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Cell and gene therapy (C&GT) products represent a significant step forward in patient treatment and often offer unique patient benefits. However, product developers face significant hurdles within the regulatory landscape. The tools laid out in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q12 guideline: “Technical and...

Features

The US Food and Drug Administration (FDA) advocates for the integration of quality by design (QbD) principles throughout the pharmaceutical product development landscape, aiming to elevate both process understanding and product quality. Key challenges to the process control strategy include navigating time- and resource-intensive processes. One solution is digital shadow technology which, when...

Features

In the dynamic and highly regulated world of biopharmaceutical manufacturing, maintaining and ensuring quality is a critical success factor. An effective quality risk management (QRM) system is a key component in the overall quality management infrastructure of biopharmaceutical organizations. It offers a structured, scientific, and risk-based approach to decision-making, addressing potential...

Features

Advanced therapy medicinal products (ATMPs) and cell and gene therapies (C&GTs) represent a promising medical product class that employs gene therapy, cell therapy, or tissue engineering to address various diseases and injuries. One critical aspect of ATMP and C&GT manufacturing is using cell culture media. With thousands of ATMPs and C&GTs in clinical trial phases, the role of...

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Antibody engineering has transformed the development of therapeutic antibodies, enabling the creation of specific and effective treatments for a range of diseases. These antibody-based therapeutics are advancing in clinical development at a rapid rate and are being approved in record numbers. Currently, more than 100 monoclonal antibodies (mAbs) have been approved for the treatment of various...

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Laura-Ann Chin has more than 12 years of international and domestic contract and hands-on process engineering experience in the design and construction of current GMP facilities in the US, Europe, and Asia. She specializes in single-use solutions and modular technologies for scale-up, scale-out, and technology transfer in maximizing the performance of advanced therapy medicinal products,...

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Glenn Lawrence’s first position at Merck & Co. was as a shift engineer for a large factory in Rahway, New Jersey. It was a great learning ground for chemical processing and automation. Glenn was in operations when he was asked to join the engineering department, where he did plant design for active pharmaceutical ingredients and vaccines. He was then asked to take over the engineering...

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With the Chinese government initiating drug regulatory reform in 2015 and China joining the International Council for Harmonisation (ICH) in 2017, a significant number of measures have been implemented by the government. The aim is to make fundamental changes to China’s drug regulatory administration system so it can facilitate pharmaceutical development and better meet patient needs in the...

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Digital display labels (DDLs) offer an alternative solution to eliminate manual relabeling in the clinical supply chain, optimizing label content updates through a simple, system-controlled approach while providing new, uncharted opportunities. With increased efficiency in making regulatory-compliant changes and enhanced flexibility in the clinical supply chain, DDL technology has the...

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Due to the growing digitalization of the industry, we are highly dependent on information technology (IT) systems and data. The basic ability to execute our pharmaceutical business and decision-making processes relies on the permanent availability of these IT systems and data to ensure compliance and efficiency of our business operations. But numerous factors—including criminal activities,...

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IT infrastructure has traditionally been provisioned using a combination of scripts and manual processes. This manual approach was slow and introduced the risk of human error, resulting in inconsistency between environments or even leaving the infrastructure in an unqualified state. In this article, we investigate some fundamental advantages of using Infrastructure as Code (IaC) for...

Features

This article provides a brief introduction into the standards and regulations for medical devices. It compares the ISPE GAMP® 5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) and applicable ISPE GAMP Good Practice Guides against the relevant regulations and standards for the development of software for medical devices and demonstrates GAMP® 5 Second...

Features

Advanced therapy medicinal products (ATMPs) are one of the most promising developments in the pharmaceutical and biotech industries in recent decades. Although there is a great promise to treat and even cure many diseases with these products, there are also unique challenges, especially with their supply chains.

Features

Facility design decisions made early in conceptual design can have a significant impact on the cost of goods sold (COGS) in the manufacture of autologous and allogeneic cell therapy products. Understanding the impact of a COGS analysis is an important aspect of the early-phase design process.

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Live biotherapeutic products (LBPs) have the potential to treat a wide range of ailments. However, these living microorganisms are difficult to produce due to evolving government regulations and limited GMP manufacturing experience. New facility designs and more specific process guidance could help overcome these challenges. This article explores the nuances of facility design and regulatory...

Features

Cell and gene therapy (C&GT) products comprise a rapidly growing field of innovative medicines that hold the promise to treat and, in some cases, cure diseases that are otherwise untreatable. In this article, we provide points to consider when evaluating the comparability of C&GT when changes are made in their manufacturing processes.

Features

As the demand for accelerated access to medicines expands globally, the pharmaceutical industry is increasingly submitting regulatory applications in multiple countries simultaneously. As a result, Boards of Health (BoHs) are challenged with approving these applications in an accelerated timeframe and accommodating the submission of postapproval chemistry, manufacturing, and controls (CMC)...

Features

The new European Commission GMP Annex 1 “Manufacture of Sterile Medicinal Products” and the equivalent Annex 2 from the World Health Organization (WHO) triggered a discussion in ISPE’s Germany/Austria/Switzerland (D/A/CH) Aseptic Processing Community of Practice (CoP) Steering Committee about where to qualify air speed: “at working position” versus “at working level.” This article provides...

Features

The biopharmaceutical industry must develop and implement innovative ways of working to be effective and efficient in the current healthcare ecosystem, in which high-quality medicines, adaptability, and assurance of supply are of critical importance. There are regulatory strategies and technologies emerging to address these challenges, but further progress must be made to fully harness the...

Features

This article describes how ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) and related GAMP Good Practice Guides can be effectively applied to help meet the requirements of the proposed European Union (EU) artificial intelligence (AI) regulation for qualifying GxP-regulated systems employing AI and machine learning (ML).

Features

ISPE has launched an important new initiative, “Enabling Global Pharma Innovation: Delivering for Patients,” in support of the aspirations of many regulatory agencies globally to promote introduction of innovative pharmaceutical manufacturing.

Features

The creation of a new ICH guidance document, Q13,1

  • 1International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. “ICH Harmonised Tripartite Guideline Q13: Continuous Manufacturing of Drug Substances and Drug Products.” Published July 2021.
Features

Understanding and managing risks to continuous manufacturing (CM) technology is central to any decision to greenlight CM in a production-ready environment. Applying a systemwide risk management (SRM) approach to manufacturing is essential to ensuring manufacturing projects are vetted in a comprehensive and consistent manner.

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Latest Articles

iSpeak Blog

Novel therapies refer to innovative and often groundbreaking approaches to treating medical conditions. These therapies typically involve new modalities aiming to improve upon existing treatments or to provide entirely new options for patients. The development of novel therapies is not immune to the challenges of standard therapeutic pursuits; however, the use of automation can significantly...

iSpeak Blog

The outlook for the biopharmaceutical market is promising, with expectations that the market will double in the next 10 years, resulting in new therapies and advances in biopharmaceutical manufacturing. This doesn't sound like much at first, but if you consider how the market has developed over the last 20 years, a doubling in the next 10 years is very significant.

iSpeak Blog

The following blog post was provided by Peyton Myers, an undergraduate student at Appalachian State University. Myers attended the 2023 ISPE Annual Meeting & Expo in Las Vegas as an ISPE Foundation Professional Development Grant recipient.

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 Matt Lehmann, Custom Training Manager, Professional Development.

InTouch

One of the primary technical objectives of the ISPE Pharma 4.0™ Plug and Produce Working Group is to assist the Pharma 4.0™ digital transformation by enabling seamless integration and interoperability between all systems components and operational technology to advance the overall digital maturity toward predictive and adaptable operations.

InTouch

The ISPE Guide: Advanced Therapy Medicinal Products – Allogeneic Cell Therapy and the ISPE Guide: Advanced Therapy Medicinal Products – Recombinant AAV Comparability and Lifecyle Management were published earlier this year. These guides add to ISPE’s library of knowledge in the growing and ever-evolving advanced therapy medicinal products (ATMPs) field.

InTouch

Frances (Fran) M. Zipp was awarded the ISPE Joseph X. Phillips Professional Achievement Award at the 2023 ISPE Annual Meeting and Expo. The award is named in honor of Joe Phillips, longtime supporter of ISPE and a leader in establishing the Society as an “integrator” of industry and regulators, both during his years of service with the FDA and later when he became International Regulatory...

Insights

The emergence of new modalities and innovations on drug development and research, such as advanced therapy medicinal products (ATMPs) and personalized and precise therapies, presents new opportunities for the treatment and management of diseases and injuries. As these innovations continue to evolve, the regulatory landscape likewise evolves and this has led to the production of higher-quality,...

Insights

It is hard to believe that we are halfway through the year for the ISPE programs and the Board of Directors in 2024. We have continued to progress through the 2023–2025 ISPE Strategic Plan with engagement from Chapters, Affiliates, the ISPE Foundation, and ISPE committees and volunteers.

iSpeak Blog

The integration of data science in biopharmaceutical manufacturing, emphasizing data quality, tech transfer efficiency, and process optimization, is the heart of this track. Led by industry experts, discussions explore leveraging digital twins, predictive analytics, and continuous improvement initiatives. Additionally, interactive roundtable discussions provide attendees with a dynamic forum...

iSpeak Blog

The pharmaceutical sector stands at a crossroads of immense possibilities. We are witnessing an unprecedented surge in innovation, fueled by a remarkable partnership between industry and regulatory authorities. For example, there are initiatives fostered by the US Food and Drug Administration (US FDA) to promote innovation with programs such as CATT (CBER Advanced Technologies Team) and ETP...

iSpeak Blog

Through the ISPE Foundation Professional Development Grant program, Silas Tamufor attended the 2023 ISPE Annual Meeting & Expo in October 2023. Tamufor is a PhD student and ISPE Boston Chapter member who began serving as the ISPE Boston Educational Programs Committee Chair in December 2023. He, along with 87 other students and recent graduates, attended the conference thanks to the...

iSpeak Blog

To meet the biopharmaceutical industry’s duty to manufacture safe and effective therapies for patients, a robust quality system is fundamental to success. A quality system should link to quality culture and prioritize focusing on quality, led by management, that fosters sustainable compliance and consistent production of high-quality drugs. Strong quality culture attributes include a proactive...

iSpeak Blog

Stability sampling and testing are key to ensuring that products maintain safety, identity, strength, purity, and quality throughout their claimed shelf life. It is also a regulatory requirement per ICH Q5. However, storing product samples in different environmental conditions, testing those samples for three to five years (or more) after initial manufacture, and properly analyzing and...

iSpeak Blog

Biopharmaceutical facility design is a critical aspect of the industry. Overall cost pressures in the global health system, regional requirements to deploy manufacturing rather than centralize manufacturing in one location, technology enhancements in cell biology and format, flexibility to accommodate multi-product campaigns with different production schedules, and speed-to-market are among...

iSpeak Blog

The biotechnology industry continues to evolve, advancing the frontiers of science and engineering in the design, development, and manufacture of a wide variety of therapeutic modalities. Advances in cell and gene therapies continue to offer treatments for diseases that were previously uncurable, with seven approvals in 2023, including treatments for sickle-cell disease, hemophilia, type 1...

iSpeak Blog

The International Society of Pharmaceutical Engineering’s (ISPE) Women in Pharma® group was established in 2017. Since its inception, it has grown to a community of more than 2,000 members who are actively engaged in educational, collaborative, and networking activities designed to bridge gender, cultural, organizational, and geographic boundaries, maximize the impact women have in...

iSpeak Blog

Since starting with ISPE, Edyna Miguez, has had the incredible opportunity to connect with women across the globe working within the pharmaceutical industry, as part of the ISPE Women in Pharma® program. The tenure of these rising female leaders varies, as do their cultural backgrounds. However, one fact remains consistent: they are looking to make the industry a more equitable and...

Current Issue

May / June 2024

Front-End Design of Personalized Medicine Facilities Cover: The commercialization of personalized medicine has ushered in demand for a new type of facility— personalized medicine facilities—which can produce thousands of small-scale batches per year. There are currently only a handful of these sites, but many more are in various stages of design and construction. Designing these personalized...