Sustainability principles can be effectively integrated into commissioning and qualification (C&Q) projects to support environmental goals without compromising compliance, quality, or patient safety. By positioning C&Q as both a verification tool and an enabler of sustainable intent, this article outlines a practical path for the pharmaceutical sector to enhance operational efficiency,...

The pharmaceutical industry’s embrace of digital technologies and sustainability is no longer a competitive advantage, but an operational necessity. As Pharma 4.0™ matures, its integration will be vital for achieving net-zero objectives and achieving pharmaceutical excellence.

Crafting a sustainable packaging strategy for the pharmaceutical industry is complex and requires balancing environmental responsibility with regulatory compliance and operational costs. In this article, we explore the key drivers, challenges, and best practices for developing such a strategy.

The development of platform drug delivery devices for combination products offers a transformative approach to drug delivery by enabling the reuse of device data across multiple drug and device combinations.

Oligonucleotide therapies hold great promise for treating a wide range of diseases, including the undruggable, but their journey from lab to patient hinges on fundamental manufacturing challenges that the industry is racing to solve.

Michelle Vuolo is currently Head of Quality at Tulip Interfaces, Inc., a platform developer that enables manufacturers of many industries to build digital content to manage their operations. Before joining Tulip, Michelle spent more than 24 years in the biopharmaceutical and medical devices industries in quality control (QC) laboratories, engineering technical support, quality assurance...

Stephanie Stärkle is a project engineer at VTU Engineering in Switzerland, where she leads engineering projects from concept to execution in GMP-regulated environments including cost estimation, equipment design and specification, deadline management, and coordination with cross-functional stakeholders such as vendors, quality assurance, operations, and qualification. She holds a bachelor’s...

Water and steam are essential in the pharmaceutical industry. Both are used for multiple purposes, including cleaning and sterilizing equipment, laboratory activities, and as an ingredient.

When I began my career as an engineer in a major pharmaceutical company, I worked in an engineering department filled with highly experienced senior engineers. I admired their depth of knowledge and the way they had accumulated a wealth of practical information over decades. Their grasp of systems, processes, and equipment was impressive and humbling. I found myself anxious to build that same...

Advancements in technology—such as process intensification, continuous manufacturing, and 3D printing—are enabling transportable and point-of-care (PoC) medicines manufacturing, especially with the rise of personalized medicine. Modular, small-scale production systems are particularly well-suited for cell and gene therapies and other advanced therapy medicinal products (ATMPs) designed for...

In April 2023, ISPE launched a survey to understand the sources of barriers to technological innovation within the pharmaceutical industry. This survey is part of an expansive and significant initiative by ISPE, Enabling Global Pharma Innovation: Delivering for Patients, which aims to promote consistent and harmonized interpretation and implementation of guidelines issued by the International...

Defining requirements for calibration and routine testing of weighing equipment in the laboratory and production remains a complex endeavor for pharmaceutical companies. Applying sound, risk-based metrological strategies across the entire pharmaceutical value chain will help manufacturers ensure compliance, consumer safety, and commercial success.

The United States Pharmacopeia (USP) Packaging and Distribution Expert Committee approved chapters 665 and 1665 in 2024. These chapters establish clear and general guidelines for the use of plastic materials in process equipment used within the pharmaceutical and biotechnology industries. Their publication has raised new questions regarding the role of polymeric materials in manufacturing...

The increasing digitalization of the pharmaceutical and medical device industry has created novel cybersecurity challenges, particularly with the rapid advancement of artificial intelligence (AI) technologies. This article examines the dual nature of AI as both a potential threat vector and a powerful defensive tool.

The move to digital transformation represents a true paradigm shift in manufacturing, enabling organizations to leverage advanced technologies such as the Industrial Internet of Things (IIoT), cloud computing, and artificial intelligence (AI) to ensure compliance and secure a competitive advantage. This article presents a working definition of digital transformation, the components involved in...

Pharmaceutical companies can use digital maturity assessments to address the challenges of upgrading brownfield facilities and implementing digital transformation improvements. Enabled by stakeholder workshops, these assessments can rapidly produce concrete plans and priorities to guide a facility’s development over the next three to five years—delivering business value and laying the...

Pharma 4.0™ is a reference framework tailored to the pharmaceutical industry, guiding its digital transformation. Although many of today’s processes generate sufficient data to enable advanced use cases, structured guidance for transformation is often lacking. To address this, the ISPE Pharma 4.0™ Subcommittee on Process Data Maps and Critical Thinking has introduced an approach to help...

The often-overlooked function of chemistry, manufacturing, and controls (CMC) holds tremendous potential to reshape the landscape of drug development. By embracing innovation and rethinking traditional approaches, CMC has the rare opportunity to drive transformative changes that could significantly accelerate the journey from initial concept to a fully realized therapy. This offers the...