July / August 2017

Pharmaceutical Engineering July/August 2017

Cover: Just Getting Started—3D Printing and Bioprinting in Pharmaceutical Manufacturing
3D printing and bioprinting have the potential to transform how drug candidates are tested, how drugs are manufactured, the supply chain, and industry dependence on animal testing. The technology is also being used to create tissue and miniature cellular models, some of which can even mimic the biology of human organs.

Feature: A Good Fit—The Marriage of Pharma and Tech Yields Benefits for Patients
Drug makers are diversifying their portfolios by partnering with technology companies and embracing innovative products such as connected data-gathering medical devices and platforms that collect and analyze patient data. It’s a lucrative space.

Facilities and Equipment: Applying QRM to Improve Sustainability of Pharma Manufacturing
As economic pressures and legislated environmental protection measures continue to increase, the pharmaceutical industry is moving to control cost, reduce energy use, and become a better steward of the environment.

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InTouch
ISPE and the Open-SCS Working Group of the OPC Foundation signed a memorandum of understanding at the 2017 Europe Annual Conference in Barcelona. The OPC Foundation is a global not-for-profit...
InTouch
The biotechnology sector is changing the pharmaceutical manufacturing environment: The trend toward personalized medicine is driving smaller batch sizes with higher production volumes. Digitization and integration of GXP computerized systems will...
Insights
Hi David, I've had a few phone interviews recently, but I never go any further in the process. What am I doing wrong?
Insights
Congratulations, Class of 2017! You have worked hard to become an engineer. Here are a few tips to smooth your transition to industry and allow you to become a contributing member of the pharmaceutical industry. 1. Establish a code of ethics Hold...
InTouch
In late July 2017, ISPE members will have the opportunity to exercise their right to vote for their 2017 Board of Directors. Current ISPE members will receive electronic ballots by email from Intelliscan, Inc., ISPE’s independent election partner....
Features
It is no wonder pharmaceutical companies are looking to enter new health care territory. In 2016 there were only 22 new drug approvals in the United States, returns on investment continue to fall,1 and pricing pressures continued to mount. At the same...
Insights
The Great Lakes region in the American Midwest is home to several pharmaceutical hubs, giving ISPE’s Great Lakes Chapter a deep potential membership pool. And this vast territory also presents the Chapter’s greatest opportunity: to engage more than 800...
Insights
Technology is not new. Biotechnology is not new; it’s new-ish. Yet when the two come together to look at how they can transform medicine, its creation, delivery, and access, well, that is new and can be extraordinary. Extraordinary enough that the FDA...
Insights
A vibrant avenue of research and drug development has opened up with the discovery that epigenetic changes affect gene expression, alter cellular development, and can lead to disease. Epigenetics are chemical modifications that affect gene expression,...
InTouch
The Delaware Valley Chapter is proud to host the longest-running vendor exhibition event in the ISPE community. The chapter held its highly anticipated Annual Symposium and Exhibition on 26 February, in Philadelphia, Pennsylvania. The event gave vendors...
InTouch
The ISPE Europe Annual Conference drew more than 500 people to the Crown Plaza Hotel in downtown Barcelona from April 3–5. With 77 education sessions and 50 exhibitors, the gathering was described by at least one attendee as “the best and biggest...
Technical
We propose a method for demonstrating content uniformity in the context of variables sampling and relate this to the acceptance criteria and probability of passing the USP CU test. We demonstrate that a variable sampling plan with 99.4% coverage between 83.5% and 116.5% of label content is...
Technical
Despite the advantages of ozone technology as a powerful commercially available oxidant and disinfectant, this technology has not been adopted broadly by the pharmaceutical industry. This article contains the rationale for applying ozone technology in a packaged system, which offers greater...
Features
When Aprecia Pharmaceuticals’ anti-seizure medication Spritam (levetiracetam) became the first 3D-printed* drug product to be approved by the US Food and Drug Administration (FDA) in 2016, it also became the first confirmed drug supported by a new team...
Insights
Over the past several years, I’ve presented on various topics aligned with “emerging technology” in our industry. I routinely concluded those presentations stating, “He who has technology wins!” At that time, of course, I was referring to pharmaceutical...
Technical
The following is an example of an evaluation of room air change rates for potential reduction using QRM, providing more detail on engineering considerations.
InTouch
ISPE’s online training courses let you take ISPE’s signature training—the type usually delivered over two to three days in a distant classroom—from your home or office. Courses leverage the expertise of our global membership to provide real-world...