Pharmaceutical Engineering Magazine

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 controls; and market strategies. A key enabler to success is establishing a robust yet nimble viral vector manufacturing platform that delivers high-quality product on time and in full while managing cos

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 advanced since then, and the article explores the importance of recognizing when an organization is relying on OSS and the benefits and risks this brings from a GAMP® 5 perspective.

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 and the industry. This article looks at the history of the group, its purpose, current and future initiatives, and a name change that better reflects the path of its members.

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...

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...