Features
– Being on the cutting edge of drug development is the goal of most pharmaceutical companies, but a new drug won’t work if the patient doesn’t take it. It’s a vexing problem that developers of healthcare technologies hope to address.

Latest Articles

iSpeak Blog
The concept of the digital twin sounds like science fiction: a complete digital representation of your process or system, along with all the flexibility to play with simulations, creating feedback, and targeting optimizations. However, the foundation for...
iSpeak Blog
Featured in this edition of ISpeak iSpeak Reading Roundup are the top blog posts from June 2019. Explore critical- industry initiatives, membership Membership highlights, and more for what the pharmaceutical industry was reading last month. The...
Technical
The unavailability of a backup pharmaceutical water system has been a severe limitation for pharmaceutical manufacturers. Until recently, qualification concepts that adhered to current Good Manufacturing Practice (GMP) guidelines hindered the rapid setup of a water system. A new, tailor-made...
Special Reports
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.
Special Reports
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...
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...
iSpeak Blog
What is coming next in biopharmaceutical manufacturing? That question was addressed in plenary sessions at the 2019 ISPE Biopharmaceutical Manufacturing Conference 18-20 June in Boston on the second and third days of the conference. (For more about the...
iSpeak Blog
Bart Van Acker Managing Partner Quality By Design NV You’ve been with ISPE for quite some time now. Can you please give me a little information on some of...
Insights
Many of us have heard of Moore’s Law, named after Gordon Moore, cofounder of Intel 1 . Moore’s Law predicted that computing would increase in power and decrease in relative cost at an exponential pace. This allows us to use this power for new technologies such as machine learning and artificial...
iSpeak Blog
ISPE's professional pharma training allows for industry members to study challenges, develop solutions, and gain a better understanding of best practices and advancements in pharmaceutical science. The interactive discussions are led by subject matter...
iSpeak Blog
Recap of the 2019 ISPE Biopharmaceutical Manufacturing Conference The latest in the fast-moving journey—some call it a revolution—of biopharma development were well represented at the 2019 ISPE Biopharmaceutical Manufacturing Conference in Boston, MA on...
Technical
In this article, a new method for the analysis and comparison of dissolution profiles is proposed and illustrated with case studies. This useful strategy makes effective use of dissolution profile data by using all data in each profile to create two...
InTouch
ISPE launched its complimentary Pharma Best Practices Webinar Series in April. The debut was outstanding, drawing more than 850 registrants and over 500 real-time participants representing 62 countries and six regulatory agencies from around the world.
InTouch
Delaware Valley Chapter Executive Vice President Eleanor Small, 34, is a woman with a passion for science and technology. Although still early in her career, she has already accomplished a lot, including being awarded the prestigious Delaware Valley Young Engineer of the Year award for 2019.
iSpeak Blog
Manufacturing biopharmaceuticals has many challenges requiring a clear understanding of every product’s goals and priorities. These challenges will only increase as more sophisticated products and therapies are developed.1 One of the recent advances in...
Insights
I’ve been to numerous ISPE conferences in the United States. This was my first ISPE Europe Annual Conference , held 1–4 April, and it did not disappoint! The Young Professionals (YPs) were an integral part of the conference in Dublin; they led tracks, hosted and participated in the ISPE Europe...
iSpeak Blog
Solano Community College Hosts Advisory Panel to Honor First Graduating Class On 22 April 2019, more than 40 professionals and students attended the ISPE- Solano Community Advisory Panel at Solano Community College. This event was held in honor of the...

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Featured Articles

Features
The Pharma 4.0 Special Interest Group is focusing on key technologies that will modernize pharmaceutical manufacturing and facilitate digital transformation. These technologies include digital twins, augmented reality, artificial intelligence, big data and analytics, mobiles, cloud, advanced...
Features
To facilitate the assessment and mitigation of compliance risks associated with a third-party service organization, its services, and the systems used to provide the services, this article proposes adopting an approach from the financial sector that, with a little modification, could be used to...
Features
To meet the EU serialization deadline on 9 February 2019, pharmaceutical companies and their contractors have had to reorganize their manufacturing lines and logistics to ensure compliance with the EU’s Falsified Medicines Directive (FMD) of 2011 and the EU Commission Delegated Regulation 2016/161...
Features
Continuous manufacturing (CM) is an advancement in pharmaceutical manufacturing technology that provides high assurance of product quality as well as enough flexibility and agility in production to respond to market demands. The decision to invest in CM can be challenging for a company given the...
Features
The 2018 ISPE Biopharmaceutical Manufacturing Conference on 10–12 December in Huntington Beach, California, provided information about future-oriented developments in the burgeoning area of biopharmaceutical manufacturing—and also shared insights into the achievements that are already underway....
Features
This article examines patient preferences in one facet of clinical research: the experience related to the use of investigational medicinal products (IMPs). As patients have become more involved and informed in their healthcare choices, the “voice of the patient” has been increasingly incorporated...
Features
It is the duty of the government to improve access to safe, effective, and quality medicines for its constituents. Various approaches are taken by different countries to achieve this; for the Philippines, the approach is through the active promotion of...
Features
In Japan, off-patented drugs are not always converted to generic drugs but may remain on the drug list as off-patented-drug products. These are customarily classified into three groups: patented drugs; off-patented drugs (“long-listed drugs”); and...
Features
Data is an important factor that is reshaping the pharmaceutical industry and triggering significant innovation. Vertical integration of equipment can represent an optimal solution to manage the increasing flow of data efficiently, innovate the manufacturing environment, and fulfill data integrity...
Features
The 2018 ISPE Quality Manufacturing Conference , held 4–6 June 2018 in Arlington, Virginia, included a well-attended session entitled “Data Integrity—Beyond the Lab,” which reaffirmed continued focus from both industry and regulators on this critical element of assuring product quality and patient...
Features
Pharmaceutical Engineering magazine’s March–April 2016 Special Report 1 highlighted the increasing importance of data integrity for companies throughout the global GMP-regulated industry. This is especially true during health authority inspections. 2 , 3 , 4 Pharmaceuticals, biotech, and API...
InTouch
Enhanced and accelerated regulatory pathways for “Breakthrough Therapies (United States) and “PRIME” medicines (European Union) have been introduced to provide faster access to exciting new therapies developed to treat unmet medical needs.1,2 Jokura et...
Features
Janssen is in the midst of a multimillion-dollar expansion project at the company’s Ringaskiddy, County Cork, manufacturing facility in Ireland. The 19,100-square-meter project is expected to significantly increase Janssen’s global manufacturing capacity for producing biologic medicines for...
Features
Our May-June cover story on the rise of biopharmaceutical manufacturing in Asia noted that “Biopharmaceuticals are booming … buoyed by enhanced regulations, an influx of venture capital, a culture of innovation, and government support.” 1 While that report focused principally on China, Indonesia,...
Technical
This article illustrates the importance of experimental conditions to evaluate analytical methods. Italicized text is used throughout the article to emphasize key points and illustrate formula variables.
Features
Innovative technology for in-line real-time powder flow monitoring based on drag force flow measurement offers great potential for efficient monitoring of powder-processing operations.
Special Reports
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.

In This Issue

Features
Being on the cutting edge of drug development is the goal of most pharmaceutical companies, but a new drug won’t work if the patient doesn’t take it. It’s a vexing problem that developers of healthcare technologies hope to address.