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 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...

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.

When I began my journey in the pharmaceutical industry over 25 years ago, the environment was markedly different from what we see today. We operated in a world dominated by paper-based systems, outdated training videos from the 1980s, and a heavy reliance on self-directed reading. Career progression was more about navigating an informal ladder—gaining experience, demonstrating capability, and...

Nina S. Cauchon is Director Regulatory Affairs (RA) Chemistry, Manufacturing, and Controls (CMC) at Amgen Inc. where she leads RA-CMC advocacy and external engagement. She has experience leading both early phase and commercial programs, including small molecules and biologics. Her areas of interest are regulatory challenges for innovative modalities and emerging technologies, CMC aspects of...

Celeste Frankenfeld Lamm encourages young professionals to identify and pursue the aspects of their jobs they feel passionate about, “The things that get you out of the bed in the morning tend to be the areas where you are going to perform strongly. Once you’ve identified them, it’s important to make your own opportunities. Let leadership know your work passions, express interest in teams or...

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...

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&GT) 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&GTs 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...