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...
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.”
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).
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...
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...
The 2025 Facility of the Year Awards (FOYA) category winners were announced in May at the ISPE Europe Annual Conference held in London, England. As FOYA celebrates its 20th anniversary this year, it honors 17 finalists whose projects span 12 countries and five continents—a true global showcase of innovation.
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,...
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....
Cell therapies, especially autologous chimeric antigen receptor T cell (CAR T cell) treatments, are transforming personalized medicine, bringing new hope to patients with conditions once thought untreatable. However, the manufacturing processes for these therapies remain predominantly manual, presenting significant challenges in scalability, consistency, and making these treatments more widely...
Advanced therapy medicinal products (ATMPs), which include cell and gene therapy (C>) products, frequently require handling steps between quality control release and patient administration. These steps take place directly at the point of care and are especially critical for C>s with limited shelf life after preparation.
Advanced therapy medicinal products (ATMPs) have the potential to treat life-threatening, incurable conditions. But access to these therapies remains challenging due to the nature of current ATMP manufacturing models. This article explores solutions, focusing on standardized processing and shared knowledge as gateways to automated, robotic manufacturing and decentralized production.
For patients who depend on personalized medicine, turnaround time matters. However, moving quickly is difficult for cell therapy companies because designing personalized therapies presents unique challenges unknown in traditional biotechnology. In this article, we’ll examine five strategies to help cell therapy companies develop resilience against these challenges, positioning themselves to...
Advanced therapy medicinal products (ATMPs) are transformative therapeutics that are realizing increasing gains in market approvals, yet are expensive products to produce. To enable a broader application of these medicinal products in the marketplace, the cost of goods (COGs) sold should be addressed early in development with a focus on reduction of cost to the patient.
A growing segment of the advanced therapy medicinal product (ATMP) landscape, which includes gene therapies and cell-based treatments, relies heavily on viral vectors for efficient gene delivery. The increasing demand for these therapies requires a robust, scalable, and cost-effective manufacturing solution.
Controlling contamination in environments where biological medicinal products are handled is of paramount importance to ensure the safety of personnel, sterility of drug products, and protection of the surrounding environment. The application of vaporized hydrogen peroxide (vH2O2) has emerged as a promising method for postproduction decontamination due to its ability to...
For companies focused on producing lifesaving treatments, the positive effects of employee health, well-being, and satisfaction can be easily overlooked, but those positive effects are real. An investment in people results in better research, testing, and manufacturing processes, which leads to more efficient delivery of therapies and treatment to patients worldwide.
Organizations must continually evolve and adapt in order to grow, sustain, and stay competitive. No organization survives for a long period of time if it does not change with the times. The pace of change is accelerating, and the scale of disruptive market forces is growing by the day.
This article describes a practical and pragmatic approach to the management of computerized system life cycle and information technology (IT) process records. The objective is to effectively achieve and maintain compliant GxP-regulated systems that are fit for intended use, and to support patient safety, product quality, and data integrity.
Currently, there is no single guidance document providing a comprehensive roadmap for executing digital validation. While elements from ISPE GAMP® Guides Series and the ISPE Baseline® Guide: Volume 8 – Pharma 4.0™, apply to digital validation, there is no consolidated resource addressing common questions. The authors of this Concept Paper therefore advocate for the development of a Good...
A set of principles to be considered in the journey to adopting and deploying an architecture capable of supporting Pharma 4.0 Plug & Produce capability.
The validation industry is entering a transformative era. Amid rising regulatory scrutiny, evolving team structures, and a strong push toward digitalization, professionals across the life sciences are being called to do more, with leaner teams and tighter timelines.
Explore June’s top reads in Pharmaceutical Engineering®—from cleanroom pressure design and AI validation to modular cell therapy manufacturing and ATMP access. Discover strategies for resilience, sustainability, and speed in pharma facility innovation.
The new ISPE GAMP® Guide: Artificial Intelligence provides a comprehensive, state-of-the-art best practice framework to efficiently and effectively achieve high-quality AI-enabled computerized systems in regulated life science areas. It bridges established GAMP concepts with...
Each year, FOYA showcases innovation, excellence, and progress in the pharmaceutical industry. The winners exemplify state-of-the-art design, cutting-edge technology, and industry best practices, continually setting new standards for what constitutes a winning project. This constant evolution keeps FOYA fresh and original, making it all the more remarkable that FOYA is celebrating its 20th...
The pharmaceutical industry is experiencing a pivotal transformation. As professionals strive to develop therapies faster, more cost-effectively, and with greater precision, Pharma 4.0™ emerges as a powerful framework for change. This evolution is not only technological—it is cultural. It challenges organizations to become more agile, data-driven, and patient-focused.
The pharmaceutical industry is under increasing pressure to develop new therapies at a faster pace, while lowering drug costs, enhancing quality, and maintaining safety and a robust supply chain. Validation 4.0 ensures that validation processes are not a bottleneck but a strategic enabler of innovation, quality, and compliance by embracing artificial intelligence (AI), Internet of Things...
As the pharmaceutical industry evolves, sustainability is becoming a key driver of operational efficiency and long-term success. From reducing carbon emissions to enhancing workforce safety, companies are aligning their practices with sustainability goals. The 2025 ISPE Annual Meeting & Expo is the ideal platform to exchange ideas and...
The pharmaceutical industry is no stranger to innovation. From pioneering drug development to advanced manufacturing processes, it thrives on new ideas. But when it comes to construction, particularly the delivery of critical infrastructure such as laboratories, cleanrooms, and research facilities, many companies in the sector still rely on traditional building methods.
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.
Like other industries, the pharmaceutical industry is struggling with pain points of inflation, economic and geopolitical uncertainty, and big waves of retiring employees—all factors that have barely been tackled.
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.
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.
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...
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...
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.
The 2025 ISPE Annual Meeting & Expo scheduled for 26–29 October in Charlotte, North Carolina, US, will give attendees the knowledge and expertise to tackle future challenges in the pharmaceutical industry while helping them connect with colleagues who will become invaluable professional resources.
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.
Sponsored content is the sole responsibility of the authors and is not endorsed, reviewed, nor a published article of Pharmaceutical Engineering® magazine or ISPE.
The FDA recommended CSA seeks to speed Computer System Validation (CSV) without sacrificing quality, but there’s a lot to know before you get started. This Kneat eBook, authored by CSV expert Darren Geaney, will give you a foundation of understanding so you can take the first step in your CSA journey with confidence.
Whether networking at events or collaborating through our Communities of Practice, the value of an ISPE membership is in the connections made between pharmaceutical industry professionals and Regulators to collaborate on solutions to common goals and challenges.
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