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Author: Joshua David Jensen Publisher: ISBN: Category : Languages : en Pages : 57
Book Description
Amgen Singapore Manufacturing (ASM) is a "first of its kind" commercial biomanufacturing site, incorporating myriad innovations including a full scale single-use bioreactor production model. Known internally at Amgen as Next Generation Biomanufacturing, this model will be the future of drug substance manufacturing at Amgen Inc. With the creation of Next Generation Biomanufacturing, significant changes are required within site operations including how Lean principles and methodologies are implemented and utilized in this model. An opportunity had been identified to determine an effective Lean implementation for ASM in order to capitalize on its full potential and set the Lean strategy for future Amgen Next Generation Biomanufacturing sites. This thesis has two primary objectives: documenting how Lean principles are deployed within a biomanufacturing operation and investigating potential opportunities for Lean within Next Generation Biomanufacturing. The first objective documents the methodology and results of the author's efforts in implementing Lean principles at ASM for Amgen while the second objective generates hypotheses on elements that will lead to more effective and efficient Lean implementation for future applications of Amgen's Next Generation Biomanufacturing model. These hypotheses were developed with qualitative research conducted within Amgen Inc. through interviews and surveys with Amgen leadership and staff. The responses from these efforts were assimilated with the use of a Grounded Theory approach and three unique hypotheses were created, summarized as: 1) Lean implementation from the start of operations, 2) Site-wide Lean implementation and 3) Technology enabled Lean implementation. Each of these hypotheses were preliminary validated through a quantitative analysis of a process improvement that involved elements of each hypothesis. The results from the process improvement showcased positive reinforcement from each of the hypotheses, with a quantifiable improvement of the process of over 70%. This thesis provides significant evidence on how biomanufacturing operations can improve the efficiency and efficacy of Lean implementations within to their organizations.
Author: Joshua David Jensen Publisher: ISBN: Category : Languages : en Pages : 57
Book Description
Amgen Singapore Manufacturing (ASM) is a "first of its kind" commercial biomanufacturing site, incorporating myriad innovations including a full scale single-use bioreactor production model. Known internally at Amgen as Next Generation Biomanufacturing, this model will be the future of drug substance manufacturing at Amgen Inc. With the creation of Next Generation Biomanufacturing, significant changes are required within site operations including how Lean principles and methodologies are implemented and utilized in this model. An opportunity had been identified to determine an effective Lean implementation for ASM in order to capitalize on its full potential and set the Lean strategy for future Amgen Next Generation Biomanufacturing sites. This thesis has two primary objectives: documenting how Lean principles are deployed within a biomanufacturing operation and investigating potential opportunities for Lean within Next Generation Biomanufacturing. The first objective documents the methodology and results of the author's efforts in implementing Lean principles at ASM for Amgen while the second objective generates hypotheses on elements that will lead to more effective and efficient Lean implementation for future applications of Amgen's Next Generation Biomanufacturing model. These hypotheses were developed with qualitative research conducted within Amgen Inc. through interviews and surveys with Amgen leadership and staff. The responses from these efforts were assimilated with the use of a Grounded Theory approach and three unique hypotheses were created, summarized as: 1) Lean implementation from the start of operations, 2) Site-wide Lean implementation and 3) Technology enabled Lean implementation. Each of these hypotheses were preliminary validated through a quantitative analysis of a process improvement that involved elements of each hypothesis. The results from the process improvement showcased positive reinforcement from each of the hypotheses, with a quantifiable improvement of the process of over 70%. This thesis provides significant evidence on how biomanufacturing operations can improve the efficiency and efficacy of Lean implementations within to their organizations.
Author: Nigel J Smart Publisher: Elsevier ISBN: 1908818409 Category : Science Languages : en Pages : 384
Book Description
With decreasing profit margins, increasing cost pressures, growing regulatory compliance concerns, mounting pressure from generic drugs and increasing anxiety about the future of healthcare reimbursement, pharmaceutical manufacturers are now forced to re-examine and re-assess the way they have been doing things. In order to sustain profitability, these companies are looking to reduce waste (of all kinds), improve efficiency and increase productivity. Many of them are taking a closer look at lean manufacturing as a way to achieve these goals. Lean biomanufacturing re-visits lean principles and then applies them sympathetically - in a highly practical approach - to the specific needs of pharmaceutical processes, which present significantly different challenges to more mainstream manufacturing processes. A major goal of the book is to highlight those problems and issues that appear more specific or unique to biopharmaceutical manufacturing situations and to provide some insights into what challenges are the important ones to solve and what techniques, tools and mechanisms to employ to be successful.Following an introduction to lean biomanufacturing, the book goes on to discuss lean technologies and methods applied in biomanufacturing. Later chapters cover the creation and implementation of the Transition Plan, issues facing the biopharmaceutical industry, creating a lean approach towards biopharmaceutical processes and the contribution of simulation models in developing these processes. The final chapter covers examples of new technology innovations which help facilitate lean biomanufacturing. - A focus on the issues associated with the application of lean principles to biomanufacturing - Practical examples of factors which can affect biopharmaceutical processes - Coverage of key factors which require integration to run an efficient biopharmaceutical process
Author: Janelle Nicole Heslop Publisher: ISBN: Category : Languages : en Pages : 99
Book Description
Amgen is one of the world's leading independent biotechnology companies and competes globally to advance important medicines in a highly competitive marketplace. Biologics manufacturers such as Amgen have traditionally invested in costly, large-scale stainless steel infrastructure to support the production of biologic medication. However, more recently, changes in the economics, such as the need to deploy less-capital intensive biomanufacturing plants faster, and advances in the technology, such as process-intensification (i.e., getting more protein from each cell), have created both incentives and pressures for smaller-scale, single-use, and modular production technologies. These incentives include greater flexibility, shorter timelines for construction / rapid deployment of new facilities, and reduced costs as well as physical and environmental footprint. To prepare for this changing business environment, Amgen must develop a manufacturing strategy that can enable the production of high quality products with significant reduction in timelines, cost, and reduced impact. To do so, Amgen is investigating a handful of these new production technologies, known as next generation manufacturing technologies, and attempting to understand their applicability in their future manufacturing model. There is a need for a transparent and standard methodology for evaluating and deploying new technologies in the manufacturing network. This study aims to address this issue and enable speed, rigor, and efficiency of decisionmaking through the use of a structured framework for selection and deployment of next generation technologies. Through literature review and engagement with Amgen experts, this study defines a next generation manufacturing technology evaluation framework. This framework involves a hybrid, multi-attribute set of metrics that are broadly categorized into economic, environmental, and operational assessment areas. The framework is then applied to assess the economic, operational, and environmental implications of deploying single use technologies in drug substance manufacturing as a test of concept. An assessment along the three areas helps to identify that single use technologies, namely single use bags due to their cost and environmental footprint, may not always be the optimum substitute for all existing process technology. Instead, a hybrid approach, mixing new single use technology with existing stainless steel infrastructure, may help to reduce variable cost and carbon footprint of the process. When the framework and this proposed hybrid approach was at an Amgen site, a potential savings of up to $ 1 M per year was identified as well as the elimination of up to thousands of liters in clean water losses, and up to 400x reduction in the carbon footprint of the process. Lastly, the assessment framework is applied as a management tool in the assessment of next generation drug product filling technology to demonstrate how the framework can be used to enable rapid decision-making related to future manufacturing scenarios.
Author: Jeff Elton Publisher: John Wiley & Sons ISBN: 111917189X Category : Business & Economics Languages : en Pages : 292
Book Description
“During a time of tremendous change and uncertainty, Healthcare Disrupted gives executives a framework and language to determine how they will evolve their products, services, and strategies to flourish in a increasingly value-based healthcare system. Using a powerful mix of real world examples and unanswered questions, Elton and O’Riordan lead you to see that ‘no action’ is not an option—and push you to answer the most important question: ‘What is your role in this digitally driven change and how can your firm can gain competitive advantage and lead?’”—David Epstein, Division Head, Novartis Pharmaceuticals “Healthcare Disrupted is an inspirational call-to-action for everyone associated with healthcare, especially the innovators who will develop the next generation of therapeutics, diagnostics, and devices.”—Bob Horvitz, Ph.D., David H. Koch Professor of Biology, MIT; Nobel Prize in Physiology or Medicine “In a time of dizzying change across all fronts: from biology, to delivery, to the use of big data, Health Disrupted captures the impact of these forces and thoughtfully develops new approaches to value creation in the healthcare industry. A must-read for those who strive to capitalize on change and reinvent the industry.”—Deborah Dunsire, M.D., president and CEO, FORUM Pharmaceuticals Healthcare at a Crossroad: Seismic Shifts, New Business Models for Success Healthcare Disrupted is an in-depth look at the disruptive forces driving change in the the healthcare industry and provides guide for defining new operating and business models in response to these profound changes. Based on original research conducted by Accenture and years of experience working with the most successful companies in the industry, healthcare experts Jeff Elton and Anne O’Riordan provide an informed, insightful view of the state of the industry, what's to come, and new emerging business models for life sciences companies play a different role from the past in to driving superior outcomes for patients and playing a bigger role in creating greater value for healthcare overall. Their book explains how critical global healthcare trends are challenging legacy strategies and business models, and examines why historical leaders in the industy must evolve, to stay relevant and compete with new entrants. Healthcare Disrupted captures this pivotal point in time to give executives and senior managers across pharmaceutical, biopharmaceutical, medical device, medical diagnostics, digital technology, and health services companies an opportunity to step back and consider the changing landscape. This book gives companies options for how to adapt and stay relevant and outlines four new business models that can drive sustainable growth and performance. It demonstrates how real-world data (from Electronic Medical Records, health wearables, Internet of Things, digital media, social media, and other sources) is combining with scalable technologies and advanced analytics to fundamentally change how and where healthcare is delivered, bridging to the health of populations, and broadening the resposibility for both. It reveals how this shift in healthcare delivery will significantly improve patient outcomes and the value health systems realize.
Author: Ganapathy Subramanian Publisher: John Wiley & Sons ISBN: 3527340637 Category : Science Languages : en Pages : 628
Book Description
This is the most comprehensive treatise of this topic available, providing invaluable information on the technological and economic benefits to be gained from implementing continuous processes in the biopharmaceutical industry. Top experts from industry and academia cover the latest technical developments in the field, describing the use of single-use technologies alongside perfusion production platforms and downstream operations. Special emphasis is given to process control and monitoring, including such topics as 'quality by design' and automation. The book is supplemented by case studies that highlight the enormous potential of continuous manufacturing for biopharmaceutical production facilities.
Author: Michael Grieves Publisher: McGraw Hill Professional ISBN: 0071786309 Category : Business & Economics Languages : en Pages : 336
Book Description
Product Lifecycle Management (PLM) is the newest wave in productivity. This revolutionary approach is an outcome of lean thinking; however, PLM eliminates waste and efficiency across all aspects of a product's life--from design to deployment--not just in its manufacture. By using people, product information, processes, and technology to reduce wasted time, energy, and material across an organization and into the supply chain, PLM drives the next generation of lean thinking. Now PLM pioneer Michael Grieves offers everyone from Six Sigma and lean practitioners to supply chain managers, product developers, and consultants a proven framework for adopting this information-driven approach. Product Lifecycle Management shows you how to greatly enhance your firm's productivity by integrating the efforts of your entire organization. Most companies are seeing the returns of their efforts in lean methods diminishing, as the most fruitful applications have already been addressed. Here, Grieves reveals how PLM gives you an opportunity to make improvements both within and across functional areas in order to increase agility, optimize efficiency, and reduce costs across the board. He gives you the most comprehensive view of PLM available, fully outlining its characteristics, method, and tools and helping you assess your organizational readiness. There's also proven examples from the field, where PLM is being widely adopted by leading companies, including General Motors, General Electric, and Dell, that are widely adopting the approach. You'll see how PLM has saved these companies billions in unnecessary costs and shaved as much as 60% off cycle times. With this book you'll learn how to: Develop and implement your PLM strategy to support your corporate objectives Engage all your employees in using information to eliminate waste Enable improved information flow Better organize and utilize your intellectual capital Foster an environment that drives PLM Lean manufacturing can only take your organization so far. To bring your productivity to the next level and save remarkable amounts of time, money, and resources, Product Lifecycle Management is your one-stop, hands-on guide to implementing this powerful methodology.
Author: Abbie Griffin Publisher: Stanford University Press ISBN: 0804783322 Category : Business & Economics Languages : en Pages : 238
Book Description
Serial Innovators: How Individuals Create and Deliver Breakthrough Innovations in Mature Firms zeros in on the cutting-edge thinkers who repeatedly create and deliver breakthrough innovations and new products in large, mature organizations. These employees are organizational powerhouses who solve consumer problems and substantially contribute to the financial value to their firms. In this pioneering study, authors Abbie Griffin, Raymond L. Price, and Bruce A. Vojak detail who these serial innovators are and how they develop novel products, ranging from salt-free seasonings to improved electronics in companies such as Alberto Culver, Hewlett-Packard, and Procter & Gamble. Based on interviews with over 50 serial innovators and an even larger pool of their co-workers, managers and human resources teams, the authors reveal key insights about how to better understand, emulate, enable, support, and manage these unique and important individuals for long-term corporate success. Interestingly, the book finds that serial innovators are instrumental both in cases where firms are aware of clear market demands, and in scenarios when companies take risks on new investments, creating a consumer need. For over 25 years, research on innovation has taken the perspective that new product development can be managed like any other (complex) process of the firm. While a highly structured and closely supervised approach is helpful in creating incremental innovations, this book finds that it is not conducive to creating breakthrough innovations. The text argues that the drive to routinize innovation has gone too far; in fact, so far as to limit many mature firms' ability to create breakthrough innovations. In today's economy, with the future of so many large firms on the line, this book is a clarion call to businesses to rethink how to nurture and thrive on their innovative workforce.
Author: Anand, Amit Publisher: IGI Global ISBN: Category : Science Languages : en Pages : 469
Book Description
Artificial Intelligence (AI) is swiftly reshaping global regulatory frameworks, and current discussions on privacy have been thrust into the limelight. The virtual spaces we inhabit and technological advancements demand reevaluating our understanding of privacy, freedom of expression, and access to information. As the world grapples with unprecedented digital transformation, intensified by the global pandemic, exploring the human impact of AI has never been more important. The book, Intersections Between Rights and Technology explores this juncture, dissecting the intricate relationship between the rights we hold dear and the transformative power of technology. This book navigates the complexities of safeguarding human rights in the digital realm with a multidisciplinary lens. Addressing issues of paramount importance—privacy, human dignity, personal safety, and non-discrimination—the book critically examines the evolving landscape and the necessity to recalibrate legal and societal norms. This book is an indispensable resource for scholars, policymakers, law enforcement professionals, and individuals passionate about shaping a digital world where rights are not just respected but actively protected.
Author: Thomas Lager Publisher: World Scientific Publishing Company ISBN: 1911299506 Category : Technology & Engineering Languages : en Pages : 382
Book Description
This book will take the reader through a systematic examination of the factors involved in process innovation. It starts with the considerations to be initiated in the boardroom and at group management level and develops into a hands-on guide for middle management and professional engineers directly involved in the innovation of process technology. The book initially puts process innovation in a corporate perspective, providing a framework for the development of a corporate process innovation strategy. Some new methodological tools are also introduced which support the targeting and proper roadmapping of improved process capabilities, and the progression of customer and end-user product demands, into raw-material specifications in a well-managed supply and demand chain.Various aspects of the design of a process innovation organisation are reviewed in a later section. In the context of the development of process technology, this book advocates the importance of delineating and clarifying corporate work processes. Various environments for development work are discussed, from initial test work to pilot-plant testing and the use of demonstration facilities to achieve lean process innovation. The importance of an open collaborative approach is stressed. This includes involving external equipment manufacturers at an early stage as well as collaborative development of customers' use of the products in their production processes, with a view to excellence in future application development.Process innovation will not, however, generate profit or reduce operating costs until the new or improved process technology is operating well in the plant. Best practice for start-up of new process technology and process plants is examined, starting with a fresh outlook on technology transfer in general. This often-neglected area of management of process innovation is, in fact, of an importance equivalent to that of a product launch in the development of new products. The final part of the book closes the circle, discussing how to implement and measure the strategic intent of process innovation. Improving the general performance of corporate process innovation is then covered by going through success factors and key performance indicators, and their aggregation on a corporate level.
Author: Joshua David Jensen
Author: Joshua David Jensen
Author: Nigel J Smart
Author: Janelle Nicole Heslop
Author: Jeff Elton
Author: Ganapathy Subramanian
Author: Michael Grieves
Author: Abbie Griffin
Author: Anand, Amit
Author: Thomas Lager
Author: