Lean Product and Process Development, 2nd Edition

Lean Product and Process Development, 2nd Edition

Author: Allen C. Ward

Publisher: Lean Enterprise Institute

Published: 2014-03-05

Total Pages: 509

ISBN-13: 1934109444

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"The P-51 Mustang—perhaps the finest piston engine fighter ever built—was designed and put into flight in just a few months. Specifications were finalized on March 15, 1940; the airfoil prototype was complete on September 9; and the aircraft made its maiden flight on October 26. Now that is a lean development process!" —Allen Ward and Durward Sobek, commenting on the development of the P-51 Mustang and its exemplary use of trade-off curves. Shingo Research and Professional Publication Award recipient, 2008 Despite attempts to interpret and apply lean product development techniques, companies still struggle with design quality problems, long lead times, and high development costs. To be successful, lean product development must go beyond techniques, technologies, conventional concurrent engineering methods, standardized engineering work, and heavyweight project managers. Allen Ward showed the way. In a truly groundbreaking first edition of Lean Product and Process Development, Ward delivered -- with passion and penetrating insights that cannot be found elsewhere -- a comprehensive view of lean principles for developing and sustaining product and process development. In the second edition, Durward Sobek, professor of Mechanical and Industrial Engineering at Montana State University—and one of Ward’s premier students—edits and reorganizes the original text to make it more accessible and actionable. This new edition builds on the first one by: Adding five in-depth and inspiring case studies. Including insightful new examples and illustrations. Updating concepts and tools based on recent developments in product development. Expanding the discussion around the critical concept of set-based concurrent engineering. Adding a more detailed table of contents and an index to make the book more accessible and user-friendly. The True Purpose of Product Development Ward’s core thesis is that the very aim of the product development process is to create profitable operational value streams, and that the key to doing so predictably, efficiently, and effectively is to create useable knowledge. Creating useable knowledge requires learning, so Ward also creates a basic learning model for development. But Ward not only describes the technical tools needed to make lean product and process development actually work. He also delineates the management system, management behaviors, and mental models needed. In this breakthrough text, Ward: Asks fundamental questions about the purpose and “value added” in product development so you gain a crystal clear understanding of essential issues. Shows you how to find the most common forms of “knowledge waste” that plagues product development. Identifies four “cornerstones” of lean product development gleaned from the practices of successful companies like Toyota and its partners, and explains how they differ from conventional practices. Gives you specific, practical recommendations for establishing your own lean development processes. Melds observations of effective teamwork from his military background, engineering fundamentals from his education and personal experience, design methodology from his research, and theories about management and learning from his study of history and experiences with customers. Changes your thinking forever about product development.


Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

Author: Feroz Jameel

Publisher: John Wiley & Sons

Published: 2010-07-13

Total Pages: 986

ISBN-13: 0470595876

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A real-world guide to the production and manufacturing of biopharmaceuticals While much has been written about the science of biopharmaceuticals, there is a need for practical, up-to-date information on key issues at all stages of developing and manufacturing commercially viable biopharmaceutical drug products. This book helps fill the gap in the field, examining all areas of biopharmaceuticals manufacturing, from development and formulation to production and packaging. Written by a group of experts from industry and academia, the book focuses on real-world methods for maintaining product integrity throughout the commercialization process, clearly explaining the fundamentals and essential pathways for all development stages. Coverage includes: Research and early development phase appropriate approaches for ensuring product stability Development of commercially viable formulations for liquid and lyophilized dosage forms Optimal storage, packaging, and shipping methods Case studies relating to therapeutic monoclonal antibodies, recombinant proteins, and plasma fractions Useful analysis of successful and failed products Formulation and Process Development Strategies for Manufacturing Biopharma-ceuticals is an essential resource for scientists and engineers in the pharmaceutical and biotech industries, for government and regulatory agencies, and for anyone with an interest in the latest developments in the field.


Managing New Product and Process Development

Managing New Product and Process Development

Author: Steven C. Wheelwright

Publisher: Simon and Schuster

Published: 2010-07-06

Total Pages: 919

ISBN-13: 1451602316

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Argues that a company's capability to conceive and design quality prototypes and bring a variety of products to market more quickly than its competitors is increasingly the focal point of competition. The authors present principles for developing speed and efficiency.


Pharmaceutical Process Development

Pharmaceutical Process Development

Author: John Blacker

Publisher: Royal Society of Chemistry

Published: 2011-08-17

Total Pages: 375

ISBN-13: 1849733074

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Pharmaceutical process research and development is an exacting, multidisciplinary effort but a somewhat neglected discipline in the chemical curriculum. This book presents an overview of the many facets of process development and how recent advances in synthetic organic chemistry, process technology and chemical engineering have impacted on the manufacture of pharmaceuticals. In 15 concise chapters the book covers such diverse subjects as route selection and economics, the interface with medicinal chemistry, the impact of green chemistry, safety, the crucial role of physical organic measurements in gaining a deeper understanding of chemical behaviour, the role of the analyst, new tools and innovations in reactor design, purification and separation, solid state chemistry and its role in formulation. The book ends with an assessment of future trends and challenges. The book provides a valuable overview of: both early and late stage chemical development, how safe and scaleable synthetic routes are designed, selected and developed, the importance of the chemical engineering, analytical and manufacturing interfaces, the key enabling technologies, including catalysis and biocatalysis, the importance of the green chemical perspective and solid form issues. The book, written and edited by experts in the field, is a contemporary, holistic treatise, with a logical sequence for process development and mini-case histories within the chapters to bring alive different aspects of the process. It is completely pharmaceutical themed, encompassing all essential aspects, from route and reagent selection to manufacture of the active compound. The book is aimed at both graduates and postgraduates interested in a career in the pharmaceutical industry. It informs them about the breadth of the work carried out in chemical research and development departments, and gives them a feel for the challenges involved in the job. The book is also of value to academics who often understand the drug discovery arena, but have far less appreciation of the drug development area, and are thus unable to advise their students about the relative merits of careers in chemical development versus discovery.


Practical Process Research and Development

Practical Process Research and Development

Author: Neal G. Anderson

Publisher: Academic Press

Published: 2012-05-23

Total Pages: 489

ISBN-13: 0123865387

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Designed to provide a comprehensive, step-by-step approach to organic process research and development in the pharmaceutical, fine chemical, and agricultural chemical industries, this book describes the steps taken, following synthesis and evaluation, to bring key compounds to market in a cost-effective manner. It describes hands-on, step-by-step, approaches to solving process development problems, including route, reagent, and solvent selection; optimising catalytic reactions; chiral syntheses; and "green chemistry." Second Edition highlights:• Reflects the current thinking in chemical process R&D for small molecules• Retains similar structure and orientation to the first edition. • Contains approx. 85% new material• Primarily new examples (work-up and prospective considerations for pilot plant and manufacturing scale-up)• Some new/expanded topics (e.g. green chemistry, genotoxins, enzymatic processes)• Replaces the first edition, although the first edition contains useful older examples that readers may refer to - Provides insights into generating rugged, practical, cost-effective processes for the chemical preparation of "small molecules" - Breaks down process optimization into route, reagent and solvent selection, development of reaction conditions, workup, crystallizations and more - Presents guidelines for implementing and troubleshooting processes


Genomic Control Process

Genomic Control Process

Author: Isabelle S. Peter

Publisher: Academic Press

Published: 2015-01-21

Total Pages: 461

ISBN-13: 0124047467

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Genomic Control Process explores the biological phenomena around genomic regulatory systems that control and shape animal development processes, and which determine the nature of evolutionary processes that affect body plan. Unifying and simplifying the descriptions of development and evolution by focusing on the causality in these processes, it provides a comprehensive method of considering genomic control across diverse biological processes. This book is essential for graduate researchers in genomics, systems biology and molecular biology seeking to understand deep biological processes which regulate the structure of animals during development. - Covers a vast area of current biological research to produce a genome oriented regulatory bioscience of animal life - Places gene regulation, embryonic and postembryonic development, and evolution of the body plan in a unified conceptual framework - Provides the conceptual keys to interpret a broad developmental and evolutionary landscape with precise experimental illustrations drawn from contemporary literature - Includes a range of material, from developmental phenomenology to quantitative and logic models, from phylogenetics to the molecular biology of gene regulation, from animal models of all kinds to evidence of every relevant type - Demonstrates the causal power of system-level understanding of genomic control process - Conceptually organizes a constellation of complex and diverse biological phenomena - Investigates fundamental developmental control system logic in diverse circumstances and expresses these in conceptual models - Explores mechanistic evolutionary processes, illuminating the evolutionary consequences of developmental control systems as they are encoded in the genome


Process Development

Process Development

Author: G. Herbert Vogel

Publisher: John Wiley & Sons

Published: 2006-03-06

Total Pages: 492

ISBN-13: 3527604715

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Guiding readers through all steps of the complex process, this book covers the most diverse aspects of chemicals production, including those not or insufficiently covered in natural science courses. These comprise economic feasibility, patenting and licensing, demands on the location and the problem of waste disposal. Throughout, the author does not rely on simple references to other literature but instead reiterates many facts and places them in context, as well as succinctly explaining formulas, thus removing the need to look up items in secondary reference works. As such, the book is suitable for both newcomers as well as those already working in the field. Those working in R&D as well as plant managers will learn how to avoid pitfalls, resulting in higher safety. A common basis and indispensable ready reference for engineers and chemists.


Process Development

Process Development

Author: Jerry Carr-Brion

Publisher: Walter de Gruyter GmbH & Co KG

Published: 2022-02-21

Total Pages: 206

ISBN-13: 3110717913

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Written by an experienced professional, this book introduces chemists to process development, using examples from the pharmaceutical, agrochemical and fragrance industries. The focus is on small molecules rather than biomolecules, and on relatively small-scale production rather than bulk petrochemicals. The coverage is broad, going from initial route development, through pilot plant operations, to full-scale production.


Statistics for Biotechnology Process Development

Statistics for Biotechnology Process Development

Author: Todd Coffey

Publisher: CRC Press

Published: 2018-05-16

Total Pages: 428

ISBN-13: 1351646346

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Written specifically for biotechnology scientists, engineers, and quality professionals, this book describes and demonstrates the proper application of statistical methods throughout Chemistry, Manufacturing, and Controls (CMC). Filled with case studies, examples, and easy-to-follow explanations of how to perform statistics in modern software, it is the first book on CMC statistics written primarily for practitioners. While statisticians will also benefit from this book, it is written particularly for industry professionals who don’t have access to a CMC statistician or who want to be more independent in the design and analysis of their experiments. Provides an introduction to the statistical concepts important in the biotechnology industry Focuses on concepts with theoretical details kept to a minimum Includes lots of real examples and case studies to illustrate the methods Uses JMP software for implementation of the methods Offers a text suitable for scientists in the industry with some quantitative training Written and edited by seasoned veterans of the biotechnology industry, this book will prove useful to a wide variety of biotechnology professionals. The book brings together individual chapters that showcase the use of statistics in the most salient areas of CMC.


Innovating in Product/Process Development

Innovating in Product/Process Development

Author: Mikel Sorli

Publisher: Springer Science & Business Media

Published: 2009-07-01

Total Pages: 289

ISBN-13: 1848825455

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Innovating in Product/Process Development demonstrates how to achieve true innovation in product development, and how to launch a new product in the quickest and cheapest way. The new approach to product development proposed in this book is based on the most recent research in the field. It suggests the integration of several tools that are currently only used independently, with the aim of stimulating the creation of innovative ideas in general, and specifically in the areas of product/process improvements and problem solving. Innovating in Product/Process Development explores different aspects of innovation processes in twenty-first century industry from a global economic perspective. It presents in detail several approaches to support these processes, from ICT-based systems to collaborative working environments, all of which will be of interest to MBA or advanced students; researchers; and design teams charged with the creation of new product lines.