This year, the ISPE Foundation’s Professional Development Grants program, supported by the Moderna Foundation, enabled 24 STEM students and Emerging Leaders to attend the 2024 ISPE Annual Meeting & Expo with all expenses covered.
The 2024 ISPE Pharma 4.0™ and Annex 1 Conference will be held 10–11 December in Rome, Italy, and virtually. Richard Denk and Line Lundsberg-Nielsen, the conference’s Executive Chairs, offer advice...
Established in 2004, the Facility of the Year Awards (FOYA) recognize state-of-the-art projects utilizing new, innovative technologies to improve the quality of products, reduce the cost of producing high-quality medicines, and demonstrate advances in project delivery.
Single-use products used in the production of biologics provide flexibility that was unimaginable a few years ago. The implementation of single-use technology (SUT) in manufacturing operations has accelerated due to reduced risk, flexible process equipment adjustments, and lower capital cost. The widespread use of this technology has raised questions about its impact on the environment due to...
Many organizations are on the right path to sustainability, but more can still be done— especially for setting and meeting net-zero targets. Although a commitment to net-zero operations is important for all industries, it’s particularly necessary for the pharmaceutical industry, with its high energy consumption, high water demands, and the use of solvents for manufacturing.
Traditionally, a regulated company is accountable for all aspects of their infrastructure qualification and application validation. With the introduction of public cloud service providers (CSPs), part of that technical responsibility has shifted to a cloud supplier, making supplier assessment and supplier management more important than ever—even though the regulated company is still...
Reducing the pharmaceutical industry’s carbon footprint has become a management responsibility. This article introduces some of the key points, actual methods, and practical examples of our implementation to reduce carbon emissions from pharmaceutical manufacturing facilities in Southeast Asia.
This article describes the numerous activities in the commercial quality control (QC) network that aim to replace in vivo assays with alternative methods in the course of production and release.1
This article presents a comprehensive analysis of plastic waste generation in the biopharmaceutical industry, focusing on using single-use technologies (SUT) in bioprocessing for monoclonal antibody (mAb) production. It aims to inform sustainable practices within the biopharmaceutical industry and to encourage the development of more sustainable disposable technologies.
I am enthusiastic and humbled to have the opportunity to author a column on leadership for the ISPE membership. The subject of leadership has been a passion of mine since the very start of my career, 45 years ago. From the shop floor to the C-suite, I have been an ardent student of the subject.
