The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guideline on Registration of Pharmaceuticals for Human Use (M4) offers advantages in the consistent format of...
ISPE held an Expert Xchange on 18 January 2022 that included presentations and interactive exercises that generated new and useful insights into the current effectiveness of the knowledge that flows into QRM and how a...
Realizing the promise of any novel viral vector therapeutic depends on the innovator’s ability to constantly meet evolving program requirements set in the product’s preclinical; clinical; chemistry, manufacturing, and...
This article aims to refresh information on open-source software (OSS) within regulated computerized systems that was first discussed in an article in May-June 2010 Pharmaceutical Engineering®. The adoption of OSS...
Emerging Leaders has grown from an initiative for interactions among early-career professionals and entering ISPE into much more: a training ground, a networking organization, and a new foundation for the future of ISPE...
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...
A Vision for ICH Q12: Current Experience, Future Perspectives Cover: Management of global postapproval chemistry, manufacturing, and controls changes is a growing challenge for industry with many issues. ICH Q12...
Opportunities in Continuous Manufacturing of Large Molecules Cover: Continuous manufacturing has attracted significant interest over the past decade for small molecules formulated as drug products. The case for adopting...
IT Services: Applying Good IT Practice and Automation Cover: This article focuses on pragmatic quality- and risk-based approaches to IT infrastructure. It covers recommendations made by a US FDA/industry team linked to...
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...
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 access a network of mentors, role models, and educational resources...
Cell and Gene Therapy Facility Design Using Simulations Cover: Designing new facilities for cell and gene therapy manufacturing is a challenging task given the many uncertainties in this industry sector. One approach to...
Technology Trends: The Transition to Digitalization Cover: In the pharmaceutical industry, digitalization involves developing and implementing digital technologies at all levels of pharmaceutical operations. The aim is...
2020 ISPE Barrier Survey: Tracking the Journey of Barrier Technology Cover: For over two decades, the ISPE Barrier Isolator Survey has gathered meaningful data on the applications of barrier technology and has been a...
Regulatory Trends: ICH Q12’s Impact on Product Life-Cycle Management Introducing ICH Q12: A Transformational Product Life-Cycle Management Guideline Cover: The ICH Assembly endorsed the Q12 guideline, “Technical and...
This issue of Pharmaceutical Engineering looks at an array of sustainability topics. Sustainability & the Life Sciences Industry: A Global Introduction Cover: This introductory article surveys topics that will likely...
Introducing Industry Leaders: Pharmaceutical Engineering® is launching a new series of profiles of industry leaders. This ongoing series will look at the lives and careers of individuals who are changing the face of the...
Cell and Gene Therapies and Their GMP Requirements Cover: Cell and gene therapies are the latest revolution in medicine manufacturing. Unlike small molecules or traditional biotech products, these therapies introduce...