Featured Articles

Features
Article of the Year 2018 Winner: The winner of the 2018 Roger F. Sherwood Article of the Year award is “Continuous Manufacturing in Biotech Processes: Challenges for Implementation” by Robert Dream, PE, CPIP; Christoph Herwig, PhD; and Emilie...
Features
Moving platforms from development to the delivery of more biopharmaceuticals to more patients is reality, not just a concept, for Moderna, Inc. Juan Andres, the company’s Chief Technical Operations and Quality Officer, presented on “mRNA Medicines—Industrializing a New Platform” at the 2019 ISPE...
Features
The US FDA Center for Devices and Radiological Health (CDRH) Case for Quality program promotes a risk-based, product quality–focused, and patient-centric approach to computerized systems. This approach encourages critical thinking based on product and process knowledge and quality risk management...
Features
Presenters and a panel of FDA regulators and industry experts discussed key regulatory and industry issues during the closing plenary of the 2019 ISPE Biopharmaceutical Manufacturing Conference .
Features
Innovation has been and continues to be a driver for the strides being made in biopharma development and manufacturing, noted Eric S. Langer, President and Managing Partner, BioPlan Associates, Inc., who addressed “Innovation in Transformative...
Features
Cell and gene therapies are the latest revolution in medicine manufacturing. Unlike small molecules or traditional biotech products, these therapies introduce cells and genes into a patient to treat the underlying cause of a disease—they are living medicines.
Features
Innovations in production methods and technologies that enable a competitive and sustainable biopharmaceutical product supply were the focus of presentations at the 2019 ISPE Biopharmaceutical Manufacturing Conference in Boston, Massachusetts, 18–20 June. Future directions for the biopharma...
Special Reports
The 2019 ISPE Annual Meeting & Expo will be held 27–30 October in Las Vegas, Nevada. The theme is “Modernize. Globalize. Transform.” Michael L. Rutherford, Program Committee Chair and Board Ambassador for ISPE, and Executive Director for Computer Systems Quality and Data Integrity at Syneos Health,...
Features
On 5 June 2018, a plenary session entitled ”Patient-Centric Specification” (PCS) was held at the 2018 ISPE Quality Manufacturing Conference in Arlington, Virginia. More than 160 professionals from worldwide innovator and generic pharmaceutical companies, academia, and regulatory agencies attended....
Features
The Pharma 4.0 Special Interest Group is focusing on key technologies that will modernize pharmaceutical manufacturing and facilitate digital transformation. These technologies include digital twins, augmented reality, artificial intelligence, big data and analytics, mobiles, cloud, advanced...
Features
To facilitate the assessment and mitigation of compliance risks associated with a third-party service organization, its services, and the systems used to provide the services, this article proposes adopting an approach from the financial sector that, with a little modification, could be used to...
Features
To meet the EU serialization deadline on 9 February 2019, pharmaceutical companies and their contractors have had to reorganize their manufacturing lines and logistics to ensure compliance with the EU’s Falsified Medicines Directive (FMD) of 2011 and the EU Commission Delegated Regulation 2016/161...
Features
Continuous manufacturing (CM) is an advancement in pharmaceutical manufacturing technology that provides high assurance of product quality as well as enough flexibility and agility in production to respond to market demands. The decision to invest in CM can be challenging for a company given the...
Features
The 2018 ISPE Biopharmaceutical Manufacturing Conference on 10–12 December in Huntington Beach, California, provided information about future-oriented developments in the burgeoning area of biopharmaceutical manufacturing—and also shared insights into the achievements that are already underway....
Features
This article examines patient preferences in one facet of clinical research: the experience related to the use of investigational medicinal products (IMPs). As patients have become more involved and informed in their healthcare choices, the “voice of the patient” has been increasingly incorporated...
Features
It is the duty of the government to improve access to safe, effective, and quality medicines for its constituents. Various approaches are taken by different countries to achieve this; for the Philippines, the approach is through the active promotion of...
Features
In Japan, off-patented drugs are not always converted to generic drugs but may remain on the drug list as off-patented-drug products. These are customarily classified into three groups: patented drugs; off-patented drugs (“long-listed drugs”); and...
Features
Data is an important factor that is reshaping the pharmaceutical industry and triggering significant innovation. Vertical integration of equipment can represent an optimal solution to manage the increasing flow of data efficiently, innovate the manufacturing environment, and fulfill data integrity...
Features
The 2018 ISPE Quality Manufacturing Conference , held 4–6 June 2018 in Arlington, Virginia, included a well-attended session entitled “Data Integrity—Beyond the Lab,” which reaffirmed continued focus from both industry and regulators on this critical element of assuring product quality and patient...

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Latest Articles

iSpeak Blog
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from November 2019. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last...
iSpeak Blog
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from November 2019. Discover key insights for cleaning validation practices, risk-based approaches to quality, and more for what the pharmaceutical industry was reading last...
iSpeak Blog
The formal announcement and certification of the ISPE Mexico Affiliate took place at the recent 2019 ISPE Annual Meeting & Expo in Las Vegas, Nevada on Tuesday, October 29. The creation of the ISPE Mexico Affiliate was promoted by a group of enthusiastic...
On Wednesday, 4 December 2019, ISPE held its first-ever Executive Forum focused on Workforce of the Future issues impacting the pharmaceutical industry.  The Forum was an important milestone in the broader Workforce of the Future initiative being led by...
iSpeak Blog
Recap of the Opening Plenary Session of the 2019 ISPE Global Pharmaceutical Regulatory Summit Industry and regulators came together on 5-6 December for the 2019 ISPE Global Pharmaceutical Regulatory Summit in North Bethesda, Md. Regulators were both...
iSpeak Blog
Philippe Fournet-Fayard Vice-President ISPE Mexico Affiliate The newly established ISPE Affiliate in Mexico is led by a group of 14 professionals, with...
iSpeak Blog
Costs of pharmaceuticals to the American consumer and healthcare systems are immense, so immense in fact that Senators are calling for new actions to address the high cost of prescription drugs in America. The US spent 345 billion USD on prescription...
iSpeak Blog
Featured in this edition of iSpeak Reading Roundup, are the top blog posts from October 2019. See leading facilities, break-through therapies, innovative technologies, and more for what the pharmaceutical industry was reading in October. Benefits of...
iSpeak Blog
Raise your hand if you often speak before you think. If this is you (as it’s often me), I encourage you to slow down and consider your words carefully. What we say in conversation and presentation speaks volumes about our level of confidence and how we...
iSpeak Blog
Background As part of the Case for Quality program US FDA CDRH (Center for Devices and Radiological Health) have identified that an excessive focus on compliance rather than quality may divert resources and management attention towards meeting...
iSpeak Blog
The pharmaceutical industry’s ability to evolve alongside innovations in technology and science increases with the incorporation of digital systems and redesigned data collectors. Pharma 4.0™ is a trending industry initiative that highlights the impact...
InTouch
What Does the Industry Want and Need? Eric S. Langer, President and Managing Partner, BioPlan Associates, Inc., shared these most-needed cell and gene therapy manufacturing improvement, systems, platforms, and infrastructure from his company’s...
Technical
The internet has led to an increase in e-commerce of prescription and over-the-counter (OTC) medicinal products; one in four adults has purchased medicines online. 1 , 2 This expansion of e-commerce in pharmaceuticals has greatly improved many companies’ bottom lines. For example, in 2017, the...
InTouch
Eric J. Staib Vice President of Compliance Genpact ISPE’s newest Special Interest Group (SIG) will work on the emerging areas of artificial intelligence (AI) and machine learning (ML). The Artificial Intelligence Special Interest Group was formed under GAMP®. A conversation with Eric Staib, Vice...
Technical
Cleanrooms and laboratories can save a significant amount of energy by reducing airflow of air handling units (AHUs) after closing hours. Although challenging, airflow reduction is a successful energy reduction measure and has been implemented within the energy reduction program of Janssen Vaccines...
Insights
Tracy L. Clemmer’s experience has spanned the globe, and she has an impressive list of ISPE roles on her résumé. In addition to being a past President and Chair of the Training and Education Committee of the ISPE Singapore Affiliate , she was a Board Member and Chair of the Training and Education...
Insights
I was recently meeting with one of the individuals I am lucky enough to call a mentor and friend. During our dinner, we talked about various topics from general life items to questions about work. One of the questions she asked that inspired me to write this article was, “If leaders are people with...
Insights
The November-December issue of Pharmaceutical Engineering is published in the months of the Thanksgiving holiday in the US and the year-end holidays celebrated around the world, so it seems appropriate to note the many changes to the magazine this year and give thanks to those who have contributed...
iSpeak Blog
Jennifer Lauria Clark, CPIP Executive Director, Strategic Development CAI Jennifer Lauria Clark joined ISPE as a college student, and since then, has...
Day 3 Recap: 2019 ISPE Annual Meeting & Expo The Membership and Awards Breakfast on Tuesday 29 October at the 2019 ISPE Annual Meeting & Expo saw a number of ISPE members honored with awards, a report on the state of the Society, and new ISPE...
This morning I passed the gavel and ended my time as Chairman of the International Society of Pharmaceutical Engineering (ISPE) Board of Directors. ISPE is a GREAT professional society that represents 18,500+ Members around the world in 65+ countries,...

Current Issue

November / December 2019

Cell and Gene Therapies and Their GMP Requirements Cover: Cell and gene therapies are the latest revolution in medicine manufacturing. Unlike small molecules or traditional biotech products, these therapies introduce cells and genes into a patient to treat the underlying cause of a disease—they are living medicines. This article provides an overview of key considerations for manufacturers of cell...