Insights

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....
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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.”
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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...
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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...
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On 19 June, ISPE officially launched the ISPE Foundation. The philanthropic arm of ISPE "will enhance ISPE's ability to support its members and the pharmaceutical industry as they prepare to address new and evolving industry demands," according to Michael A. Arnold, ISPE Foundation Board Chair, and...
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I write my final "Message from the Chair" article full of a range of thoughts and emotions. Perhaps the best way to sum up my feelings is just to say, "Time flies when you're having fun."
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My conversation with six members of ISPE's Board of Directors continues this month.
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I am pleased to have another opportunity to share some thoughts and provide a quick update about the progress of ISPE. It is hard to fathom that we are halfway through 2018, and summer is upon us (at least those of us in the Northern Hemisphere). ISPE had a very busy first half of the year, with...
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In our industry, as in many others, the most important goal is developing and delivering a product that satisfies our customers. In our industry, the end customer is the patient.
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The importance of ensuring data integrity is reflected in guidance, citations, and public comments of regulators and health agencies. A number of companies have suffered serious regulatory and financial consequences as a result of unacceptable...
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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...
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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...
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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...
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Vasant Narasimhan Digital technologies and big data tools are changing every aspect of how companies operate, across myriad industries. Healthcare is no exception. We...
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Imagination is more important than knowledge. Knowledge is limited. Imagination encircles the world. —Albert Einstein
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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...
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In my last column,1 I introduced the Regulatory Steering Committee, which was convened to provide guidance and oversight for ISPE’s regulatory committees and initiatives. This column focuses on the committees and groups that carry out this important work...
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This issue highlights a variety of voices and points of view on matters ranging from sustainability to serialization, Pharma 4.0 to viral contamination, and EMA’s new location to game theory. In our cover story, Scott Fotheringham, PhD, interviews...
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Fellow members, it is my pleasure to provide a short update on some of ISPE's accomplishments, its strategic plan, and ongoing activities.
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I was inspired to write this editorial after attending the YP and Student Brunch at the 2017 ISPE Annual Meeting & Expo, where Kelly Keen, a member of the ISPE Board of Directors, shared her story. In particular, she emphasized that traveling had...
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Which road map to Industry 4.0 (I4.0) should the pharma industry follow? We explored this question during the YP workshop held during the Verona conference, leveraging “gamification” (a learning technique that incorporates game elements) to determine a...
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From November 23 to 24, over 230 participants from 19 countries gathered in Verona—located in Italy’s high-tech corridor—for a conference focused on the challenges and opportunities of Pharma 4.0. Organized by ISPE Italy and the Pharma 4.0 Special...
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Organizations often augment their workforces to address temporary work requirements. These appointments can range from long-term consulting engagements for complex projects to short-term coverage for employee absences. Over the years, I have spoken with...
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The United Kingdom's (UK) "Brexit" vote to leave the European Union (EU) by March 2019 has created challenges for the European pharmaceutical industry. Among the first important decisions resulting from the impending departure was where to relocate the European Medicines Agency (EMA), currently...
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We all know the saying: There’s no reason to reinvent the wheel. It is likely that someone else has already come up with a workable solution to your particular challenge. We also know the quickest way to conquer challenges is to find that person, learn...
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One year ago, I wrote about the industry’s collective pathway to hope, lit by the desire to alleviate human suffering. One year on, extraordinary forms of hope became reality with the approval of CAR T-cell therapy, emergence of CRISPR technology, and...
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$38B of manufacturing value, 71% of which is exports 2nd in Europe for pharmaceutical production Italy exports 85% of the API it produces 42% of employees are women; 52% in R&D 40% of companies are Italian owned Exports have grown 52% since...
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  One of my key takeaways from the ISPE 2017 Annual Meeting & Expo is that as an industry, we need to focus on innovation. Keynote speakers from Pam Cheng and Roger Connor to Enno de Boer and Glenn Pierce reminded us that innovative thinking must...
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Beginning in 1932, the US Public Health Service conducted an infamous research project—the Tuskegee Syphilis Experiment—designed to follow the course of untreated syphilis. The unwitting participants were poor African-American men in Alabama, who were...
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Most companies leverage social media as part of their recruiting strategy, so if you don’t use it in your job search you put yourself at a huge disadvantage. First, determine your brand: How do you want others to see you? Who do you want to find you?...
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The end of a year, the start of a new job, a groundbreaking scientific development: These are events that give us pause, moments that help us transition to a new mind-set, focus, or even a new career. Managing these moments is as important as being a...
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Roughly 29,000 Americans die of Clostridium difficile infections every year. This gram-positive bacterium produces severe intestinal disease, with fatality rates ranging from 6% to 30%. Because the spores are hard to kill and can remain viable for years,...
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A hero is someone who has given his or her life to something bigger than oneself. — "The Hero's Adventure," in ' The Power of Myth' , by Joseph Campbell with Bill Moyers, 1988
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Many spend their summer relaxing, perhaps traveling, but generally trying to “put their feet up.” Others change the course of health care as we know and practice it. Gilead’s 28 August purchase of Kite Pharma, one of the companies developing chimeric...
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Hi David, I've had a few phone interviews recently, but I never go any further in the process. What am I doing wrong?
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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...
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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...
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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...
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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,...
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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...
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Megan was diagnosed with Type 1 diabetes in 2007 when she was five months pregnant with her first child. She began the routine, familiar to many of the 415 million diabetics worldwide, of measuring her blood glucose levels with finger pricks, followed by...
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Michael Schmitz is Vice President, Planning and Logistics, of Vetter Pharma- Fertigung GmbH & Co. KG. In this position he is focused on logistics operations, production resources, OEE measures and customer service...
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Manufacturing therapeutic proteins such as monoclonal antibodies, while potentially lucrative, is fraught with uncertainty. A company can have a number of biologics in the pipeline, each requiring an estimate of future need for a variety of indications,...
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A country best known for its artists, food, and fashion designers, Italy is also home to a thriving pharmaceutical industry. Along the country roads that stretch from Milan to Bologna, Florence, deep into Rome and Naples, idyllic hillsides are dotted...
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Already in its 26th year, ISPE’s annual Aseptic Conference continues to be the place to go to for the latest and greatest in barrier/isolation technology, small- and large scale aseptic manufacturing, and disposables. The conference presents fantastic...
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Leaving the familiarity of a college environment, and beginning your career can be both exciting and intimidating. It’s a time when you are expected to put your years of education into practical use. However, even with a degree in hand, you still face a...
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“Industry 4.0” is the networking of information that became possible after several years of disruptive technological innovation. You may have heard related terms such as big data, real-time data, patient data, knowledge management, data analytics, and...
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"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...
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When we discussed assembling this month’s special report on sustainability, the idea of pairing it with an issue on compliance challenges was not an obvious choice. Despite those initial misgivings, the reality is that these two topics are a superb...
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Now that we’re all finding smart mentors and career coaches (see the YP State of Mind article in the January-February issue of Pharmaceutical Engineering), I want to reflect on an important skill: perseverance. Engineers and scientists by nature look...
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The Pharmaceutical Engineering November-December 2016 editorial, “Collaboration Key in the Quest for Quality,” written by editor in chief Anna Maria di Giorgio, said it well: Collaboration is a strength, and “ISPE members are its ambassadors.” Therein...
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The global nature of the supply chain has meant that pharmaceutical manufacturers have to adhere to a hodgepodge of regulations in the diverse regions in which they operate. Efforts to harmonize standards and inspection procedures between countries...
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William Fenical is frustrated that the pharmaceutical industry hasn’t developed new antibiotics for more than 20 years. Without them, it will be impossible to check the surge of superbugs—antibiotic-resistant infectious agents such as...
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A new year typically begets resolutions and the promise of change from most people. The promise of hope, really. Industry does the same, as well, albeit under different monikers—better drugs, better access for patients, better facilities, and stronger...