Innovation is an integral part of corporate strategy. Initiatives to facilitate innovation are continually developed and pursued. The 2022 ISPE Pharma 4.0™ Emerging Leader (EL) Hackathon was designed based on innovator needs and provided a hands-on blueprint manufacturing exercise. Over a period of two days and facilitated by 40 subject matter experts, coaches, and jury members, 50...
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.
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.
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...
Cell and gene therapy (C>) 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> when changes are made in their manufacturing processes.
Process capability is a fundamental concept for manufacturers. Pharmaceutical, biopharmaceutical, and medical device manufacturers leverage capability analysis along with other statistical quality control (SQC) techniques to enable timely supply of quality medicine to patients.
Since 2005, ISPE’s Facility of the Year Awards (FOYA) have recognized state-of-the-art projects utilizing new, innovative technologies to improve the quality of products, reduce the cost of producing high-quality...
The 2023 ISPE Biotechnology Conference opened on 26 June with a series of six keynote presentations on biotechnology and the development and manufacturing of advanced therapies. Tom Hartman, President and CEO of ISPE, introduced each of the keynote speakers.
Erich H. Bozenhardt is the Associate Director of Process Engineering in Regenerative Medicine Operations at United Therapeutics. Erich is an experienced bioprocess subject matter expert and internationally recognized authority in the areas of cell and gene therapy and bioprocessing. He has published more than 30 technical papers and is a frequent presenter at conferences.
Michelangelo Canzoneri, PhD, is a seasoned leader in the digital transformation space within the healthcare and life science industry currently serving as the Global Head of Group Smart Manufacturing at Merck KGaA, Darmstadt, Germany. In this pivotal role, he functions as the primary business interface across the life science, healthcare, and electronics sectors, steering the incubation,...
The field of advanced therapeutic medicinal products (ATMPs) has witnessed remarkable advancements in recent years. The Emerging Leaders (EL) community from the Belgium and Germany/Austria/Switzerland (D/A/CH) affiliates collaborated to develop an inclusive series of online seminars on ATMPs. This article gives highlights of the speakers, topics, and knowledge shared in ATMP online seminars...
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)...
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...
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...
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).
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.
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.
Pharmaceutical continuous manufacturing (CM) is recognized as a key process intensification technology, with investment expected to rise in the coming years and the focus shifting toward biologics. This article provides a review on the current state of CM implementation, offers insights into life cycle management and regulatory aspects, and explains how a data- and knowledge-centric approach...
In the interest of understanding the current state of continuous manufacturing for biologics and to facilitate the path toward adoption of these promising technologies, the United States Pharmacopeia (USP) and BioPhorum jointly sponsored a hybrid workshop. This article summarizes trends from the workshop and ponders next steps.
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
Funded by the European Commission from 2019, the Smart Pharmaceutical Manufacturing Project (SPuMoNI)1 harnesses the potential of state-of-the-art technologies for the pharmaceutical industry. This article discusses the main SPuMoNI accomplishments.
The global pandemic has demonstrated that now, more than ever, we need to work toward a global solution and prioritize the harmonization of technical requirements. Positive improvements have been observed in the acceptance and implementation of international standards by various regulatory agencies in Latin America. This article offers an overview of the chemistry, manufacturing, and controls...
The success of the biopharmaceutical industry and the expansion of manufacturing facilities, of both existing companies and newcomers, has put a strain on the number of temporary and permanent skilled workers needed to fill many positions in the Triangle.
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.
In today’s rapidly evolving landscape of manufacturing and quality assurance, the need for efficient, accurate, and compliant process validation has never been more critical. This guide will explore the evolution of process validation, the challenges and opportunities it presents, and the benefits of adopting a fully digital process-centric and data-driven approach. You will learn how to...
Temperature mapping is vital for preserving GxP product quality during manufacturing, storage, and distribution, especially for frozen products. Warehouses pose unique challenges for temperature mapping due to their size, study duration, and seasonal variations. However, the principles for temperature mapping remain consistent, whether for warehouses, chambers, refrigerators, or freezers.
At the 2023 ISPE Pharma 4.0™ & Annex 1 Conference in Barcelona, Spain and virtual, Track #6 will focus on Pharma 4.0 Enabling Technologies: Use Cases, Benefits, and...
At the 2023 ISPE Annual Meeting & Expo held in Las Vegas, NV, USA on 18 October 2023, a panel of global regulators answered questions submitted by attendees. The panel consisted of Paul Gustafson, PIC/S...
The ISPE 2023 Annual Meeting & Expo agenda is always packed with sessions offering pharmaceutical professionals opportunities to engage in industry-critical conversations. Several of ISPE's regulatory initiatives took center stage during the technical sessions in the Regulatory and Quality track at the
Just around the corner on 11-12 December, join us for a wealth of knowledge sharing, uniting industry experts to engage in discussions that unveil their insights and experiences through the 2023 ISPE Pharma 4.0™ and Annex 1 Conference.
On Wednesday, 18 October 2023, Dr. Celia Lourenco, Associate Assistant Deputy Minister of Health Canada's Health Products and Food branch, presented a keynote address titled “Advanced Manufacturing and Other Trends Supporting Access to Medicines for Patients” at the
In the intricate world of pharmaceuticals, where precision and safety are paramount, the marriage of innovation and sustainability is not just an aspiration—it's a necessity. Picture a scenario where the pursuit of product purity meets the responsibility to our planet. Welcome to the realm of "Eco-friendly Pharma: Sterilization and Sustainable Practices." As we embark on this exploration,...
There are opportunities abound to transform inefficient production processes from the supply chain through the entire manufacturing process using existing and new digital technologies to significantly enhance overall operational efficiencies. Discover the cutting-edge advancements in these essential business areas at the
The 2023 ISPE Annual Meeting and Expo was a memorable gathering. With a blend of approximately 2,500 in-person and virtual attendees, the event was a melting pot of pharmaceutical professionals....
As the 2024 ISPE Aseptic Conference Chair, Christa Myers, Sr. Fellow - Aseptic and Sterile Products, Vertical Market Leader at CRB gets asked many times: what’s next? What are the new trends? Can Aseptic manufacturing change be easier, more cost-effective, and manage risks better? What are the inspectors looking for? Why can this not be more clear? Let’s find those answers together.
In recent years pharmaceutical manufacturers have responded to increased demands for speed to market, rapid drug development, and increased manufacturing capacities with innovative approaches to adapt to quickly shifting global needs. The design and construction of pharmaceutical facilities has evolved as companies identify ways to prepare new and existing facilities for future needs and...
In August, ISPE unveiled a new Guidance Documents Portal that provides a significantly improved online user experience for ISPE’s full library of Guidance Documents.
We welcomed 2023 with high hopes and dreams of what Women in Pharma® could eventually be. As I prepare to conclude my time as the Chair of ISPE’s International Women in Pharma Steering Committee, I do so with immense gratitude.
This is my last column in Pharmaceutical Engineering®. It has been my real pleasure and an honor to serve as your International Board Chair. Thank you for your support and I, like you, look forward to another phenomenal year for ISPE in 2024.
As my first year on the ISPE Board of Directors draws to a close, I find myself reflecting on a year filled with unprecedented learning, growth, and valuable insights.
During the 2023 ISPE Membership Meeting and Awards Lunch, Michael Rutherford, the outgoing Chair of the 2022-2023 ISPE International Board of Directors, officially handed over the gavel to Scott Billman. As the new Chair for the 2023-2024 term, Scott Billman, Vice President, Engineering, Pharmaceutical Services, Thermo Fisher Scientific, will lead the board. Rutherford expressed his gratitude...
Over 2,600 attendees from across 30 countries and a remarkable 200 exhibitors convened at the 2023 ISPE Annual Meeting & Expo in Las Vegas, NV, USA.
Close to 500 people celebrated the 2023 Facility of the Year Award (FOYA) Winners at a reception and banquet Sunday night, 15 October, during the 2023 ISPE Annual Meeting & Expo at Mandalay Bay in Las Vegas, Nevada, USA. Genentech was announced as the 2023 FOYA Overall Winner.
A fireside chat featuring Robert M. Califf, MD, FDA’s 25th Commissioner of Food and Drugs, and Thomas B. Hartman, President and CEO of ISPE kicked off the 2023 ISPE Annual Meeting & Expo. The following is a brief summary of the session. Look for complete coverage of the interview in an upcoming issue of Pharmaceutical Engineering® magazine.
Through the ISPE Foundation Diversity Internship Program, junior undergraduate and graduate-level students are afforded an opportunity to immerse themselves in a summer of groundbreaking engineering projects at some of the most cutting-edge facilities. This experience not only fosters the development of invaluable technical skills, but also serves as a first chance for students to establish a...
As the 2023 ISPE Annual Meeting & Expo in Las Vegas, NV, USA draws near, anticipation builds among the 110 students and Emerging Leaders from around the world who will be in attendance. These exceptional...
The 2023 Facility of the Year Awards (FOYA) Honorable Mention recognizes projects that did not win a specific category but were clearly successful projects that overcame significant challenges in planning, execution, and delivery.
The 2023 Facility of the Year Award (FOYA) Pharma 4.0™ category recognizes companies that embody the Pharma 4.0™ concept. This includes not only implementing one or more technological innovations, but also demonstrating the ability to change their culture, processes, and people orienting them towards a 4.0 future....
The countdown has begun, and the anticipation is evident as we gear up for the highly anticipated 2023 ISPE Annual Meeting & Expo. As we look back at the successful conferences over the past years, this event promises to be nothing short of extraordinary, especially for students and Emerging Leaders.
Continued Process Verification (CPV) was introduced roughly 12 years ago by the FDA as a third stage in the guidance on the process validation life cycle. In addition to being a mandatory requirement for the pharmaceutical industry, CPV can also provide valuable information to improve the quality and consistency of products. There may be limited data available when a process is designed and...
A Comprehensive Guide to Temperature Mapping Your Ultra-Low Freezer: From Validation Planning to Summary Report Preparation
Pressures on pharmaceutical companies from regulators, governments, and competitors are forcing them to closely examine expenditure. But making cost savings while ensuring the standard of products remains high is problematic. Recent developments in process analytical technology have opened a door to reduced manufacturing costs without compromising product quality.
With the updated USP <797> and <800> regulations having come into effect on November 1st, 2023, pharmaceutical compounding faces new challenges in environmental control. These standards, vital to ensuring the safety and efficacy of compounded sterile preparations (CSPs), emphasize a risk-based approach to beyond-use dates and the criticality of precise environmental controls. For...
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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