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 conversation with PE, Scangos shared his approach to building a culture of innovation and provided updates about his latest endeavor, Vir Biotechnology, whose mission is the war on infectious disease.

Latest Articles

iSpeak Blog
2018 ISPE Europe Aseptic Conference Recap More than 200 attendees from manufacturers and key suppliers attended ISPE’s first European conference on aseptic manufacturing in the old capital of the Austrian Hungarian Monarchy Capital, Vienna. Austria is a...
iSpeak Blog
Many reasons to celebrate In the last week of November, the inaugural ISPE Europe Aseptic Conference took place in Vienna, Austria. With its emphasis on innovation in aseptic processing with focus on new regulation and pharma 4.0, this conference drew...
iSpeak Blog
As the end of the year approaches, many people are commenting how quickly this year has passed. This time of the year is when we typically reflect on our accomplishments and start strategizing next year’s goals. Taking proactive actions for our own...
iSpeak Blog
Student Poster Competition Undergraduate Winner The 2018 ISPE Annual Meeting & Expo completely exceeded my expectations in all aspects from the: Lessons I couldn’t have learned anywhere else, What-I-thought-was-impossible networks I...
iSpeak Blog
The growth of single-use technology (SUT) has revolutionized the bioprocess industry. The implementation of single-use technology (SUT) has typically been a trial and error exercise for the end users. A publication that provides a road map for...
iSpeak Blog
The 2018 ISPE Annual Meeting & Expo took place in Philadelphia this year. Philadelphia, the city with the oldest square mile in United States, has a lot to offer. I have spent the last twenty years of my life here, so I am speaking from experience....
iSpeak Blog
Biotech has a huge impact on our world. Biotech innovations provide novel treatments to cure diseases such as cancer and Alzheimer’s syndrome. Biotech brings new, sustainable products to the market. Biotech companies already conquer the world’s beef and...
iSpeak Blog
Regulators from three global agencies—US FDA, MHRA, and Brazil’s ANVISA—discussed how their agencies are addressing emerging therapies during the “Global Regulatory Town Hall” on 6 November at the 2018 ISPE Annual Meeting & Expo. “Precision medicine...
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 Year...
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.”

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...