While financial investment in novel therapies provides patients with new treatment options and improved quality of care, the pharmaceutical industry also recognizes its responsibility to transition toward more sustainable development, manufacturing, and stewardship of medicines throughout their life cycle.
To enable changes across the pharmaceutical industry, sustainability should be included alongside quality, efficacy, and safety when assessing medicines. This article reviews two case studies that cover sustainable pack types and extension of shelf life. With the drive to manage unmet medical need through acceleration of drug development programs, postapproval sustainability variations will...
Many emerging tools and technologies support the environmental sustainability of the pharmaceutical industry. In facility design, solutions are derived through science-based analyses of environmental impacts from the materials, processes, services, and architecture. From greener energy sources to a reduction in the type and amount of emissions, we are seeing improvement in this sector’s...
The imperative for global action to tackle climate change is clear and the pharmaceutical industry has a key role to play. Governments have entered into international commitments to reduce climate impact (carbon emissions) and protect nature (water, land, air, and biodiversity) with policy frameworks established to facilitate and drive progress against agreed targets.1
The expected FDA approval for a Treprostinil dry powder inhaler revealed a need for the manufacturer to expand its warehousing and logistics capabilities to support its growing operations. The company’s senior leadership wanted to ensure this expansion came with as minimal an impact on the environment as possible, so a key priority was to provide a net zero energy facility. With a vision for...
Computational fluid dynamics (CFD) can reduce or eliminate the uncertainty associated with a cleanroom facility as the planned design can be simulated to predict performance to a high degree of accuracy. This article discusses the use of CFD for the purpose of predicting and optimizing the performance of a cleanroom facility in terms of steady-state airborne particulate levels and for...
Cultural excellence is the expressed and implied ways in which an organization operates. Excellence in organizational culture is essential for delivering robust and sustained quality performance and ensuring patient-focused outcomes. ISPE’s new Advancing Pharmaceutical Quality (APQ) Guide: Cultural Excellence provides a quality management framework for assessing and advancing an organization’s...
With this issue, Pharmaceutical Engineering® launches a new feature in P+E: profiles of Communities of Practice (CoP) leaders. These leaders are central to the success of ISPE’s CoPs, which spearhead the generation of ISPE’s gold standard content, including Good Practice Guides, Pharmaceutical Engineering articles, conference presentations, and training programs.
With this issue, Pharmaceutical Engineering® launches a new feature in P+E: profiles of Communities of Practice (CoP) leaders. These leaders are central to the success of ISPE’s CoPs, which spearhead the generation of ISPE’s gold standard content, including Good Practice Guides, Pharmaceutical Engineering articles, conference presentations, and training programs.
Recent advances in artificial intelligence (AI) have led to its widespread industrial adoption, with machine learning (ML) algorithms demonstrating advances in performance in a wide range of tasks. However, this comes with an ever-increasing complexity of the algorithms used, rendering such systems more difficult to explain.1
ISPE’s GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) (GAMP® 5 Guide, 2nd Edition) maintains the principles and framework of the first edition and updates their application in the modern world, including the increased importance of service providers, evolving approaches to software development, and expanded use of software tools and...
In this article, potential Pharma 4.0™ technological solutions that can enhance continuous process verification (CPV) 4.0 are discussed. The necessary paradigm shift will allow companies to predict deviations more accurately, perform root cause analysis (RCA), ensure data integrity and GxP compliance, and ultimately be more competitive in a highly regulated industry.
Cell and gene therapies (C>) have unique needs in manufacturing suites that differ from those for classic product biopharmaceuticals. Facilities must be created with flexibility in mind, able to run multiple products and production types to remain viable.
Resounding clinical successes and maturation of extensive therapeutic pipelines have catapulted oligonucleotides from a fringe modality to therapeutic relevance in just a few short years. Oligonucleotides are a cornerstone of a burgeoning class of drugs classified as nucleic acid therapeutics. These therapies interact with DNA and RNA targets rather than traditional protein therapeutic...
Digital health is transforming the health care landscape through new technologies and platforms in patient care management, conducting of clinical trials, patient data collection, and the diagnosis and treatment of disease. Emerging digital health technologies (DHTs) may improve the quality of life for patients with chronic and debilitating diseases and provide novel health care solutions for...
A reliable supply of raw materials is critical to maintain a robust supply chain to serve patients globally. With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. Therefore, there is an increasing need to implement a harmonized regulatory infrastructure that is both flexible and predictable to provide more...
Postapproval change management of pharmaceuticals is an essential part of life-cycle management but is associated with regulatory challenges. Incorporating concepts and tools from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q12 guideline, combined with structured content and data management (SCDM) and a cloud-based data exchange...
Although data and knowledge are both stand-alone disciplines that need to be systematically managed, they also must have a connection. Understanding the relationship between data and knowledge management processes and how people are leveraging advances like Pharma 4.0™ combined with these processes enables quality data transition to knowledge that can help pharmaceutical companies. The authors...
As the pharmaceutical industry continues to grow and evolve, a significant contributor to innovation and evolution is mergers and acquisitions (M&A). M&A can enable academic researchers and small companies to fund and commercialize innovative products. In addition, M&A can help larger organizations secure new and complementary technology and products. In the pharmaceutical...
As the industry experiences significant changes to the way we do business, knowledge capture and sharing are more important now than ever before. The maturing digitalization of the biopharma industry’s business and processes is creating an increasingly data- and information-rich environment that requires more effective mechanisms for sharing data and information. The Knowledge Management team...
On 26 January 2022, representatives of the author team for the ISPE Good Practice Guide: Knowledge Management in the Pharmaceutical Industry held a webinar to provide an...
In a recent advanced therapy medicinal products (ATMPs) innovator survey, two-thirds of respondents reported that they are developing multiple drug platforms.1 Without a guarantee of commercial success for any single product, many...
The life cycle approach to process validation stresses the need for continued monitoring of process performance to ensure that the manufacturing process remains stable and predictable, i.e., in a state of control. This life cycle stage is known as continued process verification (CPV) or ongoing process verification (OPV).1
Water is a key component in the pharmaceutical industry. It functions as an ingredient, a cleaning agent, a reagent, a solvent and a product, throughout the drug discovery process, from the initial identification of potential drug targets, all the way to the manufacture and quality control of the final product.
Cleaning and microbial contamination control are critical focus areas in pharmaceutical and medical device industries. Robust cleaning and disinfection programs are needed to meet the required cleanroom microbial grades, to prevent cross contamination and subsequent microbial contamination of products. This white paper reviews the latest cleaning and disinfection updates in the newly revised...
The advantages that come with a fully digitalized plant for manufacturing biopharmaceuticals are well documented and showcased throughout the biopharmaceutical industry and will be a featured topic during the 2023...
When working with the common technical dossier (CTD), the structure of Module 2 “follows the scope and outline of the Body of Data in Module 3,”1
We are The Culture Club, a self-formed cross-CoP group of individuals who came together to discuss challenges encountered as we transition quality and validation into the digital world and identify ways to influence cultural changes needed within our industry to better enable innovation. As we are not all from the same CoP, we first needed to establish a way to connect and collaborate with all...
On 17 December 2022, more than 100 people from all over the world gathered online for the 2022 ISPE China Pharmaceutical Supply Chain Summit. With multiple geopolitical and pandemic related challenges in recent years, having a robust supply chain has increasingly become a strategic advantage for the pharmaceutical industry. The pharmaceutical supply chain runs through the entire process of new...
In the iSpeak Blog posting on 14 March 2023, the first part of this blog series introduced the results of a survey that was conducted of users of single-use assemblies. The focus...
Members of the paperless validation subcommittee created this blog post to discuss and recommend “true copy verification practices” for the use of Paperless validation systems to satisfy the current guidance for data integrity, and to discuss how to fully eliminate paper from various validation processes without impacting compliance to these current regulations.
The Biopharmaceutical industry continues to grow and deliver life-changing medicines to patients as evidenced by the number of drug approvals by the FDA year after year. In 2022 alone CDER approved 37 novel drugs, either as new molecular entities (NMEs) under New Drug Applications (NDAs) or as new therapeutic biological products under Biologics License Applications (BLAs). This has all been...
The 2022 ISPE Pharma 4.0™ Emerging Leader Hackathon event was organized by the ISPE Emerging Leaders DACH Affiliate in collaboration with the ISPE Pharma 4.0™ Community of Practice (CoP) Plug and Produce Subcommittee. The goal was to bring together students and young professionals from different fields of study and countries together to explore the emerging challenges and opportunities in...
The lifecycle of interfaces is of crucial importance for the interoperability of systems from different technical and organizational areas within or between companies.
Interfaces are the integration points of connected systems for the transmission of master or transaction data including status updates. Interfaces are typically parts of data streams or data hierarchies, e.g., Lab...
The pharmaceutical industry is rapidly evolving. The major trends in the recent years are (1) fully automated production such as continuous manufacturing and (2) the adoption of digitalized processes for paperless production. Both approaches have significant implications for Annex 1 compliance and the role of Contract Manufacturing Organizations (CMOs) in production facilitating these...
Users Perspective on End of Life Management for Single-Use Products used in Bioproduction
ISPE invites Emerging Leaders and Students from all over the globe to join us at this unique virtual event to explore the ISPE Communities of Practice (CoPs) and meet with the leaders of the CoP Steering Committees. This provides an opportunity to engage with industry leaders, learn about the various CoPs, and find out how you as an Emerging Leader or Student can get more involved.
Arriving in the United States at the age of 17 to pursue my dreams was one of the greatest challenges of my life. It was through this experience that I learned the importance of challenging my perspective. This was made possible through my involvement with ISPE, and four years later, I’m proud to announce the launch of Mentor ISPE.
Pharmaceutical and biotech portfolios continue to transition from high volume blockbusters to a diversified set of lower volume, targeted therapeutics. At the same time, many companies are pursuing localized manufacturing to adjust to supply chain challenges and to improve access to medicine. The industry must also address increased pricing pressure due to inflation and government policies....
GAMP® 5 (Second Edition) was published on 29th July 2022 and was presented and discussed at the 2023 ISPE Annual Meeting and at several local...
Sustainability is a buzzword that has been tossed back and forth across industries for decades. For a while, it was seen as something that consumers didn’t really care about, but now the reality is different. According to a 2022 study,1
2023 continues to move right along—the first quarter is almost over. I remain very optimistic about this year as ISPE International, with support from the International Board, continues to make progress on our 2023 objectives and the 2023—2025 ISPE Strategic Plan.
When nominating Martin (Marty) Lipa, Executive Director, Knowledge Management, Merck & Co. Inc., for the 2022 Max Seales Yonker Member of the Year Award, Anne Greene, Professor, Technological University Dublin, said, “Arguably the last year has been pivotal for the practice of knowledge management (KM) in the pharmaceutical industry based on new knowledge management frameworks and guidance...
Arriving in the United States at the age of 17 to pursue my dreams was one of the greatest challenges of my life. It was through this experience that I learned the importance of challenging my perspective. This was made possible through my involvement with ISPE, and four years later, I’m proud to announce the launch of Mentor ISPE.
Here’s How Our Members Intend on Making It a Reality…
Each International Women’s Day, the world comes together to celebrate the social, economic, cultural, and political achievements of women, calling for accelerated equality across borders. International Women’s Day has taken place for over a century, with the first taking place in 1911 and having the support of over a million...
Just off the heels of ISPE’s Facilities of the Future Conference, which took place this past February, ISPE’s Women in Pharma continues to leverage its momentum to amplify the group’s mission to create a more equitable pharmaceutical industry on a grand scale.
The 2023 Facilities of the Future Conference Women in Pharma panel welcomed a full room. Seen from left to right: Carolina Serrano (moderator), Kerren Bergman, Vivianne Arencibia and Jessica Ballinger
The second day of the 2023 ISPE Facilities of the Future Conference in North Bethesda, Maryland, included keynotes addressing various facets of the industry and their impact on future facilities planning and development. Key among these included a presentation by the director of FDA’s CBER on cell and gene therapy manufacturing and a range of considerations behind new facility planning from a...
The updated EU GMP Annex 1 Revision: Manufacture of Sterile Medicinal Products released in August 2022 introduced changes which require more stringent sterile manufacturing processes, including implementing a contamination control strategy and new technology to reduce the risk of contamination. Regulators discussed those changes and how they impact manufacturing practices during panel...
ISPE is launching a new program, Enabling Global Pharma Innovation: Delivering for Patients in support of many regulatory agencies’ ambitions to promote introduction of innovative pharmaceutical manufacturing. It is incumbent for industry to modernize and innovate pharmaceutical manufacturing to improve efficiency and increase confidence in quality assurance for the benefit of...
Pharmacopeial requirements for water purity are more stringent than ever. Initiatives such as Process Analytical Technology (PAT), and Quality by Design, challenge life science companies to achieve true process control, emphasizing the importance of real-time measurement.
From Abciximab to Zolbetuximab – the list of therapeutic monoclonal antibodies (mAbs) is long and constantly growing. The need for reliable, scalable manufacturing systems is growing along with it. ZETA has been a leader in the development of technical solutions for liquid aseptic production systems for years. A track record of successfully...
G-CON is a global biocapacity provider enabling the speed and delivery of manufacturing infrastructure for biopharmaceutical products. G-CON delivers complete, prefabricated biopharmaceutical cleanroom environments for uses ranging from small labs to commercial scale production platforms. Through standardization, quality and “built-off-site”...
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.
Are you a subject-matter expert in the global pharmaceutical industry? Are you brimming with knowledge about the latest technical developments or regulatory initiatives? Have you found an innovative solution to a real-world challenge?
Contribute your knowledge and experience to the always-evolving pharmaceutical industry!
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