In pharma, AI’s biggest challenge isn’t technical, it’s cultural.
ISPE’s official blog, iSpeak accepts contributions from our Members and professionals in the pharma industry.
In pharma, AI’s biggest challenge isn’t technical, it’s cultural.
2025 marks a significant milestone for the ISPE Argentina Affiliate with its 20th anniversary—commemorating two decades of commitment to excellence, collaboration, and integrity within the Latin American pharmaceutical community.
Laboratory automation in the pharmaceutical industry is rapidly evolving due to increasing regulatory demands and the need for efficiency, flexibility, and data integrity. However, fragmented systems, proprietary protocols, and inconsistent validation frameworks continue to limit progress.
The pharmaceutical industry is at a crossroads. Legacy systems, manual workflows, and paper-heavy processes are slowing down innovation.
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...
In 2020, CSL initiated a benchmarking activity with a small group of peer companies identified through ISPE to explore creation and maturation of Asset Management programs at each company. The initial sessions were a success, covering topics such as Asset Condition Evaluations and Asset Management Governance. CSL was keen to continue the conversations and gather more insights on certain...
ISPE has once again assembled the most comprehensive industry conference on aseptic manufacturing that all should attend. The planning committee began their efforts within days of last year’s outstanding conference, with this year’s building upon the learning of last year. The speakers at this year’s conference are shaping the future of aseptic processing and sterile manufacturing. The
Pharmaceutical companies have changed their operational model to meet the growing demand for complex biopharmaceuticals. These changes have allowed the pharmaceutical industry to deliver more than just the most efficient and sustainable solutions. Beyond efficiency, the pharmaceutical industry has begun leveraging advanced technologies to reshape the drug discovery and development process...
Two members of the International Society for Pharmaceutical Engineering (ISPE) participated in a recent workshop organized by the National Academies of Sciences, Engineering, and Medicine (NASEM). The event, titled Improving Resiliency in the U.S. Pharmaceutical Supply Chain Through Make-Buy-Invest Strategic Actions, was held on 22–23 October in Washington, D.C., USA, and via remote access....
On 20–21 October 2025, ISPE’s Enabling Pharmaceutical Innovation initiative team partnered with Brazil’s National Health Surveillance Agency (ANVISA) to host a workshop focused on innovation and regulatory harmonization in Latin America. The event aimed to explore opportunities for industry to work together with ANVISA and other health authorities to reduce obstacles and encourage innovative...
Laboratories are among the most resource-intensive environments, consuming large amounts of energy, water, and chemicals while providing much needed healthcare solutions to the community. It is important that an organization’s focus on go green initiatives trickles down all the way to how the laboratories handle their reagents, consumables, their instruments, laboratory process while...
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, tailored to individual needs, and produced with resiliency against shortages. Emerging models like...
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 intelligence (AI) by both regulators and industry. The session featured a mix of pre-prepared...
The 2025 ISPE Pharma 4.0™ Conference will take place from 9–10 December in Barcelona, Spain, and virtually. In the video and transcript that follows, International Program Committee Member Alicia Tébar, General...
The 2025 ISPE International Honor Awards were hosted in Charlotte, North Carolina, USA at the 2025 ISPE Annual Meeting & Expo. Taking place during the Membership Meeting and Awards Lunch, the ceremony...
The 2025 ISPE Singapore Conference and Exhibition, hosted by the ISPE Singapore Affiliate, took place 27–29 August at Suntech Singapore. It is one of the largest and most well-regarded events for...