Featured Articles

Features
In a recent advanced therapy medicinal products (ATMPs) innovator survey, two-thirds of respondents reported that they are developing multiple drug platforms.CRB Group. Cell and Gene Therapy Report. 2020. http://go.crbgroup.com/2020-horizons-atmp Without a guarantee of commercial success for any...
Features
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...
Features
What do recipients of ISPE’s prestigious Facilities of the Year Award (FOYA) know that has helped their projects succeed? What are the lessons learned from achievements in facilities development, including forward-looking projects that encompass and inspire changes in the industry? Pharmaceutical...
Special Reports
In 2020, the world was grappling with how to slow the spread of the SARS-CoV-2 virus and appropriately treat people who had the COVID-19 infection without approved therapies or vaccines. In two years, there are multiple vaccines and treatments along with great knowledge about the virus—and about...
Special Reports
Operation Warp Speed coordinated US government support of the pharmaceutical industry’s effort to develop and deliver vaccines and therapeutics across the United States to fight the COVID-19 pandemic. This article provides an inside look at the work done by this team to address the threat posed by...
InTouch
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...
Technical
Advanced therapy medicinal products (ATMPs) pose specific manufacturing challenges beyond those typically addressed by pharmaceutical chemistry. Often in current ATMP applications, a change in approach is introduced at some point in the development process out of convenience or necessity, which...
Technical
The implementation of a mammalian cell-based biopharmaceutical manufacturing process demands robust methods for knowledge handling, from early-stage development and technology transfer to production scale. Mathematical process modeling can summarize this knowledge as the relationships of critical...
Technical
Heightened awareness, due to the pandemic, of the need for domestic manufacturing capacity has rejuvenated the biopharmaceutical manufacturing industry and resulted in new commissioning projects. However, cross-country/continental travel restrictions and social distancing–based work protocols...
Features
During the past decade, industry has experienced a proliferation of regulatory divergence regarding the interpretation and implementation of International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines (and control strategies) across...
Features
With the rise of new technologies and predictive analytics capable of handling the huge amounts of data within and across existing information systems, Industry 4.0 has been thriving in many sectors, such as industrial automation, financial technology, retail, and semiconductors. But the health...
Features
Developing comprehensive digital solutions is crucial for the entire value creation process for pharmaceuticals. A holistic view of the interrelations of product, production process, and plant is becoming increasingly significant. In this context, the application of model-based technologies...
Technical
Good data are a characteristic of good science. Quality data are arguably more important today than ever before and are considered by many to be a corporate asset because they are used to develop products and processes, control our manufacturing processes, and improve products and processes when...
Technical
This article presents the results of applying artificial intelligence (AI), such as machine learning algorithms, to identifying and predicting anomalies for corrective maintenance in a water for injection (WFI) processing plant. The aim is to avoid the yearly stoppage of the water for injection...
InTouch
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.
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...
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...

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Latest Articles

iSpeak Blog
Pharma 4.0™ is a new category for the Facility of the Year Awards (FOYA) program. Winners in the Pharma 4.0 category embody the Pharma 4.0 concept. This includes not only implementing at least one technological innovation, but also demonstrating the ability to change the company’s culture,...
iSpeak Blog
ISPE GAMP® has led the way in computerized systems best practices for more than 30 years. GAMP brought us the concept of system lifecycles and leveraged the V-model to give us a structured approach to computerized systems validation (CSV). GAMP developed and adopted the risk-based approach to CSV,...
iSpeak Blog
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...
iSpeak Blog
Following an unprecedented two years in which the pharmaceutical industry has faced numerous challenges posed by the global pandemic, pharmaceutical manufacturing has had to react and respond to meet the rapidly changing requirements and timelines. This has necessitated a radical rethink in how we...
iSpeak Blog
Continuous manufacturing (CM) is gaining traction in pharmaceutical manufacturing. The purpose of this post is to highlight some of the differences between small molecule Drug Substance (DS) and Drug Product (DP) continuous manufacturing (CM), which may be helpful in considering the development and...
iSpeak Blog
Gaelle Saint-Louis is the Women in Pharma® (WIP) Chair of the ISPE San Diego Chapter. She began her involvement with ISPE as the Young Professional (now Emerging Leaders) Chair for the Greater Los Angeles Chapter in 2019. After relocating to San Diego, she took on a leadership role within the...
iSpeak Blog
Featured in this edition of the Pharmaceutical Engineering® Online Reading Roundup are answers to our most frequently asked questions about publishing in PE. We welcome submissions from members and nonmembers and have a wealth of information available to help guide your journey to becoming a...
iSpeak Blog
If you take care of your employees, they will take care of your customers. Once you stop treating people like functions or costs, disengaged workers begin to share their gifts and talents toward a shared future.
iSpeak Blog
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from May 2022. 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
Paperless Validation is a current topic of interest within the pharmaceutical industry with many companies now adopting or planning to adopt paperless solutions with the promise of improved data integrity and significant efficiency improvements to their existing paper-based validation processes.
iSpeak Blog
It goes without saying that reflecting on the last few years, immense progress has been made in the biopharmaceutical industry. We have seen an industry prioritising collaboration and innovation, combined with a healthy competitive spirit, brought new technology to reality, and achieved milestones...
iSpeak Blog
It would be easy to say that the pandemic has driven dramatic growth for CDMO companies, as more pharmaceutical firms seek to outsource. Really though, the trend started much earlier, with many CDMOs having put their massive expansion plans in place a year or more before the pandemic took hold.
iSpeak Blog
The ISPE South Central Chapter recently hosted their Inaugural South Central Chapter Education Seminar from College Station, while live-streaming in Austin, Houston, Dallas-Fort Worth Area (DFW), and The University of Oklahoma. Each city hosted an in-person networking dinner followed by the...
iSpeak Blog
mRNA is back at the 2022 ISPE Biotechnology Conference. Last year we learned from major key players about their journey to develop first time mRNA vaccines against COVID-19 and build manufacturing capacity for billions of doses in less than one year. In 2022 we are revising the relevance of mRNA...
iSpeak Blog
Introduction ISPE’s ICH Q12 Implementation Team, a technical team under the auspices of ISPE’s Product Quality Lifecyle Implementation (PQLI)® committee, recently worked with Health Canada (HC) to develop and present training to HC reviewers and inspectors.
iSpeak Blog
Background The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)’s Quality Risk Management (QRM) guidance was signed off by ICH in November 2005 as one of a suite of guidelines alongside Q8,...
iSpeak Blog
Think Tanks are meant to mobilize expertise and ideas to influence processes and procedures and help address global issues – a concept perfectly in line with the goals and mission of ISPE, the pharmaceutical industry’s largest nonprofit association committed to connecting over 20,000 peers across...
iSpeak Blog
In 2022, supply chain challenges have been present in the news every day. Whether it is oil, computer chips, drugs, or baby formula, we have been made aware about how fragile our supply chains are and how many companies are hard at work trying to shore up current supply lines, while preparing for a...
iSpeak Blog
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from April 2022. 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
Knowledge management is a vital tool for sustaining competitive advantage and improving performance. It is the conscious process of acquiring, analyzing, storing, and disseminating information related to products, manufacturing processes, and components.

Current Issue

May / June 2022

Viral Vector Platforms: Intersection of Facility And Program Cover: Realizing the promise of any novel viral vector therapeutic depends on the innovator’s ability to constantly meet evolving program requirements set in the product’s preclinical; clinical; chemistry, manufacturing, and controls; and market strategies. A key enabler to success is establishing a robust yet nimble viral vector...