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Backing Biosimilars - ISPE Pharmaceutical Engineering
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Backing Biosimilars
Initially, the American College of Rheumatology urged caution around the use of biosimilars. Information about the manufacturing process for a branded biologic is proprietary; a biosimilar manufacturer will not have access to the details of the process, so how could they guarantee their product...
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The “F” Word: How Failure Leads to Success
From the time when we were young, we have been taught to avoid failure. You are told to get the best grades in school, which will lead to getting into college. And when you graduate, you’ll get a good job, work hard, and the promotions will come. At no point did anyone ever tell us to fail! But...
Women in Pharma Roundtable Session - ISPE Pharmaceutical Engineering
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Challenges, Strategies, & Successes at Women in Pharma Roundtable Session
Six women shared stories about building their diverse pharmaceutical industry careers, including challenges encountered along the way and their recommendations for other women in the profession, during a roundtable session on Women in Pharma®. The Roundtable opened the second day of the 2018 ISPE...
Millilis Family banner - ISPE Pharmaceutical Engineering
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Family Ties: Meet the Millilis
Many members think of ISPE as a family of professionals, colleagues, and friends. Two of ISPE’s active members, George and Peter Millili, have taken this a step further; they’ve made ISPE part of their family.
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The Medium and the Message
Teamwork and collaboration are becoming increasingly critical in today’s professional arena. The drive to produce innovative, disruptive products calls for interdisciplinary teams. To function effectively, these diverse groups require creative problem-solving, conflict resolution, and interpersonal...
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How to Start Managing Expectations
I have always held myself to a high standard and kept high expectations for myself. I always thought that setting this high bar for myself would push me harder, make me better, and ultimately help me succeed. However, when I didn’t meet the expectations that I had set, I was so hard on myself. I...
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ISPE Ireland Affiliate: 30 Years & Growing
It is an exciting time for the pharmaceutical and life sciences industries in Ireland. The country has firmly established itself as one of the world’s centers of excellence and the number one European location for pharmaceutical and life science investment. It is equally exciting for ISPE’s Ireland...
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Message from the Chair: ISPE & Information Sharing
I hope 2019 is bringing exciting challenges and fulfillment to your personal and career goals. Like 2018, 2019 will have its uncertainties and opportunities but our industry will continue to evolve to bring new life-saving therapies to patients around...
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Teamwork Unlocks Success - Lessons from the Lacrosse Field
Across industries, the trend is toward speed to market. - Whether it’s meeting consumer expectations for instant service or being the first to bring an innovation to shelves, companies have plenty of incentives to make products and services available faster.
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Fishing for Biopharma Success
Maritime discipline took the Boston Area Chapter President from a trawler to the boardroom. - It might seem odd to connect commercial fishing to the study of chemical engineering— and perhaps even more unlikely to connect commercial fishing to a career in the biopharmaceutical industry. But for...
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A New Year Begins for Young Professionals in 2019
Happy 2019! The last time I saw many of you was at the ISPE 2018 Annual Meeting & Expo in Philadelphia, where I started my tenure as the ISPE International Young Professionals Chair.
ISPE 2018 Annual Meeting Banner - ISPE Pharmaceutical Engineering
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Vision to Reality: 2018 ISPE Annual Meeting & Expo Highlights
Over 2,000 attendees from more than 28 countries gathered in Philadelphia for the 2018 ISPE Annual Meeting & Expo on 4–7 November. Highlights below show the many ways that presenters captured the conference theme of “Vision to Reality”: in strides against disease, ISPE’s advancements over the last...
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ISPE’s New Year: Our Story in Action
On sitting down to write my first Chair’s column, I reflected on the events at our Annual Meeting & Expo in November. First, I want to commend the entire ISPE organization, and offer particular thanks to the 2018 Annual Meeting planning committee, for...
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Just so You Know Info from This Issue
JSYK: JUST SO YOU KNOW Info from this issue 50% Percentage of FDA Warning Letters that cite data integrity issues, 2017–Q1 2018 Data Integrity 40% - 50% RFT error rate for paper-based laboratory records 15% - 25% How much...
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Aeration Equipment in Aerobic Fermentation Processes
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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From Concepts to Reality - Meet Young Professional Richi Sethi
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 Quality & Consortia - 2018 Continuous Manufacturing Workshop Recap
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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Welcome to the New Pharmaceutical Engineering Online
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...
industry demands - ISPE Pharmaceutical Engineering
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ISPE Foundation Launch: New Ways to Address Key Pharma Industry Needs
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...
Message from the Chair - A Year of Achievements - ISPE Pharmaceutical Engineering
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A Year of Achievements
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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More Advice from the Top
My conversation with six members of ISPE's Board of Directors continues this month.
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Time Flies: A Look Back—and Ahead
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...
Preparing the Workforce of the Future - Chalkboard - ISPE Pharmaceutical Engineering
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Preparing the Workforce of the Future
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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Overview of the ISPE GAMP® Guide: Records & Data Integrity
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...
Evolution of the Pharmaceutical Industry - ISPE Pharmaceutical Engineering
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Evolution of the Pharmaceutical Industry
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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GAMP 5: Ten Years On
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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Job Seekers: Observations From A Career Event
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...
Article - ISPE Pharmaceutical Engineering
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Three Things That Will Change Medicine In 2018
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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Pairing Knowledge with Imagination
Imagination is more important than knowledge. Knowledge is limited. Imagination encircles the world. —Albert Einstein
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How to Develop Your Career as a Pharma Young Professional
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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ISPE Regulatory Volunteer Operations Part 2
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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Sustainability and the Way Forward
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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First Quarter Update
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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The Value of Travel, The Benefits of Diversity
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 been an...
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Young Professionals Workshop: A Strategic 4.0 Road Map
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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ISPE Europe Pharma 4.0 Conference: A First-Person Report
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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To Temp or Not to Temp?
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...
EMA Moves to Amsterdam - ISPE Pharmaceutical Engineering
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European Medicines Agency (EMA) Moves to Amsterdam
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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Tapping the Network: Meet Young Professional Thorsten Böhle
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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A New Year, A New Dawn
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...
Italian Biopharma (Infographic) - ISPE Pharmaceutical Engineering
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Italian Biopharma
$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 2010,...
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Creating Member Value Through Innovation
  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 come...
ISPE Pharmaceutical Engineering - ISPE Pharmaceutical Engineering
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Medical Ethics: Conflicting Obligations
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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Using Social Media in Your Job Search
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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Transitions Our Members & Pharma Industry are Making
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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Microbiome Treatments for Recurrent C. Difficile Infections
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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Heroes Make Us Strong
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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The New Normal in the Pharma Industry
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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Acing the Photo Interview
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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Tips for Graduates Transitioning to Pharma Industry
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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Great Lakes Chapter Brings Training & Information to Midwest
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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New Technology, Ambition, & Patient Safety
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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Epigenetics in Diseases of Aging
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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Advancing Innovative Technologies
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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Diabetes and the Internet of Things
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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Mastering the Art of Supply Chain Management
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 levels,...
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Matthew Kennedy on Disruptive Innovation
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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ISPE Italy Affiliate Poised for Leadership
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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26th Annual ISPE Aseptic Conference
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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My First Year as a Consulting Engineer
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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What is "Industry 4.0" & Are We Ready for It?
“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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ISPE Strategic Plan Update
"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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Compliance & Sustainability: Conflict or Harmony?
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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Perseverance & Grit: Effort Counts Twice
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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Partnerships: A Potential Game Changer
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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Regulatory Changes Affecting Pharma Supply Chain
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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Where will New Antibodies Come From?
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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The Promise of Hope
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...