Advancing Lean Implementation for Next Generation Biomanufacturing Operations

Advancing Lean Implementation for Next Generation Biomanufacturing Operations PDF Author: Joshua David Jensen
Publisher:
ISBN:
Category :
Languages : en
Pages : 57

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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.

Advancing Lean Implementation for Next Generation Biomanufacturing Operations

Advancing Lean Implementation for Next Generation Biomanufacturing Operations PDF Author: Joshua David Jensen
Publisher:
ISBN:
Category :
Languages : en
Pages : 57

Get Book Here

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.

3D Printing in Medicine and Surgery

3D Printing in Medicine and Surgery PDF Author: Daniel J. Thomas
Publisher: Woodhead Publishing
ISBN: 0081025432
Category : Technology & Engineering
Languages : en
Pages : 306

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Book Description
3D Printing in Medicine and Surgery: Applications in Healthcare is an advanced book on surgical and enhanced medical applications that can be achieved with 3D printing. It is an essential handbook for medical practitioners, giving access to a range of practical methods, while also focusing on applied knowledge. This comprehensive resource features practical experiments and processes for preparing 3D printable materials. Early chapters cover foundational knowledge and background reading, while later chapters discuss and review the current technologies used to engineer specific tissue types, experiments and methods, medical approaches and the challenges that lie ahead for future research. The book is an indispensable reference guide to the various methods used by current medical practitioners working at the forefront of 3D printing applications in medicine. Provides a detailed introduction and narrative on how 3-D printing can be used towards developing future medicine-based therapies Covers up-to-date methods across a range of application areas for the first time in book form Presents the only book on all current areas of 3D printing in medicine that is catered to a medical rather than engineering audience

Continuous Biomanufacturing

Continuous Biomanufacturing PDF Author: Ganapathy Subramanian
Publisher: John Wiley & Sons
ISBN: 3527340637
Category : Science
Languages : en
Pages : 628

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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.

Product Lifecycle Management: Driving the Next Generation of Lean Thinking

Product Lifecycle Management: Driving the Next Generation of Lean Thinking PDF Author: Michael Grieves
Publisher: McGraw Hill Professional
ISBN: 0071786309
Category : Business & Economics
Languages : en
Pages : 336

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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.

Transdex Index

Transdex Index PDF Author:
Publisher:
ISBN:
Category : Translations
Languages : en
Pages : 174

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Book Description
An index to translations issued by the United States Joint Publications Research Service (JPRS).

Intersections Between Rights and Technology

Intersections Between Rights and Technology PDF Author: Anand, Amit
Publisher: IGI Global
ISBN:
Category : Science
Languages : en
Pages : 469

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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.

Biotechnology Entrepreneurship

Biotechnology Entrepreneurship PDF Author: Craig Shimasaki
Publisher: Academic Press
ISBN: 0128155868
Category : Reference
Languages : en
Pages : 684

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Book Description
This second edition of Biotechnology Entrepreneurship: Leading, Managing, and Commercializing Innovative Technologies is an authoritative, easy-to-read guide covering biotechnology entrepreneurship and the process of commercializing innovative biotechnology products. This best practice resource is for professional training programs, individuals starting a biotech venture, and for managers and experienced practitioners leading biotech enterprises. It is a valuable resource for those working at any level in the biotech industry, and for professionals who support and provide essential resources and services to the biotech industry. This practical, “how-to book is written by seasoned veterans experienced in each of the operational functions essential for starting, managing, and leading a successful biotech company.Biotechnology Entrepreneurship explains the biotech business components and underlying strategies, interspersed with practical lessons from successful biotech entrepreneurs, educators, and experienced practitioners. These veteran contributors share their insights on how to be successful in this challenging but exciting industry. Subjects range from technology licensing and translating an idea into a viable business, forming your legal company entity, securing angel and venture capital, navigating product development, FDA regulatory approval, and biomanufacturing.This book is a user-friendly guide to decision-making and overall strategy written as a hands-on management tool for leaders and managers of these dynamic biotechnology ventures. If you are contemplating starting a biotech company, are a manager at any level, a seasoned veteran, or service provider in the biotech industry, this book is a “must read. This second edition includes several new chapters on topics such as: What you need to know about valuation and term sheets Investor presentations and what you need in a biotech investor pitch deck Mentorship and why you need mentors Artificial intelligence applications in biotech and pharma Common biotech entrepreneur mistakes and how to avoid them

Process Control, Intensification, and Digitalisation in Continuous Biomanufacturing

Process Control, Intensification, and Digitalisation in Continuous Biomanufacturing PDF Author: Ganapathy Subramanian
Publisher: John Wiley & Sons
ISBN: 3527347690
Category : Technology & Engineering
Languages : en
Pages : 404

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Book Description
Process Control, Intensification, and Digitalisation in Continuous Biomanufacturing Explore new trends in continuous biomanufacturing with contributions from leading practitioners in the field With the increasingly widespread acceptance and investment in the ??technology, the last decade has demonstrated the utility of continuous ??processing in the pharmaceutical industry. In Process Control, Intensification, and Digitalisation in Continuous Biomanufacturing, distinguished biotechnologist Dr. Ganapathy Subramanian delivers a comprehensive exploration of the potential of the continuous processing of biological products and discussions of future directions in advancing continuous processing to meet new challenges and demands in the manufacture of therapeutic products. A stand-alone follow-up to the editor’s Continuous Biomanufacturing: Innovative Technologies and Methods published in 2017, this new edited volume focuses on critical aspects of process intensification, process control, and the digital transformation of biopharmaceutical processes. In addition to topics like the use of multivariant data analysis, regulatory concerns, and automation processes, the book also includes: Thorough introductions to capacitance sensors to control feeding strategies and the continuous production of viral vaccines Comprehensive explorations of strategies for the continuous upstream processing of induced microbial systems Practical discussions of preparative hydrophobic interaction chromatography and the design of modern protein-A-resins for continuous biomanufacturing In-depth examinations of bioprocess intensification approaches and the benefits of single use for process intensification Perfect for biotechnologists, bioengineers, pharmaceutical engineers, and process engineers, Process Control, Intensification, and Digitalisation in Continuous Biomanufacturing is also an indispensable resource for chemical engineers seeking a one-stop reference on continuous biomanufacturing.

Early Implementation of Generation I of the Workforce Innovation in Regional Economic Development (WIRED) Initiative

Early Implementation of Generation I of the Workforce Innovation in Regional Economic Development (WIRED) Initiative PDF Author:
Publisher:
ISBN:
Category : Economic development
Languages : en
Pages : 240

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Book Description


Serial Innovators

Serial Innovators PDF Author: Abbie Griffin
Publisher: Stanford University Press
ISBN: 0804783322
Category : Business & Economics
Languages : en
Pages : 238

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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.