Special Reports

2020 ISPE Annual Meeting & Expo: Driving the Future of Pharma
Special Reports
2020 ISPE Annual Meeting & Expo: Driving the Future of Pharma
The 2020 ISPE Annual Meeting & Expo will be ISPE’s first completely virtual Annual Meeting. As always, there will be great learning and networking opportunities—in fact, the digital format offers greater flexibility for attendees.
FOYA Category Winners & Honorable Mentions for 2020
Special Reports
FOYA Category Winners & Honorable Mentions for 2020: Examples of Excellence
Each year, ISPE celebrates innovations and advances in pharmaceutical manufacturing technology with its Facility of the Year Awards (FOYA) program. This year, we added a new category, Social Impact, to recognize companies that developed new standards and practices to prevent drug shortages and...
Special Section: 2020 ISPE Annual Meeting & Expo
Special Reports
Special Section: 2020 ISPE Annual Meeting & Expo
2020 ISPE Annual Meeting & Expo: Driving the Future of Pharma The 2020 ISPE Annual Meeting & Expo will be ISPE’s first completely virtual Annual Meeting. As always, there will be great learning and networking opportunities—in fact, the digital...
Special Report COVID-19 Impact
Special Reports
Special Report COVID-19 Impact
Pharmaceutical Engineering® COVID-19 Impact Survey: How the Industry is Responding to the Pandemic In late April and early May, Pharmaceutical Engineering surveyed over 50 ISPE members who hold leadership positions within the Society about the...
How Vaccines Are Developed
Special Reports
How Vaccines Are Developed
Vaccine development is an intricate undertaking, which may involve numerous challenges from the initial process of identifying an antigen to the final steps of delivering and administering the licensed product. The COVID-19 pandemic has put a spotlight on the science of vaccine development. As the...
Pandemic Preparedness & Business Continuity
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Pandemic Preparedness & Business Continuity
This article updates a 2006 Pharmaceutical Engineering® Online Exclusive article titled “Avian Flu—Is My Company Prepared?” by Wendy Haines and Martin Rock.Haines, W., and M. Rock. “Avian Flu—Is My Company Prepared?” Pharmaceutical Engineering 26, no. 6 (November-December 2006): Online Exclusive....
Engage with Health Authorities to Mitigate & Prevent Drug Shortages
Special Reports
Engage with Health Authorities to Mitigate & Prevent Drug Shortages
When faced with large-scale disruptive events such as the COVID-19 pandemic, the emergency and business continuity plans of drug manufacturers and event-specific actions of health authorities may not always be sufficient to prevent shortages of critical medical products. However, early, transparent...
Special Report: 2019 ISPE Annual Meeting & Expo
Special Reports
Special Report: 2019 ISPE Annual Meeting & Expo
Global Regulatory Town Hall: Answers to Key Questions The 2019 ISPE Annual Meeting & Expo plenary featured a global regulatory town hall addressing a wide range of information about trends in regulations and other developments in the...
Commander Emily Thakur, CDER/FDA (left) and Rapti Madurawe, CDER/FDA.
Special Reports
ISPE Global Regulatory Town Hall: Answers to Key Questions
The 2019 ISPE Annual Meeting & Expo plenary featured a global regulatory town hall addressing a wide range of information about trends in regulations and other developments in the pharmaceutical industry. The town hall format offered attendees the chance to ask a panel of regulators about issues...
Members of Team Mini Xoom at work on their solution.
Special Reports
ISPE Global Hackathon 2019: Report from the Winning Team
The first ISPE Global Hackathon was held at the 2019 ISPE Annual Meeting & Expo with six teams and 36 participants, including 19 undergraduate students, 11 graduate students, and 6 Young Professionals (YPs). Three members of the winning team, Team 4, named Team Mini Xoom, shared insights about...
Special Section: 2019 Ispe Annual Meeting & Expo
Special Reports
Special Section: 2019 ISPE Annual Meeting & Expo
This special section looks at what’s coming up at the 2019 ISPE Annual Meeting. It also features the voices of first-year Travel Grant recipients who attended last year’s Annual Meeting courtesy of the ISPE Foundation and offers a look at the 2019 Facility of the Year Award (FOYA) category winners...
FOYA Category Winners and Honorable Mentions for 2019: Best of the Best
Special Reports
FOYA Category Winners and Honorable Mentions for 2019: Best of the Best
Each year, ISPE celebrates innovations and advances in pharmaceutical manufacturing technology with its Facility of the Year Awards (FOYA) program. This year’s nine category winners and honorable mentions range from industry giants with hundreds of years of history to relatively new enterprises....
ISPE Foundation® Student Travel Grant Recipients Speak Out
Special Reports
ISPE Foundation Student Travel Grant Recipients Speak Out
The ISPE Foundation® awarded 14 Student Travel Grants to bring 14 students to the 2018 ISPE Annual Meeting & Expo. Investing in the next generation of pharmaceutical engineers is a goal of the Foundation, which was formed in 2018.
2019 ISPE Annual Meeting & Expo: Modernize, Globalize, and Transform
Special Reports
2019 ISPE Annual Meeting & Expo: Modernize, Globalize, and Transform
The 2019 ISPE Annual Meeting & Expo will be held 27–30 October in Las Vegas, Nevada. The theme is “Modernize. Globalize. Transform.” Michael L. Rutherford, Program Committee Chair and Board Ambassador for ISPE, and Executive Director for Computer Systems Quality and Data Integrity at Syneos Health,...
Judging the teams’ spaghetti towers during the icebreaker activity.
Special Reports
Networking & Learning at ISPE Young Professionals HackaThon
The ISPE Young Professionals Hackathon, which has become an annual event run in conjunction with the ISPE Europe Annual Conference, brings together some of the brightest, most inquisitive young engineers from across Europe for a two-day networking and learning event.
Digitization, Technologies, and More at 2019 ISPE Europe Annual Conference
Special Reports
Digitization, Technologies, and More at 2019 ISPE Europe Annual Conference
More than 800 attendees met in Dublin, Ireland, on 1–4 April for the 2019 ISPE Europe Annual Conference—a new record attendance for this conference! Participants at ISPE’s sixth Europe conference learned about how manufacturers, key suppliers, functional peer groups, and regulators expect the...
2019 ISPE Europe Annual Conference Special Report
Special Reports
2019 ISPE Europe Annual Conference Special Report
Digitization, Technologies, and More at 2019 ISPE Europe Annual Conference More than 800 attendees met in Dublin, Ireland, on 1–4 April for the 2019 ISPE Europe Annual Conference—a new record attendance for this conference! Participants at ISPE’s...
CAPA Maturity
Special Reports
CAPA Maturity
The ISPE Advancing Pharmaceutical Quality (APQ) team is developing a framework by which a company can assess its maturity in relation to quality culture, operational excellence, and ICH Q10 elements, using the CAPA system as the focus of the pilot.
Special Report 2018 Europe Annual Conference
Special Reports
Special Report 2018 Europe Annual Conference
Sold-Out Europe Annual Conference Draws Record Attendance In March 2018, more than 640 attendees met in Rome for the 2018 Europe Annual Conference.The record attendance and roster of 70 speakers made it the largest ISPE Europe meeting to date. Sessions...
Pharma 4.0™: Hype or Reality?
Special Reports
Pharma 4.0™: Hype or Reality?
The smart factory, the factory of the future, the Industrial Internet of Things (IIoT), and Industry 4.0. These are buzzwords that populate a new manufacturing world triggered by digitalization. “Pharma 4.0™” is a holistic operating model for...
Serialization: A Global Transformation
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Special Report: Serialization - A Global Transformation
  Deadlines Are Looming Whether serialization deadlines have arrived or are imminently approaching, smaller companies along pharmaceutical supply chains are scrambling to prepare—and for many, it’s a problem. Making a Serialization Program...
Article
Special Reports
Serialization Deadlines Are Looming
Whether serialization deadlines have arrived or are imminently approaching, smaller companies along pharmaceutical supply chains are scrambling to prepare—and for many, it’s a problem. TraceLink, a track-and-trace network for pharmaceuticals, estimates...
ISPE Pharmaceutical Engineering
Special Reports
Lessons Learned from the Sarbanes-Oxley Act
Fifteen years ago, corporations embarked on a journey toward SOX compliance; along the way they have learned a tremendous amount about data integrity as it relates to financial systems. Those lessons learned are directly applicable to many of the data-integrity challenges facing the pharmaceutical...
ISPE Pharmaceutical Engineering
Special Reports
Prepare for Regulatory Audits with Your Supplier
Data integrity continues to be a very hot topic for both regulators and the pharmaceutical industry. With the increased observations about data integrity in laboratories, could it be that analysts have changed how they do science in the laboratory? Are...
Data Integrity & Biopharmaceutical Manufacturing
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Special Report: Data Integrity & Biopharmaceutical Manufacturing
Before the advent of integrated computer systems, LIMs, HMI interfaces, comprehensive software, CGMP, BAS, process control systems, PAT, and the use of statistics, manual record keeping was fraught with errors—most of them unintentional. This led to...
Special Report Quality Metric
Special Reports
Special Report Quality Metrics
ISPE Proposes an Advancing Pharmaceutical Quality Program The ISPE Quality Metrics team has proposed an industry-led approach to advance pharmaceutical quality beyond the submission of data for three harmonized, reportable metrics: the Advancing...
Article
Special Reports
China & India Target Future GMP Manufacturing
China’s biological pipeline may take the lead China and India have demonstrated their capability in good manufacturing practice (GMP) manufacture of small-molecule drugs for decades. But...
Biopharma's Portfolio Drives New Technology
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Biopharma's Portfolio Drives New Technology
The portfolio sold by today’s global biopharmaceutical industry is fundamentally different than it was even a decade ago. This shift is a reflection of today’s global market, which features greater competition, more treatments for orphan diseases, an...
Engineer's Role in the Biopharmaceutical Supply Chain
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Engineer's Role in the Biopharmaceutical Supply Chain
As the industry evolves in its quest to increase quality, productivity, efficiency, and safety, engineers must be equipped with skills that enable them to meet new and challenging demands. This first in a two-part series focused on biopharmaceutical manufacturing explores a few of the exciting...
Proof of Closure: Life Cycle of Closed Systems
Special Reports
Proof of Closure: Life Cycle of Closed Systems
This article was developed by members of the ISPE Biotechnology Community of Practice. The views and opinions are those of the authors and do not necessarily reflect the official policy or position of Hargrove Life Sciences, M+W, Novartis, Sandoz, Takeda, or any of their officers.
2016 ISPE Continuous Manufacturing Conference Summary
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2016 ISPE Continuous Manufacturing Conference Summary
This paper discusses the findings and outcome of the ISPE Continuous Manufacturing Conference held 20–21 April 2016 in Baltimore, Maryland. While the ideas captured below reflect presentations and discussions both during the main conference and in breakout sessions, they are not necessarily the...
Understanding Cleanliness Classifications for Life Science Facilities
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Understanding Cleanliness Classifications for Life Science Facilities
In recent years we have observed misunderstanding and confusion over correlation between the 2004 US Food and Drug Administration (FDA) environmental cleanliness requirements for sterile product manufacture 1 and those of the European Medicines Agency...
Building A Stronger Industry
Special Reports
Special Report: Building A Stronger Industry
Sustainability And The Life Sciences Industry Sustainability, also referred to as sustainable development, has, in the pharmaceutical industry, been, in the main, in the background, especially when it comes to facilities and engineering. In the few...
Sustainability & the Life Sciences Industry
Special Reports
Sustainability & the Life Sciences Industry
Sustainability, also referred to as sustainable development, has, in the pharmaceutical industry, been, in the main, in the background, especially when it comes to facilities and engineering. In the few cases where dedicated individuals or companies have...
Why is 90 fpm Considered Standard for Cleanroom Airflow
Special Reports
Why is 90 FPM Considered Standard for Cleanroom Airflow?
In 1961, while working at Sandia Laboratory in New Mexico, Willis Whitfield and his colleagues developed the world’s first cleanroom and clean benches. These developments were instrumental for the electronics, aerospace, and later, pharmaceutical...
Young Professional Voices
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Special Report: Young Professional Voices
ISPE knows that the future of the pharmaceutical industry lies with its youth—and to prove it, we’ve contacted five former contestants to see how the competition affected their careers.
graphic of world map
Special Reports
International Student Poster Winners: 2000–2016
North and South America Argentina Affiliate Brazil Affiliate Canada Affiliate (11 winners) US Affiliate United States (151 winners) Boston Area Chapter (Massachusetts, Connecticut, Rhode Island, Maine, Vermont, New Hampshire, and Upstate New...
Article
Special Reports
Advice from a Thriving Entrepreneur
In 2007, Karthik Ramachandran graduated from the University of Colorado in Boulder. His graduate studies brought him to the University of Kansas, where he found himself engaged with the school’s Institute for Advancing Medical Innovation. Since then...
Article
Special Reports
Making a Living, Making a Life
I’m a pharmaceutical professional, toxicologist, project manager, validation specialist, wife, mother, and daughter. I did not get where I am in my career without the support, wisdom, and mentoring of others. My mother, who majored in math and minored in...
Article
Special Reports
Compliance - Standing in the Gray
For eight years I’ve attended ISPE educational sessions across the country, from Kansas City and Saint Louis to Chicago, from Atlanta and Baltimore to San Diego and San Francisco. I’ve learned...
Article
Special Reports
My First ISPE Annual Meeting Experience
As I walked up to the Atlanta Marriott Marquis, the magnitude and grandeur of the building set the stage for how much bigger this ISPE event was than any business event I’d previously attended. The atrium was packed to the brim. There were polished...