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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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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...
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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.” 1 While that report focused principally on China, Indonesia,...
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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.
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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...
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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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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.
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Dr. Enno de Boer says rapid, major changes are on the horizon for just about everything—including manufacturing.
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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...
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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...
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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...
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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...
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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. 1 , 2 In South Korea, biologics powerhouse...
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Great strides are being made in bioprinting, and the end result could revolutionize pharmaceutical development and testing.
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This article presents the work of the newly formed ISPE Holistic Production Control Strategy Working Group, which has identified and summarized the need for a redefined control strategy implementation methodology.
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"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...
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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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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”...
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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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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...
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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. 1 Global sales are growing at a rate of more than 8%, double the rate...
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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...
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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...
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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...
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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...
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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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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 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...
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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....
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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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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...
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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...
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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...
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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...