Industry 4.0 applications in biopharma involve the complete spectrum of data science throughout the entire product life cycle of many disparate entity types. Tools such as digitalization, modern data science, and the industrial internet of things are becoming requirements for modern implementations including advanced therapy medicinal products (ATMPs).
A Vision for ICH Q12: Current Experience, Future Perspectives Cover: Management of global postapproval chemistry, manufacturing, and controls changes...
ISPE has been honored as the winner of a 2021 APEX Award for Publication Excellence in the COVID-19 Media Government/Association content category for the four-article Special Report on COVID-19 impact published in the July-August 2020 issue. The APEX...
Opportunities in Continuous Manufacturing of Large Molecules Cover: Continuous manufacturing has attracted significant interest over the past decade...
IT Services: Applying Good IT Practice and Automation Cover: This article focuses on pragmatic quality- and risk-based approaches to IT infrastructure...
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 SIG addresses how pharmaceutical industry stakeholders, including regulatory authorities, can achieve benefits from Pharma 4.0™ initiatives.
Women in Pharma®: Empowering Women as Industry Leaders Cover: Women in Pharma® is a place where women and men—especially those new to the industry—can...
Cell and Gene Therapy Facility Design Using Simulations Cover: Designing new facilities for cell and gene therapy manufacturing is a challenging task...
In honor of the 40th birthday of ISPE and Pharmaceutical Engineering®, we looked back to 2010 to see what technology-focused articles were published in the magazine. Here are just a few:
Technology Trends: The Transition to Digitalization Cover: In the pharmaceutical industry, digitalization involves developing and implementing digital...
