This article describes the numerous activities in the commercial quality control (QC) network that aim to replace in vivo assays with alternative methods in the course of production and release.1
Reducing the pharmaceutical industry’s carbon footprint has become a management responsibility. This article introduces some of the key points, actual methods, and practical examples of our implementation to reduce carbon emissions from pharmaceutical manufacturing facilities in Southeast Asia.
The decision to pursue net-zero facility design in manufacturing is complicated. There are significant challenges related to initial project costs, physical space constraints, and project site considerations—but also substantive benefits from operational savings, environmental impact, building brand trust, and working toward a more sustainable future.
Single-use products used in the production of biologics provide flexibility that was unimaginable a few years ago. The implementation of single-use technology (SUT) in manufacturing operations has accelerated due to reduced risk, flexible process equipment adjustments, and lower capital cost. The widespread use of this technology has raised questions about its impact on the environment due to...
Traditionally, a regulated company is accountable for all aspects of their infrastructure qualification and application validation. With the introduction of public cloud service providers (CSPs), part of that technical responsibility has shifted to a cloud supplier, making supplier assessment and supplier management more important than ever—even though the regulated company is still...
For more than 22 years, James P. Wabby has dedicated his career to quality operations, regulatory compliance, and regulatory affairs pertaining to medical device technology, medicinal delivery platforms, complex generics, companion diagnostics, digital medicine, and combination product areas. In 2017, during one of the biggest regulatory changes within the European Union in over 20 years,...
Ester Lovsin Barle’s journey from veterinary lecturer in Slovenia to the Global Head of Product Sustainability and Stewardship at Takeda Pharmaceuticals in Switzerland was fueled by her curiosity and passion for continual learning and a desire to help others do the same. “We are never at the end of our learning curve, and it’s so important to continue to learn and be open-minded about new...
Established in 2004, the Facility of the Year Awards (FOYA) recognize state-of-the-art projects utilizing new, innovative technologies to improve the quality of products, reduce the cost of producing high-quality medicines, and demonstrate advances in project delivery.
The 2024 ISPE Pharma 4.0™ and Annex 1 Conference will be held 10–11 December in Rome, Italy, and virtually. Richard Denk and Line Lundsberg-Nielsen, the conference’s Executive Chairs, offer advice...
Pharmaceutical and biotechnology companies employ platform analytical procedures in the development stages of their synthetic and biological drug products and are beginning to leverage them for commercial products. This shift is supported by the acceptance of platform procedures in the recently adopted ICH Q2(R2) and ICH Q14. Six case studies are shared in this article to highlight how...
The pharmaceutical industry faces considerable challenges throughout the development, manufacturing, and supply of medicines, largely due to the intricate and divergent global regulatory landscape. The adoption of structured data standards and utilization of cloud-based platforms offer immense potential to overcome these challenges by facilitating faster and more efficient global...
On 13 March 2024, ISPE concluded the 2024 Aseptic Conference with a regulatory panel question and answer session. Attendees were invited to submit questions to representatives from the Austrian Agency for Health and Food Safety (AGES), US Food and Drug Administration (FDA), Regierungspraesidium Tübingen (RP Tübingen), World Health Organization (WHO), Therapeutic Goods Administration (TGA), and...
The pharmaceutical industry stands at the precipice of a revolution as emerging digital technologies provide new opportunities to boost productivity through continuous process improvements. The Pharma 4.0™ framework, an adaptation of the broader Industry 4.0 movement, aims to transform how drugs are produced and delivered.
With the approval of the first gene edited therapeutic in 2023, production of gene edited therapies is accelerating, introducing tough decisions for manufacturing development. Gene editing therapy production is complex, often involving multi-modality manufacturing operations in one facility to produce a single therapeutic. This article considers whether retrofitting an aging monoclonal...
Implementing advanced automation technologies is a strategic move that can amplify the positive outcomes of environmental, social, and governance (ESG) initiatives. By leveraging ESG initiatives, pharmaceutical companies can enhance their competitive edge and contribute positively to global sustainability efforts.
Cell and gene therapy (C>) 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...
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...
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...
Advanced therapy medicinal products (ATMPs) and cell and gene therapies (C>s) 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> manufacturing is using cell culture media. With thousands of ATMPs and C>s in clinical trial phases, the role of...
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...
Although traditional tank farm systems have long been the cornerstone of buffer preparation, they face challenges that have grown with the expansion of processing scale in the industry.
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...
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...
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,...
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.
Faced with global competition and shrinking margins, (bio)pharmaceutical manufacturers worldwide are urged to increase production efficiency by making better use of time and resources. This is in addition to addressing the unique challenges faced by pharmaceutical manufacturers such as a strictly regulated environment, heterogeneous equipment suppliers, and long adaptation times....
This Concept Paper proves that a standard model within OPC UA Alarms and Conditions (OPC UA Part 9) can be leveraged to realize Plug & Produce for exchanging pharmaceutical alarms and audit trails between OT manufacturing equipment and Orchestration Platforms or IT Services like EBR or Historian.
ISPE has announced the new 2024-2025 ISPE Affiliate and Chapter Council Chairs and Co-Chairs. ISPE Regional Affiliate Councils collaborate efficiently with the international ISPE organization and local regional peers to ensure optimal alignment and support for local success. ISPE currently has three regional affiliate councils including: Asia-Pacific Affiliate Council (APAC), European...
In 2020, CSL initiated a benchmarking activity with a small group of peer companies identified through ISPE to explore creation and maturation of Asset Management programs at each company. The initial sessions were a success, covering topics such as Asset Condition Evaluations and Asset Management Governance. CSL was keen to continue the conversations and gather more insights on certain...
At the 2024 ISPE Annual Meeting & Expo, in Orlando, Florida, this past October, ISPE proudly recognized Niranjan Kulkarni, PhD, with the prestigious Max Seales Yonker Award, as part of the 2024 International Honor Awards. Kulkarni was honored for his extraordinary volunteer service, leadership, and unwavering commitment to...
Advanced therapy medicinal products (ATMPs) are medicines based on genes, tissues, or cells. This class of products cannot be terminally sterilized and, in many cases, cannot be filtered and are manufactured by Aseptic processing. The increase in demand for these life-changing products has been fraught with technical and regulatory challenges as laboratory processes are scaled to commercial...
ISPE’s Pharma 4.0™ Baseline Guide authoring team received the prestigious Committee of the Year Award, as part of the 2024 ISPE International Honor Awards which were presented at this year’s 2024 ISPE Annual Meeting & Expo., The Committee of the Year Award recognized the Pharma 4.0™ Baseline Guide Authoring Team for their...
The pharmaceutical industry is undergoing a remarkable transformation, with advanced modalities like antibody-drug conjugates (ADCs) and radiopharmaceuticals driving the evolution of precision medicine. These innovations are not only redefining drug development but are also improving patient outcomes through targeted therapies, reduced side effects, and expanded treatment options. The...
On 16 October at the 2024 ISPE Annual Meeting & Expo in Orlando, Florida, USA, Emer Cooke, European Medicines Agency (EMA) Executive Director and chair of the International Coalition of Medicines...
In this blog post, Charlie Wakeham, Director of WakeUp to Quality and Chair of the ISPE GAMP® Global Steering Committee, shares a recap of the ISPE Australasia Digital Innovation Conference, which took place 24 – 25 September 2024.
All economic sectors, including life sciences, are undergoing a significant transformation driven by the increasing focus on integrating environmental, social, and governance (ESG) criteria into their strategies and activities. This shift is crucial as companies face growing pressures from stakeholders such as customers, regulators, suppliers, and employees to act responsibly and...
Designing a monoclonal antibody (mAbs) production facility presents a series of unique challenges, balancing regulatory compliance, efficiency, sustainability and flexibility. Through careful planning and design, companies can create production environments that meet growing demands while optimizing operational efficiency.
From Student to Leader: Paul Quizon’s Journey in Pharmaceutical Engineering
For students and recent graduates venturing into the pharmaceutical world, Paul Marvin Quizon’s story serves as an inspiring guide. From starting out as a graduate student at the University of the Philippines Manila, Quizon’s journey through academia, industry, and eventually to a leadership role within ISPE...
The pharmaceutical manufacturing landscape is becoming increasingly complex, especially with new regulations and technological advancements. One of the most significant challenges facing the industry today is the implementation of Annex 1, which focuses on the manufacture of sterile medicinal products. The 2024 ISPE Pharma 4.0™ and Annex 1 Conference...
The ISPE Sterile Products Processing Community of Practice (CoP) Steering Committee is thrilled to announce a valuable series of blog posts, where its committee members dive into the validation and use of essential equipment and processes that drive sterile processing in the pharmaceutical industry. Planned blog posts include:
As the pharmaceutical industry navigates the complexities of digital transformation, the concept of Pharma 4.0™ emerges as a pivotal framework for integrating advanced technologies into business processes. The upcoming 2024 ISPE Pharma 4.0™ and Annex 1 Conference,...
At the 2024 ISPE Annual Meeting & Expo held in Orlando, Florida, USA, in October, a panel of global regulators and industry professionals addressed harmonization and regulatory convergence, digitalization, particularly the use of artificial intelligence (AI), and supply chain resilience.
At the 2024 ISPE Annual Meeting & Expo, held 13-16 October in Orlando, Florida, USA Nina Cauchon, PhD, Director, Regulatory Affairs -- CMC, Amgen, led a session on the global adoption status and implementation strategies for recent International Council on Harmonization (ICH) guidelines
Theresa Mullin, PhD, Associate Director for Strategic Initiatives at the US Food and Drug Administration’s (US FDA) Center for Drug Evaluation and Research (CDER), opened the 2024 ISPE Meeting & Expo in...
The 2025 ISPE Aseptic Conference, taking place 17 – 18 March 2025 in Washington, D.C., USA, has always been one of the more future-focused technical conferences within ISPE. Originally called the ISPE Barrier...
In an era where technological advancements are reshaping every industry, the pharmaceutical sector is no exception. The 2024 ISPE Pharma 4.0™ and Annex 1 Conference is the gateway to understanding...
In an increasingly complex world, where the reliable delivery of power from point A to point B often depends on substantial construction and upgrade activities, the need for efficient project delivery has never been more critical. For manufacturers, completing pharma facility and process optimization projects quickly and cost-effectively can be challenging. As a result, many are exploring new...
The 2024 ISPE International Honor Awards were presented at the 2024 ISPE Annual Meeting & Expo in Orlando, Florida, in October. These awards provide the opportunity for the ISPE community to recognize and celebrate the dedicated professionals who volunteer countless hours to support ISPE and its mission.
This year’s 2024 ISPE Annual Meeting & Expo at Gaylord Palms in Orlando, Florida, USA was an inspiring experience, combining the energy of high-level industry discussions, networking opportunities, and moments of genuine connection. Despite the uncertainty brought on by Hurricane Milton, the conference went forward with an impressive spirit of resilience and adaptability. From insightful...
The future of manufacturing is not a battle between humans and machines. It is a collaboration that promises to redefine productivity and innovation. Industry 5.0 is poised to revolutionize how companies operate over the next decade, shifting the focus beyond mere automation and optimization to prioritizing the well-being of workers. This paradigm shift will transform workplaces, making them...
In September, ISPE released the second edition of their Good Practice Guide on Heating, Ventilation, and Air Conditioning (HVAC), which provides a detailed overview of HVAC considerations in the pharmaceutical industry. The second edition also reflects industry...
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In this point of view, Life Sciences greenfield builds, Capgemini’s life sciences manufacturing experts explores how greenfield builds—projects where facilities are constructed wholly or mostly from scratch—are helping organizations scale up production capacity, meet evolving regulatory requirements, and integrate pharma 4.0 initiatives. You’ll learn why greenfield sites are fast becoming a...
To date, there has been a reluctance for cell therapy manufacturing facilities to move away from Grade B manufacturing suites even with the implementation of closed processing or the use of isolator technology. Read this article, “Cell Therapy and Closed Process Manufacturing” by Stephen Judd to learn about the potential to effectively operate cell therapy facilities in lower grade cleanroom...
This paper focuses on the development of a diagnostic tool for predictive maintenance in industrial lyophilization systems. At the core of the system is an anomaly detection algorithm designed to identify abnormal patterns in operational data. Through its development, key diagnostic strategies have been identified to improve system reliability and early failure detection, ultimately aiming to...
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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