Issue List

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...
Risk Management in Single Use Technology Cover: Risk management is pervasive throughout the biopharmaceutical industry. It is an important factor during the implementation of new equipment or procedures into an operation...
Improving Pharmaceutical Connections with Patients Cover: Delivering pharmaceutical solutions to patients may be more effective with new developments in digital delivery and tracking. This follow-up on a presentation at...
A control strategy developed using a science- and risk-based approach will ensure that reproducible product quality is achieved throughout the product life cycle, while maintaining the efficiency, robustness, and...
In recognition of the growth and importance of generics to the pharmaceutical market, Pharmaceutical Engineering takes a look at what’s happening in four global markets: India, China, Japan, and the Philippines...
Data integrity has been and continues to be an inherent aspect of global GMP regulations governing electronic and paper-based records in pharmaceutical manufacturing. Data Integrity in the Trenches Cover: Data integrity...
George Scangos, CEO of Vir Biotechnology, talks with PE about his thoughts on building a culture of innovation. The former Biogen head also talks about his latest endeavor, a biotech start-up waging war on infectious...
The first revision to Annex 1 in a decade has rebuilt and reorganized the document to align with GMP in Europe. Jean-François Dulière, ISPE Comment Team Lead, breaks down the details on the developments. Meet the Annex 1...
The Fourth Industrial Revolution Cover: Technology is advancing faster than ever. Rapid, major changes are on the horizon for just about everything—including manufacturing. Connectivity and artificial intelligence, along...
Biopharmaceuticals are booming in Asia, buoyed by enhanced regulations, an influx of venture capital, a culture of innovation, and government support. The Rise of Biopharmaceutical Manufacturing in Asia Cover...
Reining in Consumption for Sustainable Manufacturing Cover: The word “sustainability” is both overused and abused: We hear about sustainable development in a sustainable economy that uses sustainable packaging for a...
François Sallans, Vice President and Chief Quality Officer for Johnson & Johnson, speaks with PE about his career, dedication to preventing drug shortages, and thoughts on the ongoing hurricane-recovery efforts in Puerto...
Engineers looking to enter the biomanufacturing workforce may feel unprepared without a background in cell culture or chromatography. Crossing Over to Large Molecules: Bridges to Biomanufacturing Cover: We interviewed...
The cover story focuses on the first FDA-approved gene-transfer therapy, Novartis’s Kymriah, and other CAR T-cell products in development. Breakthrough for Industry and Patients Cover Story: On 30 August, the FDA...