Latest Articles

iSpeak Blog
There is a paradigm shift occurring in the biomanufacturing space around the advancement of personalized medicine that is creating new challenges for biomanufacturing facility design, both in terms of process technology and facility development...
iSpeak Blog
Each year during the ISPE Annual Meeting & Expo, the ISPE International Honor Awards Committee acknowledges exceptional efforts, recognizing individual volunteers, affiliates and chapters, students, the company of the year, and the Facility of the...
iSpeak Blog
Over 2,000 attendees from more than 28 countries gathered in Philadelphia for the 2018 ISPE Annual Meeting & Expo. The opening plenary on Sunday, 4 November provided a strong kickoff to the four-day conference, whose theme of “Vision to Reality”...
iSpeak Blog
Conference Essentials Conference Agenda Travel Tips Registration and Information Hours Sunday, 4 November | 0700–1800 Monday, 5 November | 0700–1730 Tuesday, 6 November | 0700–1730 Wednesday, 7 November | 0700–1130 Expo Hall Hours Sunday, 4...
InTouch
It has been an incredibly busy year for the IYPC as we delivered the strategy that was presented to the International Board of Directors at last year’s Annual Meeting in San Diego (and published in the January-February 2018 issue of Pharmaceutical...
InTouch
Globally, there was one YP event per week for the entire year. There were a great variety of technical events, facility tours, networking evenings (including “speed networking”), as well as career- and leadership-development seminars. YP committee...
iSpeak Blog
Aseptic filling of parenterals is one of the most challenging tasks within pharmaceutical manufacturing. There is a wide range of challenges from engineer driven tasks like filling accuracy and machine performance to pharmaceutical key questions like...
InTouch
This year, ISPE Young Professionals held over 60 events in 15 countries, drawing more than 2,000 attendees—an amazing testament to the growth of the YP community. This Special Section details the success of these global activities and the IYPC’s exciting work over the past year.
Technical
Although it includes some background material, this article is based predominantly on a series of interviews with SMEs at Eli Lilly, Janssen, Hovione, C-SOPS, and Patheon from October to December 2017. The comments and observations that follow are theirs.
Insights
A wide range of pharmaceutical products is produced using two complex fermentation processes. Anaerobic fermentation takes place in the absence of oxygen, and aerobic fermentation requires oxygen, supplied via blower and compressor systems, to yield microorganisms and produce the desired product....
Insights
Richi Sethi, a Design Engineer for Biocon, India’s largest biopharma company, knows that process engineering involves constant adaptation. “We have to be very dynamic,” she explained. “People want to try new things, and we have to be on the forefront.”
Insights
Six Sigma is an approach for pharmaceutical manufacturing quality that can help to eliminate drug shortages and recalls and improve performance issues. Lawrence Yu, PhD, Deputy Director, Office of Pharmaceutical Quality, FDA Center for Drug Evaluation and Research (CDER), provided an overview of...
InTouch
The ISPE International Board of Directors 2018 election results are in after member voting during the summer. The new slate of officers and directors has been named. Board members govern and chart the Society’s strategic direction during their terms of...
iSpeak Blog
Philadelphia, the "City of Brotherly Love", is home for the second time to our 2018 ISPE Annual Meeting & Expo! What better a place to host our annual conference than the second-largest city on the east coast and one of the top 10 pharma hubs in...
Insights
In November, ISPE introduces PE Online, a new web-based reading platform for Pharmaceutical Engineering. It is your central place for PE content, including information on trends, developments, technology, and scientific research. PE Online is part of the...
iSpeak Blog
The 2018 ISPE Annual Meeting and Expo is less than two weeks away and time is running out to register for the pharma event of the year. Philadelphia - the city of “Brotherly Love” – will host this year’s Annual Meeting and provide an amazing educational...

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Featured Articles

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
A corporate culture that supports creative thinking can help pave a road to innovation. Free people from fear and encourage them to do their best and you’ll have an environment for accomplishing great things, according to George Scangos, who has led Biogen and other pharma companies. In a recent...