Pharmaceutical Engineering November / December 2018

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George Scangos, CEO of Vir Biotechnology, talks with PE 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.

A Culture of Innovation

Cover: 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. 

Singapore and Ireland

Feature: 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.

Young Professional 2018 Highlights

Special Section: 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. 

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 conversation with PE, Scangos shared his approach to building a culture of innovation and provided...

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 key factors around the move to Six Sigma quality in pharma manufacturing in his presentation “The...

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

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. This article examines the role of aeration equipment in aerobic fermentation, considerations when...

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...

  • 1Fotheringham, S. “The Rise of Biopharmaceutical Manufacturing in Asia.” Pharmaceutical Engineering 38, no. 3, (May-June 2018): 10–13.
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.

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 multiple myeloma, rheumatoid arthritis, and Crohn’s disease.

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.

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

  • 1US Food and Drug Administration. Guidance for Industry. “Expedited Programs for Serious Conditions— Drugs and Biologics.” May 2014.
Technical

Although other industry publications have explored the effect of surface finish on biofilm formation, background data indicating that imperfections exceeding the American Society of Mechanical Engineers (ASME) Bioprocessing Equipment (BPE) standard are detrimental to chemical cleaning performance are lacking.1

  • 1Arnold, J. W., and O. Suzuki. “E ects of Corrosive Treatment on...