Featured Articles

Features
Historically, cell therapies are used to treat patients with cancer after relapse from other approved treatment modalities, or if no approved treatment is available. However, the introduction of allogeneic cell therapies has created exciting opportunities to broaden access to cell-based treatments....
Features
The process of bringing new drugs and products to market requires creativity, thinking outside the box, and the courage to fail numerous times before making a single discovery. This rings especially true now, as the industry faces the COVID-19 pandemic and doubts about vaccines and therapies...
Features
With so many options for personalizing our lives, is the personalization of medicine far behind? With all the data available, how can the industry bring personalized medicine to patients? This article explores what is currently available and where the pharmaceutical industry can move forward to...
Features
This article revisits the concept of phased engineering, procurement, and construction (EPC) and updates it with risk-based considerations specifically regarding the commissioning, qualification, and validation (CQV) of general life-cycle principles for pharma and biotech projects. Enhancing the...
Insights
“The only constant in life is change.” This quote is as true today as it was 2,500 years ago when Heraclitus laid out his philosophy. In the last five years, the word “cure” has been used to describe new therapies targeting many different cancer and hereditary diseases. The potential of these...
Features
The ISPE Global Pharmaceutical Regulatory Summit, held virtually on 28 April 2021, brought together 11 regulators from different parts of the world to discuss how their approaches to GMP inspections have adapted to the COVID-19 pandemic.
Features
A unique aspect of the pharmaceutical industry is the pairing of innovation and regulation. For nearly two decades, ISPE’s Product Quality Lifecycle Initiative (PQLI®) has worked at the nexus of pharmaceutical manufacturing technology and regulation to bring forward solutions that help advance new...
Features
In its 30-year history, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has covered a wide range of topics to generate quality, safety, efficacy, and multidisciplinary harmonized guidelines. As science advances, issued guidelines are...
Features
ISPE’s Regulatory Affairs function plays a vital role in the Society, which is to build effective relationships with regulators and agencies globally and ensure all members have access to the latest regulatory developments and expectations. These activities are driven by the collective efforts of...
Technical
Any systematic pharmaceutical engineering approach for ensuring vial container closure system (CCS) performance must include choosing qualified container closure system components, the proper pharmaceutical process setup, and applicable testing methods. Container closure integrity (CCI) is an...
Technical
Defining room temperature and humidity limits is a frequent topic of debate when designing and operating pharmaceutical and biotechnology facilities. What are appropriate alarm limits and acceptable durations for an alarm condition? Understanding the source of temperature and humidity requirements,...
Technical
Cleanrooms and controlled contamination environments are increasingly being used across many industrial sectors, including the pharmaceutical industry. An important issue is the operating cost associated with cleanroom energy consumption and, consequently, the identification of applicable energy...
InTouch
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.
InTouch
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.
Features
Continuous manufacturing (CM) offers one way the pharmaceutical industry can accelerate development of the drug product control strategy to ensure a robust and reliable supply of medicine to the clinic and/or market. This article explores the promise of continuous manufacturing in enhancing...
Features
Application of continuous manufacturing (CM) in the pharmaceutical industry is gaining momentum. Most of the current experience is based on oral solid dosage (OSD) projects but in the future continuous manufacturing should not be limited to these dosage forms. In this article, the regulatory...
Features
The ISPE OSD Community of Practice Continuous Manufacturing Subcommittee is planning a Good Practice Guide to capture information developed over several years by the team to establish equipment requirements, identify opportunities for harmonization and flexible integration, and suggest where...
Features
Cell and gene therapies are complex. As more therapies come to market in the hope of bringing advanced treatments and cures to rare, orphan, and difficult-to-treat diseases, designing quality standards for these personalized medicines is equally as complex.European Commission. EudraLex, Volume 4:...
Technical
Powder for oral suspension (PfOS) bioavailability is mostly on the basis of drug absorption from the gastrointestinal tract. PfOS formulation pH, viscosity, vehicle buffer capacity, drug particle size distribution, density, and viscosity are often critical for absorption. Therefore, careful design...
Technical
Since 2019, the ISPE France Affiliate’s Unique Device Identification (UDI) Medical Device Work Group has been producing tools to help project stakeholders within the EU or overseas understand and comply with EU regulations of UDIs in medical devices. Some of those tools are highlighted in the...
Technical
Software as a medical device (SaMD) is software intended to be used for one or more medical purposes without being part of a medical device.International Medical Device Regulators Forum. “Software as a Medical Device (SaMD): Key Definitions.” 9 December 2013....
Features
This second of a two-part series explores digital transformation and digitalization in the biopharmaceutical industry with information about how data science enables digitalization along the product life cycle. (Part 1 was published in the March-April 2021 issue of Pharmaceutical...

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Latest Articles

iSpeak Blog
In September 2021, a panel of regulators representing ANSM (France), ANVISA (Brazil), FDA (US), and the WHO participated in a webinar to discuss opportunities for drug shortage prevention. The discussion was facilitated by industry leaders while industry insights were obtained through polling of...
iSpeak Blog
The uncertainty that comes with the introduction of a new idea has affected society for centuries. We all grew up hearing about how sailors of old feared sailing off the edge of the world before we accepted that the Earth was indeed round. Inventors are always ridiculed by naysayers until their...
iSpeak Blog
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from October 2021. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.
iSpeak Blog
The ISPE Aseptic Conference is in its 31st year. This year like many others, we have a long list of enigmatic speakers discussing topics that matter to your everyday business. But unlike in years past, we have more to celebrate. After a long period with us pouring our energy into producing the...
iSpeak Blog
Late last month, ISPE published the 2nd Edition of the ISPE Good Practice Guide: Good Engineering Practice. This revision comes a decade and a half after the original guide was published and is the culmination of a year-long effort of a multi-national, cross-functional team of industry experts....
iSpeak Blog
ISPE’s Facility of the Year Awards (FOYA) celebrates cutting-edge engineering, new technology, and unique collaborations. It provides a platform for the pharmaceutical science and manufacturing industry to showcase accomplishments in facility design, construction, and operation, new applications of...
iSpeak Blog
Since the FDA issued final guidance on Data Integrity in 2018, the challenges have been many. The growth in observations has been substantial. With IT transforming dramatically over the last 20 years, the alignment of the people, processes, and tools and the data they collectively manage produces...
Insights
Pharmaceutical Engineering® has announced the finalists and winners of the Roger F. Sherwood Article of the Year for 2019 and 2020. The 2019 award finalists and winner were not announced last year due to the pandemic. Winners of both awards are being recognized at the 2021 ISPE Annual Meeting &...
Insights
The 2021 ISPE Annual Meeting & Expo brings my year as ISPE International Chair of Emerging Leaders (EL) and Emerging Leaders representative on the ISPE International Board of Directors to an end. I would like to say thank you to all the Emerging Leaders members and volunteers for the hard work...
iSpeak Blog
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from September 2021. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last month.
iSpeak Blog
Erich Bozenhardt is a BioProcess SME and internationally recognized authority in the domains of cell and gene therapy and bioprocessing. He is a Lead Process Engineer in Regenerative Medicine Operations at United Therapeutics Corporation. During his career, Erich has led the process activities for...
iSpeak Blog
There are many benefits to networking. In addition to strengthening business connections and meeting new people, it can help you discover new ideas and gain a fresh perspective on topics in the life sciences and pharmaceutical industries. It can help you advance your career and learn about new...
iSpeak Blog
ISPE’s Pharma 4.0™ initiative provides guidance, aligned with the regulatory requirements specific to the pharmaceutical industry, to accelerate Pharma 4.0™ transformations. Also known as the Smart Factory, the objective of Pharma 4.0 is to enable organizations involved in the product lifecycle to...
iSpeak Blog
One of the most significant changes to the pharmaceutical industry in the last decade has been the increased speed in developing new therapies. A striking example of this is the rapid rollout of the COVID-19 vaccines. What usually took 10-15 years was researched, developed, and put into production...

Current Issue

November / December 2021

AI’s Promise for ATMPS Cover: Industry 4.0 applications in biopharma involve the complete spectrum of data science throughout the entire product life cycle of many disparate entity types. Tools such as digitalization, modern data science, and the industrial internet of things are becoming requirements for modern implementations including advanced therapy medicinal products (ATMPs). This article...