May / June 2018

May/June 2018

Cover: The Rise of Biopharmaceutical Manufacturing in Asia
Biopharmaceuticals are booming in Asia, buoyed by enhanced regulations, an influx of venture capital, a culture of innovation, and government support. Asian pharmaceutical manufacturing has traditionally focused on generics, but things are changing.

Feature: Lego Blocks for Chemists—The Advent of Continuous Manufacturing
Spurred by pressure from governments and consumers to curb rising drug prices, pharmaceutical manufacturers are increasingly willing to look beyond traditional batch processing to cut costs and increase efficiency. Markus Krumme, Head of Continuous Manufacturing at Novartis, shares his thoughts on one of the industry’s most dramatic innovations.

Feature: Supply Chains—Dramatic Changes Ahead
Biopharmaceutical supply chains are undergoing dramatic changes. Predominant among these is the shift away from primary care to specialty products and personalized medicine, and from large-scale production of low-value small molecules to low-volume, high-value biologics. Andy Skibo, Head of Global Biologics Operations and Engineering, MedImmune/AstraZeneca, tells us why specialty product supply chains must be managed in a different way.

Subscribe to May / June 2018
Features
Biologics are large-molecule drugs, derived from a biological source, that treat chronic diseases such as cancer and autoimmune disorders. While small-molecule compounds continue to account for the bulk of pharmaceutical profits, biologics’ presence is...
Insights
As this is my first Pharmaceutical Engineering editorial, let me introduce myself. I have been in the pharmaceutical industry for the last 41 years. Over time, I became the global head of quality for three major pharmaceutical companies. I’ve lived and...
Technical
In-line concentration solves problems found in mAb production, including insufficient storage capacity and process tank volumes, extended processing times, and large hold-up loop volumes for ultrafiltration concentration. It optimizes the ion-exchange step following capture, reduces costs and...
Features
Biopharmaceutical supply chains are undergoing dramatic changes that will affect the design and operation of the facilities of the future. Predominant among these is the shift away from primary care to specialty products and personalized medicine, and from large-scale production of low-value small...
Features
Change in the pharmaceutical industry is notoriously slow, so it wasn't surprising that many doubted continuous manufacturing (CM) would ever be adopted. But despite the skeptics, the technology is gaining substantial ground. Since 2015, four solid oral drugs produced by continuous processes have...
Features
Spurred by pressure from governments and consumers to curb rising drug prices, pharmaceutical manufacturers are increasingly willing to look beyond traditional batch processing to cut costs and increase efficiency. One of the industry's most dramatic innovations on this front is continuous...
InTouch
ISPE's 2018 Facilities of the Future Conference highlighted emerging technologies that are driving change in pharmaceutical manufacturing. Topics included virtual reality, robotics, artificial learning, machine learning, and 3D printing. Education sessions were divided into Industry 4.0 and...
InTouch
In March 2017, ISPE submitted an extensive and detailed response 1 to the 2016 US Food and Drug Administration (FDA) draft guidance "Submission of Quality Metrics Data," 2 the associated Federal Register Notice, 3 and webinar. 4 These comments reflected ISPE's conclusion that the program, as...
InTouch
Home to more than 51 million people, South Korea is one of the "Four Asian Tigers," along with Hong Kong, Singapore, and Taiwan. These countries experienced rapid expansion and high growth rates beginning in the 1960s, developing into highly advanced economies. South Korea's pharmaceutical industry...
InTouch
ISPE's revised IT Infrastructure Control and Compliance Guide provides comprehensive guidance on regulatory expectations for both traditional and cloud-based IT platforms. Have we done enough?
InTouch
Special interest groups (SIGs) have been an important part of ISPE for many years. SIGs are formed around a specific area of interest, policy, or technology in which members have identified a common challenge. These "microcommunities" foster interaction among a variety of technical domains and...
InTouch
The ISPE Japan Affiliate conducted its annual pharmaceutical plant tour last October, visiting four US plants prior to attending the ISPE 2017 Annual Meeting & Expo in San Diego, California. Twenty-one professionals participated from all over Japan,...
Insights
Ten years after its publication, the ISPE GAMP® 5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems is regarded as the definitive industry guidance on GxP∗ computerized system compliance and validation for companies and suppliers and is...
Insights
Biogen recently partnered with ISPE student chapters to host an evening of conversations about careers in the industry. During the event, I talked about job searching with some of the more than 200 attendees. Applications One frustrated student told me...
Insights
Vasant Narasimhan Digital technologies and big data tools are changing every aspect of how companies operate, across myriad industries. Healthcare is no exception. We...
Features
Biopharmaceuticals are booming in Asia, buoyed by enhanced regulations, an influx of venture capital, a culture of innovation, and government support. Asian pharmaceutical manufacturing has traditionally focused on generics, but things are changing. 1 , 2 In South Korea, biologics powerhouse...
Insights
As part of my tenure as International Young Professionals Chair, I have the amazing opportunity to be a member of the ISPE International Board of Directors. At a recent board meeting, I sat down with six directors to ask them for advice on how to develop...
Insights
"Local and regional relevance" is a key component of our strategic plan, and one that is critical to our success as an organization. It pledges us to "understand and shape strategy to the business, culture, and regulatory issues of local and regional markets." Here are a few ways in which we are...
Features
Although pharmaceutical manufacturing is traditionally a change-averse industry, the benefits of continuous processing demonstrated in other industries are beginning to drive interest in its application to bioprocessing. This article reports on...