Digital transformation and digitalization are on the agenda for all organizations in the biopharmaceutical industry. But what are the main enablers of intelligent manufacturing? We hypothesize that data science–derived manufacturing process and product understanding is the main driver of digitalization in the bioprocessing industry for biologics manufacturing. In this article, the first of a...
During the ISPE Pharma 4.0™ Virtual Conference, the Management Communication working group of the ISPE Pharma 4.0™ Special Interest Group (SIG) held a workshop to support ISPE members in pitching,...
Through this difficult time of the COVID-19 pandemic, ISPE has remained active. At the 2020 ISPE Pharma 4.0™ Virtual Conference, 17–18 November, 174 attendees gathered online to discuss and learn about...
The fourth Industrial Revolution (also known as Industry 4.0) is the era of smart machines, storage systems, and production plants that can autonomously exchange information, trigger actions, and control operations free of any human intervention. To ensure future success in the delivery of therapeutic medicines to patients, it is imperative that the pharmaceutical industry move deeper into the...
The ISPE Pharma 4.0™ Special Interest Group (SIG) launched in 2015 to provide a road map for new challenges of digitalization, Industry 4.0, and the smart factory. The Special Interest Group addresses how pharmaceutical industry stakeholders, including regulatory authorities, can achieve benefits from
Understanding and utilization of Pharma 4.0™ technologies will be critical for students and Emerging Leaders (ELs) as they develop in their careers in the pharmaceutical and life sciences industries. To learn more, I spoke with Edoardo Schiraldi, an Emerging Leader based in Florence, Italy, who works as a Corporate R&D Business Solutions Specialist with Menarini Group, about the “pillars”...
The Life Sciences industries adhere to strict documentation practices to prove quality and compliance. We’re all familiar with the truism “If it isn’t written down, it didn’t happen.”
What is Pharma 4.0? It is a vision of a holistic company-wide transformation, which balances and combines: productivity, quality, and robustness based on a data-centric perspective.
As Pharma 4.0™ increasingly becomes reality, our validation practices must change. We can no longer apply 20th-century thinking to 21st-century technology and resources. Validation must adapt to industry shifts from iterative to...
