November / December 2018

ISPE Pharmaceutical Engineering Magazine 2018 November - December Issue Cover

Cover: A Culture of Innovation
Pharmaceutical Engineering talks with George Scangos, CEO of Vir Biotechnology, about his thoughts on building a culture of innovation. The former Biogen head also talks about his latest endeavor, a biotech start-up waging war on infectious disease. 

Features: Singapore and Ireland
First, a look at Singapore, a global hub for biopharma and a key player in the market. Next, Jim Breen and Kyran Johnson provide a tour of Janssen Pharmaceuticals’ Ringaskiddy, Ireland, expansion of its global manufacturing capacity for biologics that treat multiple myeloma, rheumatoid arthritis, and Crohn’s disease.

Special Section: Young Professional 2018 Highlights
A Special Section explores the amazing growth of ISPE’s Young Professional community from the first Young Professional event at the 2007 ISPE Annual Meeting to 2018. ISPE Young Professionals held over 60 events in 15 countries this year, drawing more than 2,000 attendees. 
 

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Featured Articles

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...
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,...
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...
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...
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...