Pharmaceutical Engineering July/August 2025 Cover

Downloads

Issue PDF (44.4 MB)

The AI Paradox

Cover: 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.

Digital Transformation: Developing a Fully Automated Pharma Manufacturing Facility

Feature: 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 trans-formation, the components involved in undertaking a transformation initiative, and a phased approach to implementing digital transformation for the pharmaceutical industry.

A Pharma 4.0™ Future for Brownfield Challenges

Feature: 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 foundation for continuous improvement.

Applying Process Data Mapping Methodology for Systematic and Sustainable Transformation Toward Pharma 4.0™

Feature: 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 organizations develop a holistic perspective on transformation.

Visual Inspection Is Key to Ensuring Patient Safety in US Pharmaceutical Compounded Products

Technical: Visual inspection is nothing new to professionals who make, prescribe, prepare, and/or administer pharmaceutical parenteral products to patients of all backgrounds, especially those who may have immunity concerns. The pharmaceutical industry has tried to ensure that companies enact the best quality standards that are consistent with Current Good Manufacturing Practices (CGMPs) to prevent an adulterated product from entering the market.

In This Issue

Features

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.

Features

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...

Features

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...

Features
The complex transformation toward Pharma 4.0™ requires comprehensive skill management. This case study builds on a previously presented framework and follows the fictional company NewCo as it tackles the challenge of developing a future-ready workforce during a plant expansion project. Guided by the framework, NewCo first establishes skill management governance and a cross-functional team. It...
Technical

Visual inspection is nothing new to professionals who make, prescribe, prepare, and/or administer pharmaceutical parenteral products to patients of all backgrounds, especially those who may have immunity concerns. The pharmaceutical industry has tried to ensure that companies enact the best quality standards that are consistent with Current Good Manufacturing Practices (CGMPs) to prevent an...

Features

Informed consent aims to provide clinical trial participants with transparent education about the trial’s objectives, potential risks and benefits, and procedural requirements. As clinical trial designs evolve to include decentralized and adaptive elements, the informed consent process becomes increasingly complex. In response, this article explores the potential application of AI-powered...

Insights

Companies must proactively build a healthy culture, as it lays the foundation for organizational success. Those that foster a culture of innovation, dedication, and enthusiasm among employees are best positioned to achieve sustained success.

Features

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...

Features

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...

Features

The ISPE Baseline® Guide Vol 8: Pharma 4.0™ was published in December 2023 to help accelerate the adoption of digital transformation. In quoting the opening narration of the original 1960s Star Trek television series, Christian Wölbeling, Founder and Chair of the ISPE Pharma 4.0™ Community of Practice, likes to say, “To boldly go where no one has gone before.”

Features

With the help of Digital Twins, companies can achieve greater certainty and precision in making informed decisions at various stages of the product lifecycle, driven by a deep understanding of underlying Critical Business Parameters (CBPs).

Insights

Talk show host Oprah Winfrey once said, “A mentor is someone who allows you to see hope inside yourself.” Mentoring can be a powerful force in shaping an individual’s professional career and growth in a profound way. For some of us, we would not be where we are today without the wisdom and guidance of a mentor.

Insights

ISPE is dedicated to advancing AI and digital transformation for the industry. The ISPE International Board of Directors fully supports this initiative. We are making significant strides in supporting the pharmaceutical industry’s pursuit of digital transformation, including the exploration and potential strategic implementation of AI.

InTouch

The pharmaceutical industry is experiencing a significant talent shortage, particularly in the areas of manufacturing and regulatory affairs. As innovation in biotechnology, artificial intelligence, and personalized medicine accelerates, the demand for a highly trained workforce continues to outpace supply.

InTouch
During his welcome address on 12 May in London at the 2025 ISPE Europe Annual Conference, Mike Martin, President and CEO of ISPE and the ISPE Foundation, set the stage for what would become the most well-attended Europe Annual Conference to date, drawing 1,200 participants. He opened the conference by sharing how his background as an engineer has shaped his involvement with ISPE. While...
InTouch

ISPE participated in a Good Manufacturing Practice and Good Distribution Practice Inspectors Working Group (GMDP IWG) meeting hosted by the European Medicines Agency (EMA) on 13 March. The group included global stakeholders, including senior inspectors from across Europe and observers from global regulatory bodies such as the US Food and Drug Administration (FDA) and the World Health...

InTouch

This year, the ISPE Singapore Affiliate proudly marks 25 years of advancing pharmaceutical engineering and technology. It has played a pivotal role in shaping the pharmaceutical and biopharmaceutical industries in the region, fostering a strong community focused on education, collaboration, and innovation. As we reach this remarkable milestone, we reflect on the journey and look ahead to an...

InTouch

Ben Stevens serves as Director of Chemistry, Manufacturing, and Controls (CMC) Policy and Advocacy at GSK. He has over 15 years of experience in the industry having worked for Alnylam Pharmaceuticals where he led the global CMC regulatory development of vutrisiran (a treatment for polyneuropathy and cardiomyopathy), and oversaw its US New Drug Application and the EU Marketing Authorization....

InTouch

As the Senior Director of Personalized Supply Chain at Cencora World Courier (formerly AmerisourceBergen), Andrea Zobel leads the cell and gene therapy (CGT) and direct-to-patient service lines for this specialty logistics provider. With a background that includes experience gained across academia, pharmaceutical services, and clinical trials logistics, Andrea focuses on defining strategy,...

InTouch

In each issue of Pharmaceutical Engineering®, we introduce a member of the ISPE staff who provides ISPE members with key information and services. Meet Katie LeChase, Director of Communications.

Features
From AI paradoxes to Pharma 4.0™ breakthroughs, this issue of Pharmaceutical Engineering explores the digital frontier of pharmaceutical manufacturing. Discover how avatars, digital twins, and strategic skill-building are reshaping the industry—while visual inspection and cybersecurity remain critical. Innovation meets practicality in a future-ready edition packed with insight, strategy, and...