Feature: Cell and gene therapies (C>s) offer a groundbreaking approach for disease treatment by targeting conditions at the cellular and genetic level, offering hope for previously untreatable disorders. As these therapies progress from clinical trials to commercial reality, manufacturing challenges—particularly the need for robust, scalable, and cost-effective production—remain a significant barrier to widespread patient access.
Feature: Mold contamination is one of the most persistent threats to cleanroom integrity in pharmaceutical manufacturing. This article highlights the sources, growth conditions, and pathways for mold ingress. It emphasizes the need for an integrated approach combining facility design, environmental monitoring, effective investigation, and robust cleaning and sanitization programs.
Technical: This article presents experiences from seven recent accelerated development program case studies. These experiences provide insights that could help companies progressing through accelerated development programs for products meeting unmet medical needs or significant therapeutic needs, such as those with anticipated Breakthrough Therapy (United States) or PRIME (European Union) designation.
Technical: This article examines the regulatory landscape governing artificial intelligence (AI) in qualitycritical systems and distinguishes between algorithms, AI, and a nuanced middle category called smart systems. It explains how organizations can responsibly embrace advanced programmatic solutions while preserving the integrity of validated test methods and safeguarding patient safety.
Technical: Shelf temperature mapping is a critical component of lyophilizer qualification. The previous articles in this series explored the methods used to record the shelf surface temperatures (Part I) and designing an appropriate study (Part II). Interpreting a shelf temperature mapping study’s result is as critical to assessing uniformity as the temperature measurement, the study design, and the execution.
Cell and gene therapies (C>s) offer a groundbreaking approach for disease treatment by targeting conditions at the cellular and genetic level, offering hope for previously untreatable disorders. As these therapies progress from clinical trials to commercial reality, manufacturing challenges—particularly the need for robust, scalable, and cost-effective production—remain a significant...
Mold contamination is one of the most persistent threats to cleanroom integrity in pharmaceutical manufacturing. This article highlights the sources, growth conditions, and pathways for mold ingress. It emphasizes the need for an integrated approach combining facility design, environmental monitoring, effective investigation, and robust cleaning and sanitization programs.
This article presents experiences from seven recent accelerated development program case studies. These experiences provide insights that could help companies progressing through accelerated development programs for products meeting unmet medical needs or significant therapeutic needs, such as those with anticipated Breakthrough Therapy (United States) or PRIME (European Union) designation.
This article examines the regulatory landscape governing artificial intelligence (AI) in quality-critical systems and distinguishes between algorithms, AI, and a nuanced middle category called smart systems. It explains how organizations can responsibly embrace advanced programmatic solutions while preserving the integrity of validated test methods and safeguarding patient safety.
Shelf temperature mapping is a critical component of lyophilizer qualification. The previous articles in this series explored the methods used to record the shelf surface temperatures (Part I) and designing an appropriate study (Part II). Interpreting a shelf temperature mapping study’s result is as critical to assessing uniformity as the temperature measurement, the study design, and the...
Bulk powders inherently exhibit unpredictable flow in feeders, dosing machines, and packed machines under gravity's pull. Meanwhile, particle engineering co-processed excipients can be more versatile and economical compared to conventional ingredients in the continuous manufacturing of drug products.
The promise of single-use technologies (SUTs) in biopharmaceutical manufacturing is as compelling as it is contradictory. Noted for accelerating process development, enhancing sterility, and enabling unprecedented manufacturing agility, SUTs have also introduced a less visible but mounting challenge: the steady accumulation of complex plastic waste.
ISPE’s FOYA program recognizes state-of-the-art projects using innovative technologies to improve the quality of products, reduce the cost of producing high-quality medicines, and demonstrate advances in project delivery for the benefit of humanity.
The new ISPE Good Practice Guide: Continuous Manufacturing of Biological Products shows how continuous biomanufacturing (CBM) becomes compelling when it delivers reliable, scalable, decision-grade data that tie directly to financial outcomes and operational agility. It also provides regulatory considerations and life-cycle management concepts for the integration of future technologies that are...
In today’s life sciences landscape, process control systems (PCSs) have become the backbone of modern manufacturing. These computerized systems monitor and influence physical processes in real time, ensuring that safe, high-quality products reach patients around the world. Because PCSs often interact directly with equipment, facilities, and materials, they carry significant responsibility in...
In each issue of Pharmaceutical Engineering®, we introduce a member of the ISPE staff who provides ISPE members with key information and services. Meet Gabbi Jimenez, Graphic Designer, Marketing & Communications team.
The following insights were presented by Ib Alstrup, GxP-IT Medicines Inspector, Danish Medicines Agency, at the 2025 ISPE Pharma 4.0™ Conference on 9 December in Barcelona, Spain, and summarized.
Advanced therapy medicinal products (ATMPs) are redefining what’s possible in medicine, but their promise comes with a challenge the industry can no longer afford to postpone: how to scale manufacturing in a way that is cost-effective, resilient, and patient-ready.
ISPE has announced the establishment of the ISPE Radiopharmaceuticals Community of Practice (CoP). This initiative intends to respond to the rapid growth and unique complexities of the radiopharmaceuticals field, which is critically advancing precision medicine for conditions such as cancer.
Keeping women on the path to leadership requires access to opportunities, mentorship, appreciation, and flexibility.
The pharmaceutical industry has always promised meaningful work: molecules that become medicines, processes that protect patients, and careers built on rigor and purpose. Yet for ISPE student Chapter members and Emerging Leaders approaching graduation, breaking into that world has never felt more daunting.
Advanced therapy medicinal products (ATMPs) are now firmly part of the therapeutic landscape. Over the past decade, the number of approved cell and gene therapies has increased steadily—and so has our understanding of their clinical impact. For many patients, these therapies offer outcomes that were not previously possible.
This issue explores the evolving landscape of Advanced Therapy Medicinal Products (ATMPs), examining how innovation
