma organizations...
The 2025 ISPE Annual Meeting & Expo, ISPE’s largest event of the year, is quickly approaching, taking place 26–29 October in Charlotte, North Carolina, USA and virtually. In the videos and transcripts...
Bayer, a global leader in the pharmaceutical industry, is committed to advancing healthcare through innovative solutions. With their new Cell Therapy Launch and Manufacturing Facility, Bayer aims to provide hope to patients with unmet medical needs by finding a cure and making life-changing therapies more accessible to all. The facility signifies a major advancement in the production and...
Artificial Intelligence isn’t just theory anymore—it’s revolutionizing pharmaceutical operations today. At this year’s 2025 ISPE Pharma 4.0™ Conference, the AI Case Studies: Benefits and Challenges track...
