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Reporting categories for changes in the drug substance (DS) and drug product (DP) process and analytical methods per FDA guidance [
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Case Study: Facilitating Efficient Life-Cycle Management via ICH Q12
The latest ICH guideline, ICH Q12,International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. “ICH Harmonised Guideline: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management. Q12. Final Version.” 20 November 2019....
Achieving Vertical & Horizontal Integration in Pharma 4.0™
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Achieving Vertical & Horizontal Integration in Pharma 4.0™
Recent projects on serialization and track and trace help illustrate the concepts of vertical and horizontal integration. With vertical integration, the unique product identification information (serial number, lot, etc.) used by sensors and printers on the packaging lines is made accessible to the...
Regulatory Panel Session: Explores Key Aseptic Topics
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Regulatory Panel Session: Explores Key Aseptic Topics
The 2020 ISPE Aseptic Conference was capped off on Tuesday, 3 March, by the Interactive Regulatory Panel session, which has been a popular feature of the conference during its 29 years. The session featured a panel of seven US FDA regulators who addressed a long and varied list of questions about...
Tracking the Journey of Barrier Technology
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2020 ISPE Barrier Survey: Tracking the Journey of Barrier Technology
For over two decades, the ISPE Barrier Isolator Survey has gathered meaningful data on the applications of barrier technology and been a resource for the fill-finish pharmaceutical industry community. This article provides context for the latest survey, the first in several years, and presents its...
Sustainability & the Life Sciences Industry: A Global Introduction cover
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Sustainability & the Life Sciences Industry: A Global Introduction
In this issue of Pharmaceutical Engineering®, we address an array of sustainability topics. This article surveys topics that will likely have a significant global impact on the way we conduct our business over the coming decade. We trace some history of sustainability in the life sciences industry...
Wearable Devices & Biometrics Improving Efficiency in GxP Operations
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Wearable Devices & Biometrics Improving Efficiency in GxP Operations
As the old saying goes, “Time is money.” In today’s industrialized world, this adage is profoundly true. Manufacturers can no longer afford to overlook operational excellence. A new production philosophy called “Lean manufacturing” has been developed to save as much time as possible during...
Regulators Address Innovations & Harmonization
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Regulators Address Innovations & Harmonization
At the 2019 ISPE Global Pharmaceutical Regulatory Summit, regulators updated attendees on approaches to industry innovations and the ongoing work on harmonization and reliance around the world.
Update from the ISPE Regulatory Steering Council
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Update from the ISPE Regulatory Steering Council
Virtually every ISPE member has at least one story to tell about how health authority inspections or the review and approval of regulatory applications have affected their efforts to supply critically needed medications to patients globally. Although these stories may emphasize the considerable...
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ISPE Comments to the Annex 2 PIC/S Draft Revision
Annex 2 is the Good Manufacturing Practices (GMP) document by the Pharmaceutical Inspection Co-operation Scheme (PIC/S) addressing manufacture of biological medicinal substances and products for human use. This article shares information about Annex 2 and ISPE’s submitted comments to the draft...
ICH Q12: A Transformational Product Life-Cycle Management Guideline
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ICH Q12: A Transformational Product Life-Cycle Management Guideline
On 20 November 2019, the ICH Assembly endorsed the Q12 guideline, “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management,” at its biannual meeting in Singapore. This transformational guideline has a wide scope of applicability across pharmaceutical drug substances...
A Gamp® Approach to Robotic Process Automation
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A GAMP® Approach to Robotic Process Automation
This article introduces the concept of robotic process automation (RPA) and discusses how the technology may be used within a GAMP® framework to support both non-GxP and GxP processes.
Sustainability & the Life Sciences Industry: A Global Introduction cover
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Sustainability & the Life Sciences Industry: A Global Introduction
In this issue of Pharmaceutical Engineering®, we address an array of sustainability topics. This article surveys topics that will likely have a significant global impact on the way we conduct our business over the coming decade. We trace some history of sustainability in the life sciences industry...
Company A energy audit summary (annual carbon savings by utility category).
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Two Real-World Experiences in Global Sustainability
The article appraises the real-world experiences of two pharmaceutical companies approaching the rollout of energy- and water-reduction programs to selected facilities around the world. It is the result of more than two years of collaboration between the company corporate teams, individual site...
Figure 2: Energy Venn diagram (per I.S. 399) and filter dryer example.
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Implementation of a Formal Energy-Efficient Design Process
Sustainability is a key principle for pharmaceutical companies in 2020. However, translating corporate goals into meaningful improvements can be a challenge, particularly when competing factors such as complex technical requirements or ambitious project schedules are involved.
Figure 1: Sources of pharmaceuticals in the environment. Adapted from reference
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Industry Perspective: Bioremediation of Pharmaceuticals
Medical treatments and pharmaceuticals are indispensable in improving quality of life. In recent years, however, pharmaceutical compounds have become a significant group of environmental pollutants, shown to pose risks to human health and have adverse environmental effects.
Introducing Industry Leaders
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Introducing Industry Leader Profile Articles
With the start of the new year, Pharmaceutical Engineering® is launching a new series of profiles of industry leaders. This ongoing series will look at the lives and careers of individuals who are changing the face of the pharmaceutical industry.
Industry Leaders: An Advocate for Quality - Ranjana B. Pathak
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Industry Leaders: An Advocate for Quality
Ranjana B. Pathak, BSc (Hons), MBA, DHA, has spent nearly 40 years in the pharmaceutical industry. Currently the President and Global Head of Quality, Medical Affairs, and Pharmacovigilance at Cipla Ltd. in Mumbai, India, Pathak’s long tenure has afforded her an informed perspective on the past,...
Industry Leaders: Bringing Pharma 4.0™ Into the World - Christian Wölbeling
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Industry Leaders: Bringing Pharma 4.0™ Into the World
Every important cause needs its champion. Champions have a vision of how things should be, and a passion to reach their goals. They are committed and determined to achieve positive results, are willing to do the heavy lifting, and will take consistent and massive action until results are achieved.
Biotech Industry’s Quest for Optimized Manufacturing Facility Design
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Biotech Industry’s Quest for Optimized Manufacturing Facility Design
Since the early 1990s, when the “upstart” biotech industry realized that its future success would be heavily influenced by the ability to manufacture multiple products within the same facility,Hill, D., and M. Beatrice. “Biotechnology Facility Requirements, Part 1, Facility and Systems Design.”...
Figure 2: ISPE Pharma 4.0™ operating model
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Applying Holistic Control Strategy in Pharma 4.0™
Applying emerging technologies can lead to more robust and flexible manufacturing processes that in turn can help the pharmaceutical industry respond to drug shortages, reduce interruptions in production and delivery of medicines, ensure consistent clinical performance of products, and achieve...
Figure 2: Steps in a holistic cleanroom concept.
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A Holistic Cleanroom Concept: Higher Quality & Greater Flexibility
As the pharmaceutical industry balances demands for small-batch and blockbuster products and encounters new regulations, there is a need for efficient and safe production technologies that can meet stringent quality and safety requirements for the aseptic filling of drugs. Looking forward,...
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Continuous Manufacturing in Biotech Processes
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...
Industrializing New Platforms
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Industrializing New Platforms
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...
Why ISPE GAMP® Supports the FDA CDRH: Case for Quality Program
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Why ISPE GAMP® Supports the FDA CDRH: Case for Quality Program
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...
Practical Regulatory and Industry Panel
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Practical Regulatory & Industry Issues
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.
Eric S. Langer
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Biopharma Growth Trends: More Innovation on the Way
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...
Cell and Gene Therapies and Their GMP Requirements
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Cell and Gene Therapies & Their GMP Requirements
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.
2019 ISPE Biopharmaceutical Manufacturing Conference
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The Next Wave in Biopharma Manufacturing
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...
Risk Management in Single-Use Technology
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Risk Management in Single-Use Technology
Risk management is pervasive throughout the biopharmaceutical industry. It is an important factor during the implementation of new equipment or procedures into an operation. Likewise, risk management is also key when assessing the impact of changes. When doing a root cause analysis, evaluation of...
Patient-Centric Specification: Regulatory and Industry Progress
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Patient-Centric Specification: Regulatory & Pharma Industry Progress
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....
Digital representation of a chemical API process
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The Digital Twin: Creating Efficiencies in a Virtual World
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...
Application of SOC 2+ Process to Assessment of GxP Suppliers of Services
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Application of SOC 2+ Process to Assessment of GxP Suppliers of Services
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...
Improving Pharmaceutical Connections with Patients cover
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Improving Pharmaceutical Connections with Patients
Being on the cutting edge of drug development is the goal of most pharmaceutical companies, but a new drug won’t work if the patient doesn’t take it. It’s a vexing problem that developers of healthcare technologies hope to address.
Holistic Control Strategies for Continuous Manufacturing
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Holistic Control Strategies for Continuous Manufacturing
Innovative technologies such as continuous manufacturing (CM) bring speed, efficiency, and agility to pharmaceutical manufacturing together with enhanced process robustness and assurance of product quality. During CM, material is simultaneously charged and discharged into process unit operations....
Serialization model
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Ten Frequently Asked Questions about Serialization
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...
Continuous Manufacturing cover
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Regulatory Progress - Global Advancement of Continuous Manufacturing for Pharma
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...
Biopharma Growth & Regulatory Perspectives
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Biopharma Growth & Regulatory Perspectives
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....
Identifying Global Themes in Clinical Study Participants’
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Identifying Global Themes in Clinical Study Participants’
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...
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The Philippines: Biosimilars—Opportunities & Challenges
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...
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Japan: Generics Leading Expansion
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...
Generic Drugs Banner
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China: Pursuing Quality for Generics & Biosimilars
Over the past several years, Chinese regulatory authorities have signaled an increased awareness of the need to improve quality standards for both generic and biosimilar drugs. In 2015, the China Food and Drug Administration (CFDA) (now NMPA, National...
Generic Drugs Banner
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India: From Generics to Biosimilars
India has become a major producer of generics drugs and is now the largest exporter of generics in the world.1 These exports go to over 160 countries, including the United States, Australia, Russia, and nations in Asia, the Middle East, Africa, and Latin...
Data Integrity: A Vertical Journey Banner
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Data Integrity: A Vertical Journey
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...
Data Integrity: Beyond the Lab Banner
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Data Integrity: Beyond the Lab
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...
Data Integrity in the Trenches: A Look into Quality Control Lab
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Data Integrity in the Trenches: A Look into Quality Control Lab
Pharmaceutical Engineering magazine’s March–April 2016 Special ReportInternational Society for Pharmaceutical Engineering. “Special Report: Data Integrity.” Pharmaceutical Engineering 36, no. 2 (March–April 2016): 39–67. highlighted the increasing importance of data integrity for companies...
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Eye on the Future - Janssen Expands Ireland Production Facility
Janssen is in the midst of a multimillion-dollar expansion project at the company’s Ringaskiddy, County Cork, manufacturing facility in Ireland. The 19,100-square-meter project is expected to significantly increase Janssen’s global manufacturing capacity for producing biologic medicines for...
Singapore - Biopharma’s Global Hub - ISPE Pharmaceutical Engineering Magazine
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Singapore - Biopharma’s Global Hub
Our May-June cover story on the rise of biopharmaceutical manufacturing in Asia noted that “Biopharmaceuticals are booming … buoyed by enhanced regulations, an influx of venture capital, a culture of innovation, and government support.”Fotheringham, S. “The Rise of Biopharmaceutical Manufacturing...
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A Culture of Innovation
A corporate culture that supports creative thinking can help pave a road to innovation. Free people from fear and encourage them to do their best and you’ll have an environment for accomplishing great things, according to George Scangos, who has led Biogen and other pharma companies. In a recent...
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Cm-Produced Cancer Treatment Receives FDA Approval
Eli Lilly and Company’s continuous manufacturing (CM) kits have proven to be an important manufacturing platform for the company’s oral solid dosage products (OSD). “CM is very important to Lilly as one of our proven manufacturing platforms for...
In-Line, Real-Time Powder Flow & Process Monitoring - Bottles
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In-Line, Real-Time Powder Flow & Process Monitoring
Innovative technology for in-line real-time powder flow monitoring based on drag force flow measurement offers great potential for efficient monitoring of powder-processing operations.
Digital Labels Revolutionize Investigational Medicinal Products (IMPs)
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Digital Labels Revolutionize Investigational Medicinal Products (IMPs)
Labeling is an important part of the supply chain. This is especially true for investigational medicinal products (IMPs), which must be labeled with clear expiry dates and other mandated information. IMP shelf life is notoriously difficult to quantify, however, and new findings on their stability...
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Blockchain: The Next Big Distruptor in Clinical Trials?
The digital revolution is driving change across all industries. With its ability to increase transparency and trust between parties, the recent innovation called blockchain has the potential to significantly disrupt the clinical trials industry.
The Fourth Industrial Revolution
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The Fourth Industrial Revolution
Dr. Enno de Boer says rapid, major changes are on the horizon for just about everything—including manufacturing.
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Biosimilars: Changing the Pharmaceutical Industry
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...
Supply Chains Dramatic Changes Ahead
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Pharma Supply Chains: Dramatic Changes Ahead
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...
Continuous Manufacturing Current Status
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Continuous Manufacturing Current Status
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...
The Advent of Continuous Manufacturing - ISPE Pharmaceutical Engineering
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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. One of the industry's most dramatic innovations on this front is continuous...
The Rise of Biopharmaceutical Manufacturing in Asia - ISPE Pharmaceutical Engineering
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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.Liu, A. "AstraZeneca Allies with Alibaba and...
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Think (Bio)Print
Great strides are being made in bioprinting, and the end result could revolutionize pharmaceutical development and testing.
In Conversation: Bringing the Outside In
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In Conversation: Bringing the Outside In
"When a factory is needed in the future, what could it look like, and how should we think and work differently to build it?" This is a question that Roger Connor, President, Global Manufacturing Supply, GlaxoSmithKline, considers frequently. I had the privilege of meeting him during the ISPE 2017...
Reining in Consumption for Sustainable Manufacturing
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Reining in Consumption for Sustainable Manufacturing
The word “sustainability” is both overused and abused: We hear about sustainable development in a sustainable economy that uses sustainable packaging for a sustainable future. But it’s an important concept, especially for the pharmaceutical industry as...
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Embracing Innovation
ISPE has identified facilities of the future (FOF) as a priority in its strategic plan, and is paying particular attention to helping members and corporations understand the skills they will need to advance and maintain a competitive edge. These “musts”...
Francois Sallans 2017 Member of the Year
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Francois Salláns - 2017 Member of the Year
Maxine Seales Yonker was an active ISPE member, leader, and contributor to the industry. When she lost her battle with cancer in 2005, her memory was honored with an annual award that recognizes the same commitment to service. As he announced this...
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Gen X, Millennial - The Mentoring Relationship, Step by Step
Mentoring is a hot topic these days. Do a quick Google search of the word “mentoring” and you’ll get some 95 million results. A narrower search, “mentoring an engineer,” will get you about 11 million results, or 12% of the first search. For even more...
Crossing Over to Large Molecules
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Crossing Over to Large Molecules
Improvements in genetic engineering techniques have fueled the growth of well-characterized large molecules since the 1980s. Today, revenues from the sale of biopharmaceuticals in the United States exceed $100 billion annually. Ernst & Young Global Limited (EY). "Key Dealmaking Insights," in...
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In Good Company
The success of Novartis’s CTL019 in treating relapsed or refractory pediatric ALL, including FDA approval of the company’s biologics license application, makes it the first adoptive cell therapy to reach the market. While Novartis is also seeking...
Breakthrough for Pharma Industry & Patients
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Breakthrough for Pharma Industry & Patients - FDA Approved Gene Transfer Therapy
On 30 August, the US Food and Drug Administration (FDA) approved Novartis's Kymriah (tisagenlecleucel, CTL019), the first gene therapy for the treatment of pediatric and young-adult patients with relapsed and refractory B-cell acute lymphoblastic leukemia (ALL). Kymriah belongs to a class of drugs...
Patent Battles in the Age of Crispr
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Patent Battles in the Age of Crispr
The CRISPR/Cas9 system (CRISPR) developed for gene editing only a few short years ago* has already revolutionized genomic engineering, and clinical trials for targeted cancer therapies have recently commenced in China and the United States. CRISPR's power lies in its relative simplicity and...
Marriage of Pharma & Tech Yields Benefits for Patients
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Marriage of Pharma & Tech Yields Benefits for Patients
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...
3D Printing & Bioprinting in Pharmaceutical Manufacturing
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3D Printing & Bioprinting in Pharmaceutical Manufacturing
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...
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A Matter of Well-Being: A Profile of Anthony Maddaluna
Maintaining a robust supply of high-quality medicine is neither easy nor inexpensive. It depends on reliable processes, a secure supply chain, and a skilled workforce. Yet even when good medicines exist to treat an illness, delivery of these drugs could...
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The Growing Influence of PIC/S in Asia Pacific
The Asia Pacific region, which comprises 24 culturally diverse countries, contains 60% of the world's population and is the fastest growing region in the world today This article describes the growing influence of Pharmaceutical Inspection Co-operation Scheme (PIC/S) in the Asia Pacific region. Of...
Compliance Challenges for Global Pharmaceutical Manufacturers
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Compliance Challenges for Global Pharmaceutical Manufacturers
Amid the great opportunities that flow from extending their networks of facilities around the globe, pharmaceutical manufacturers are facing compliance challenges in emerging markets—especially culturally distinct ideas about safety, risk, and quality....
What Does 2017 Hold in Store for Pharma
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What Does 2017 Hold in Store for Pharma?
What will be the most important industry drivers, its innovations, if any? What indeed! During the ISPE 2016 Annual Meeting Pharmaceutical Engineering caught up with a few industry leaders and asked for their perspectives. Here's what they had to say.
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Drug Shortages Theory into Practice
After much focus at recent conferences and in publications on understanding the manufacturing- and quality-related causes of drug shortages, delegates at the 2016 ISPE Annual Meeting & Expo in Atlanta, Georgia, had the opportunity to hear from a panel of...
The Catastrophe of Drug Shortages in Pediatric Oncology
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The Catastrophe of Drug Shortages in Pediatric Oncology
In the 1960s, almost all children diagnosed with the most common pediatric cancer, acute lymphoblastic leukemia (ALL), were dead within 5 years. The steady and dramatic rise in survival rates since then means that today these kids have a near-90% chance...
Robin Kumoluyi
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The New Face of Leadership: Robin Kumoluyi
Three generations ago, a university degree granted admission to a well-paying 40-year career at a single company whose end point, often as not, was an engraved watch. Today, things are different. According to the US Bureau of Labor Statistics, the...
Transitioning To Multicolumn Chromatography
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Challenges & Results: Moving to Multicolumn Chromatography
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...