After completing her doctoral degree at Oklahoma State University, Sarah Pope Miksinski received a fellowship at the National Institutes of Health. While working there, she realized that research was not the best career path for her.
Anil Mathai first heard about ISPE 30 years ago. “I attended Drexel University, where you are required to complete three cooperative education jobs. One of mine was for Rhône-Poulenc Rorer, Inc. in Collegeville, Pennsylvania. While I was there, I learned about validation and decided that I wanted to be in pharmaceuticals as a chemical engineer.”
In 2023, ISPE launched an expansive and significant initiative, Enabling Global Pharmaceutical Innovation: Delivering for Patients, to address the barriers to technological innovation in the pharmaceutical industry. The first activity of the initiative was to conduct a three-part survey of ISPE members to understand the circumstances and confirm the sources that create barriers to...
In each issue of Pharmaceutical Engineering®, we introduce a member of the ISPE staff who provides ISPE members with key information and services. Meet Wendy McGhee, Health Authority Outreach Manager in the Regulatory Operations group.
Each year, ISPE recognizes innovation in pharmaceutical facilities with the Facility of the Year Awards (FOYA). The 2024 FOYA submission finalists were announced at the 2024 ISPE Aseptic Conference in Vienna, Austria. Finalists for the 2024 awards highlight the continued progress and innovation at play in pharmaceutical manufacturing worldwide and across modalities. From projects tailored to...
The ISPE International Company of the Year award recognizes outstanding leadership and support provided by a company, as reflected by significant active participation in the Society’s committees, Communities of Practice (CoPs), programs, and activities, as well as its support of employee participation in ISPE. The winner for 2023, Roche, was announced at the 2023 ISPE Annual Meeting & Expo...
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.
This year, the ISPE Foundation made great strides in its mission of fueling global health equity by fostering access to knowledge and nurturing diverse talent.
Growing up on a farm, Allen Koester thought he would design farm equipment after earning his degree in mechanical engineering.
In 2019, ISPE released the Second Edition of the ISPE Baseline® Guide Vol 5: Commissioning and Qualification. This guide mirrors the industry’s evolution toward harmonizing with latest...
The new ISPE Good Practice Guide: Unique Identification of Glass Primary Containers in Pharmaceutical Fill and Finish Operations involved a cross-functional team of industry experts and professionals from parenteral/injectable medicine manufacturing. The team included industry competitors who worked together to establish a common approach. They provided a balanced, industrywide perspective on...
Rod Freeman started his career in the pharma-ceutical industry as an analytical chemist.
In April 2024, ISPE published the ISPE Guide: 503A Compounding - Regulatory Basis and Industry Good Practices for Pharmacies, adding to the growing body of knowledge ISPE is producing for the pharmaceutical compounding industry. Written by industry experts and reviewed by practitioners in the area, the guide provides an overview of relevant US Food and Drug Administration (FDA) regulations and...
The 2024 ISPE Annual Meeting & Expo will be held 13–16 October in Orlando, Florida, and virtually. David Churchward is the conference’s Executive Chair. He offers advice and shares what attendees can expect at the upcoming conference.
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.
The 2024 ISPE Facilities of the Future Conference opened on 29 January in San Francisco, California, with a series of six keynote presentations on innovations that are leading to advanced...
The 2024 ISPE Biotechnology Conference will be held 17–18 June in Boston, Massachusetts, and virtually. Phillip R. Smith is the conference’s Planning Chair. He shares what attendees can expect at the upcoming...
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.
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.
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...
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,...
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...
The ISPE Baseline® Guide Volume 5: Commissioning and Qualification (Second Edition) framework has gained significant attention, use, and adoption since the...
The new year is here and, with that, another International Women’s Day approaches! This incredibly important global movement, which takes place every 8 March, celebrates women’s achievements, raises awareness about discrimination, and advocates for accelerated equality and gender parity. ISPE’s Women in Pharma® community strives to accomplish all these goals through regional and international...
The 2023 ISPE Pharma 4.0™ and Annex 1 Conference was held in Barcelona, Spain, 11–12 December. Topics discussed included transforming operations, quality, and maintenance with Pharma 4.0™ principles...
Although he didn’t know it at the time, Nathan Temple’s service as a naval officer on the USS Asheville in Hawaii prepared him perfectly for a career in pharmaceutical engineering. “You learn so much, so quickly, on a submarine.”
ISPE has more than 21,000 members in more than 120 countries worldwide. As an ISPE member, you have access to this network, which can be exciting and overwhelming at the same time. Connecting at the local level unlocks the unique benefits that your local Affiliate or Chapter holds. Not only is this a career game changer, but it also opens doors of opportunity to experience your ISPE membership...
The impact people have on others’ lives is not always obvious. For many, the Advil mini pill might not seem like a big deal, but for people who have trouble swallowing pills, like cancer patients, the tiny pill has made a huge difference in their ability to manage pain. It’s projects like that, as well as treatments for bladder cancer and transthyretin amyloidosis, that Tammy Spain is most...
The newly released third edition of the ISPE Baseline® Guide: Volume 6 – Biopharmaceutical Manufacturing Facilities reinforces the concepts described in the second...
In a prerecorded interview shown during a keynote session at the 2023 ISPE Annual Meeting & Expo, Tom Hartman, ISPE President and CEO, and Dr. Robert M. Califf discussed several far-ranging and important topics. Califf, the US Food and Drug Administration (FDA) 25th Commissioner is a recognized expert in cardiovascular medicine, health outcomes research,...
Pharmaceutical Engineering® magazine is proud to announce that the 2022 Roger F. Sherwood Article of the Year is “Supporting Cell and Gene Therapy through...
On 19 October, the ISPE Foundation hosted its 2nd Annual Golf Tournament at Wildhorse Golf Course following this year’s Annual Meeting & Expo in Las Vegas.
The new ISPE Good Practice Guide: Process Gases, Second Edition presents recent advances in construction materials and updates on current good practices. It was revised based on the latest International Organization for Standardization in Pharmaceuticals, American Society for Testing and Materials, and American Society of Mechanical Engineers standards and is aligned with the latest regulatory...
As part of the 2023 ISPE Annual Meeting & Expo, the 2023–2024 ISPE International Board of Directors was introduced and the gavel was passed to a new Chair on 16 October 2023 during the 2023 ISPE Membership Meeting and Awards Lunch in Las Vegas,...
At the 2023 Facility of the Year Award (FOYA) Celebratory Banquet, ISPE announced the 2023 overall FOYA winner: Genentech’s Clinical Supply Center (CSC). In addition to winning the overall award, Genentech’s CSC project was recognized as the 2023 Pharma 4.0™ category winner for its bold objectives, innovation, and deep team alignment and...
Over 2,800 attendees from across 27 countries and 200 exhibitors gathered in Las Vegas, Nevada, in mid-October for the 2023 ISPE Annual Meeting & Expo. The conference kicked off with workshops and the Emerging Leaders Hackathon, where 17 teams competed to answer Roche/Genentech’s request for consultation on how to make single-use technology more...
An ISPE member since 1999, Charlie Wakeham has been active within the ISPE GAMP® community since 2001. A founding member of the GAMP UK Community of Practice (CoP), she is currently Chair of the GAMP Global CoP Steering Committee, one of the leaders of the GAMP Computer Software Assurance Special Interest Group (SIG), and a member of the ISPE Guidance Documents Committee. She has co-led or...
Lorrie Vuolo-Schuessler has been involved with ISPE and GAMP® projects since 2002. She has authored or co-led 11 ISPE GAMP-focused guidance documents, including ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) and the ISPE GAMP® Good Practice Guide: Enabling Innovation - Critical Thinking, Agile, IT Service Management. She is Immediate Past Chair of...
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.
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...
ISPE task teams created reports and a model to examine the challenges surrounding drug shortages, emergency preparedness, and the supply chain of active pharmaceutical ingredients (APIs). This article outlines these initiatives.
On 7 March 2023, ISPE concluded the 2023 ISPE Aseptic Conference with a regulatory panel question and answer session. Attendees were invited to submit questions to the FDA representatives. This article offers highlights from the discussion.
The Executive Chair for this year’s Annual Meeting offers advice and shares what attendees can expect at the upcoming conference in Las Vegas, Nevada.
Annex 1, the European Union’s revised GMP requirements for the manufacturing of sterile medicinal products, will take effect on 25 August 2023. In this panel, experts involved in industry’s commenting of the draft versions of Annex 1 offered background information on how the document was developed and answered questions on its implementation.
Hubertus Rehbaum, PhD, is Chair of the Process Analytical Technology & Lifecycle Control Strategy (PAT-LCS) Community of Practice (CoP) Steering Committee. He’s been a member of ISPE for eight years. He first became involved through the Germany/Austria/Switzerland (D/A/CH) Affiliate when he joined as an Emerging Leader and helped co-host events for the group, which he said helped him...
Catherine Hall is Chair of the Investigational Products, North America (IPNA) Community of Practice (CoP) Steering Committee and is one of the authors of the ISPE Good Practice Guide: Investigational Medicinal Product Reverse Logistics – Good Returns and Reconciliation Practices. She has been a member of ISPE for 18 years.
The pharmaceutical industry began applying the principles of continuous processing to the manufacture of oral solid dosage (OSD) forms in the mid-2000s. The consensus among experienced practitioners is that the continuous approach has numerous benefits. “Continuous manufacturing provides for a full range of product life cycle, from small volume clinical production to large volume commercial...
Christian Wölbeling has been a member of ISPE for 25 years. A founding member and current Chair of ISPE’s Pharma 4.0™ Community of Practice (CoP) Steering Committee, Christian has also been very involved with the GAMP® and Process Analytical Technology CoPs, as well as the ISPE Germany/Austria/Switzerland (D/A/CH) Affiliate.
The United Kingdom Emerging Leaders Awards program is an exciting initiative for ISPE because it recognizes and celebrates the efforts and contributions of young engineers in the United Kingdom pharmaceutical engineering and manufacturing sectors.
“Over the past 20 years, there have been an increasing number of highly potent materials handled within the pharma industry, to the point where most modern products require some degree of containment or other exposure control to maintain safety,” said guide team member Peter Marshall, AstraZeneca (retired).
The event, organized by and for recent graduates and students by the ISPE Emerging Leaders Community of Practice (CoP), offered high-quality presentations and interactive workshops where participants...
As Head of Merck’s Global Manufacturing Operations and one of the most senior operations leaders in Merck, Sanat is responsible for Merck’s worldwide manufacturing operations and product supply, supporting global sales revenue of over $55 billion.
Roujian “RJ” Zhang is Chair of ISPE’s new Quality Control (QC)/Analytical Community of Practice (CoP) Steering Committee. He is also Chief Quality Officer at Evive Biotech, responsible for all aspects of quality for the company, ensuring safety and efficacy, making critical quality decisions, and keeping the company up to date with new regulations. RJ became interested in the pharmaceutical...
Terry Jacobs is Chair of the Oral Solid Dosage (OSD) Community of Practice (CoP) Steering Committee. He is a recognized expert in the design of pharmaceutical, biotechnology, and corporate facilities and has completed projects for clients in the US, China, Mexico, and Saudi Arabia. He has lectured extensively on the planning and programming of laboratories and manufacturing and other...
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.
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...
ISPE’s new Advancing Pharmaceutical Quality (APQ) Guide: Process Performance and Product Quality Monitoring System (PPPQMS) focuses on the key aspects of maintaining and establishing an effective PPPQMS. An effective PPPQMS is crucial to establishing and maintaining a state of control. It enables continual improvement and is key to proactively identifying the need for product quality and...
The Commissioning and Qualification (C&Q) CoP was one of the first Communities of Practices to be established at ISPE. One of its founding members, Steve Wisniewski, Principal Consultant, CAI, said the Communities of Practice was formed in 2004 to identify and promote more efficient approaches that resulted in pharmaceutical facilities being fit for their intended purpose.
The 2022–2023 ISPE International Board took their places and the gavel passed to a new Chair during the 2022 ISPE Membership Meeting and Awards Lunch on 1 November during the 2022 ISPE Annual Meeting & Expo...
For nearly a century, production of water for injection (WFI) was universally accepted to be distillation-based. As emphasis on costs and environmental concerns has grown, pharmacopeias around the world have focused on the quality attributes of WFI to allow for consideration of other production technologies.
When the ISPE Baseline Guide Vol. 5, Commissioning & Qualification, 2 ed. was published in 2019, most of the attention was focused on the incorporation of quality risk...
Combination Products is one of ISPE’s newest Communities of Practice (CoPs). It started as a Special Interest Group to help people in the industry collaborate and learn from each other.
More than 400 attendees learned about the latest developments in biopharmaceuticals, cell and gene therapy, and ATMPs at the 2022 ISPE Biotechnology Conference, held 28–30 June in Boston, Massachusetts.
ISPE has more than 19,000 members from more than 129 countries, and many of them spend countless hours sharing their knowledge and connecting with others, helping ISPE to advance the educational and technical efficiency of all members.
Four teams of Emerging Leaders (ELs) represented one of four different company manufacturer types in the Emerging Leader Hackathon at the ISPE 2022 Europe Conference. This article provides some participants’ views of...
The Europe Hackathon for students and recent graduates was held 23–24 April as part of the activities during the 2022 ISPE Europe Annual Conference. This article provides an overview of the event and how it...
The members of the Sterile Products Processing (SPP) Community of Practice (CoP) Steering Committee are as diverse and varied as the topics they discuss. The Community of Practice is comprised of professionals from around...
Effective and timely management of change throughout the product life cycle enables quality improvement and is critical to patient safety, supply reliability, and operational effectiveness and efficiency. The ISPE Advancing Pharmaceutical Quality (APQ) Guide: Change Management System provides a quality management framework for assessing and advancing change management (CM) system maturity...
ISPE has more than 17 global Communities of Practice (CoPs) where members can connect with each other. Professional Communities of Practices for
Released in November 2021, the ISPE Guide: Advanced Therapy Medicinal Products (ATMPs)–Autologous Cell Therapy focuses on manufacturing facility development and design for autologous cell therapies for...
The lack of diversity in the pharmaceutical engineering industry is widely recognized. Less well understood is why change is so hard to achieve. From my years of work in this space, and through observation of ongoing efforts to embrace diversity in all forms, I have developed a hypothesis: Progress is stifled because we as a society wrongly believe diversity and inclusion efforts are...
The ISPE Annual Meeting & Expo is our signature event, uniting the pharmaceutical industry’s best and brightest to share their expertise, showcase their brands, and network. The 2021 ISPE Annual Meeting ...
Eamon Judge, the 2020 recipient of the Max Seales Yonker Member of the Year award, exemplifies the values behind the award: service to the industry and inspiring ISPE members to volunteer.
Since the first edition of the ISPE Good Practice Guide: Good Engineering Practice (GEP) was published in 2008, the pharmaceutical industry and regulators developed industry standards, best practices, and regulatory guidance around topics that relate to Good Engineering Practice, culminating in particular in the ISPE Baseline Guide: Commissioning & Qualification (Second Edition). The...
ISPE’s Carolina-South Atlantic (CaSA) Chapter serves members from six different states in the US: North and South Carolina, Tennessee, Alabama, Georgia, and Florida, each with their own unique contributions to the pharmaceutical industry.
The traditional passing of the gavel took place in person at the 2021 ISPE Annual Meeting & Expo on 2 November. The
The second guide in ISPE’s Advancing Pharmaceutical Quality (APQ) series provides a systematic and proactive approach to quantitatively assessing and advancing leadership systems by evaluating the management responsibilities highlighted in ICH Q10 as well as other key leadership components.
Japan’s pharmaceutical market is one of the world’s largest and the ISPE Japan Affiliate is helping its members stay connected and current in the ever-changing pharmaceutical industry.
The ISPE Foundation Diversity Internship Program has received strong response from applicants and has launched a new partnership.
The pharmaceutical industry in Spain and Portugal is growing, and the ISPE Iberia Affiliate—which has merged the Spain and Portugal Affiliates to take advantage of synergies between the two Affiliates—is working to train and support this expanding market.
Maintenance can impact both the quality of products and the compliance of pharmaceutical processes, and maintenance programs have long been recognized as critical to the success of the operations they support.
ISPE Emerging Leaders (ELs) held the first fully virtual International Hackathon in February. Fifty-one participants from over 22 countries encountered real-life challenges with working remotely and across time zones. Innovation...
The ISPE Aseptic Conference will celebrate its 30th year with the virtual conference on 15–17 March. The conference has been setting the pace for the evolution of sterile manufacturing processes and technologies in...
Equipment reliability helps reduce and manage the risk of failures in equipment, providing focus on availability, fitness for purpose, and cost. Reliable equipment improves the likelihood of achieving reliable manufacturing operations, which improves the supply of critical therapies to patients worldwide.
The 2020–2021 ISPE International Board of Directors began their term at the Member Meeting on 5 November during the
Data Integrity by Design is the concept that data integrity must be incorporated from the initial planning of a business process through to the implementation, operation, and retirement of computerized systems supporting that business process.
To continue meeting the professional needs of ISPE members and with the global increase of virtual events due to COVID, ISPE has expanded its webinar offerings on topics important to ISPE members and industry sponsors.
The ISPE D/A/CH affiliate Is a Leader in Many Respects, from Its Ever-Increasing Size to the Invaluable Engagement of Its Members, Who Contribute to Ispe’s Growth around the World. Grouping Together Europe’s German-Speaking Countries—Germany (D), Austria (a), and Switzerland (Ch)—It Is Currently the Second Largest Ispe...
In honor of the 40th birthday of ISPE and Pharmaceutical Engineering®, we looked back to 2010 to see what technology-focused articles were published in the magazine. Here are just a few:
In March 2020, the ISPE Eurasian Economic Union (EAEU) Affiliate was officially established. This event was a significant step along the journey to integrate members from Eurasian Economic Union nations into the international pharmaceutical community, as well as another sign of progress in the development of a harmonized scientific,...
ISPE has published a new Good Practice Guide: Critical Utilities GMP Compliance—How to Be Compliant and Ready to Prove It. Written and reviewed by...
ISPE has a new special interest group (SIG) to work on IT cybersecurity. The Special Interest Group was formed under GAMP®. A conversation with Jason Young of Silver Bullet Security, who heads the new group, provides details about the Special Interest Group.
Pharmaceutical Engineering® has launched another new section on the Pharmaceutical Engineering Online site: Online Exclusives. Pharmaceutical Engineering Online Exclusives are articles published exclusively on the Pharmaceutical Engineering website. This new feature expands the...
As one of the larger and older ISPE Chapters, the ISPE Delaware Valley Chapter (DVC) is admired by other Chapters and Affiliates around the world.
The 2019 ISPE Max Seales Yonker Member of the Year Award was presented to Charlie Wakeham, a data integrity and compliance specialist based in Sydney, Australia, who has played an instrumental role in the development of GAMP®.
Before traveling to the 2019 ISPE Annual Meeting & Expo in Las Vegas, the ISPE Japan Affiliate held its annual phar-maceutical plant tour over five days (21–25 October), visiting two plants in Los...
The 2019 ISPE Europe Pharma 4.0™ Conference held in Manchester, UK, on 20–21 November 2019 was attended by 300 participants, all of whom contributed to the growing momentum for
Since its inception at the ISPE 2016 Annual Meeting & Expo, Women in Pharma® (WIP) has been rapidly growing. In the US and Europe, the society has held numerous Women in Pharma® events at local Affiliates, Chapters, and...
ISPE’s online site for Pharmaceutical Engineering was launched a little over one year ago, in November 2018. Here are some statistics about the site’s success during its first year.
ISPE’s newest Special Interest Group (SIG) will work on the emerging areas of artificial intelligence (AI) and machine learning (ML). The Artificial...
