On July 30-31, 2018, the National Academies of Sciences, Engineering, and Medicine held a workshop titled Continuous Manufacturing for the Modernization of Pharmaceutical Production. This workshop discussed the business and regulatory concerns associated with adopting continuous manufacturing techniques to produce biologics such as enzymes, monoclonal antibodies, and vaccines. The participants also discussed specific challenges for integration across the manufacturing system, including upstream and downstream processes, analytical techniques, and drug product development. The workshop addressed these challenges broadly across the biologics domain but focused particularly on drug categories of greatest FDA and industrial interest such as monoclonal antibodies and vaccines. This publication summarizes the presentations and discussions from the workshop.

Modern Manufacturing Processes draws on the latest international research on traditional and non-traditional practices, to provide valuable advice on the digitization and automation of the manufacturing industry. In addition to providing technical details for the correct implementation of the latest tools and practices, the impacts on productivity and design quality are also examined. The thorough classification of manufacturing processes will help readers to decide which technology is most effective for their requirements, and comparisons between modern and traditional methods will clarify the case for upgrading. This comprehensive assessment of technologies will include additive manufacturing, and industry 4.0, as well as hybrid methods where exceptional results have been gained through the use of traditional technology. This collection of work by academics at the cutting edge of manufacturing research will help readers from a range of backgrounds to understand and apply these new technologies. - Explains how the correct implementation of modern manufacturing processes can help a factory gain the characteristics of an industry 4.0 business - Explores what the main technical and business drivers for new manufacturing processes are today - Provides detailed classifications and comparisons of traditional, non-traditional, and hybrid manufacturing processes

Recent years have seen a lively debate over the role of tacit knowledge and interactive learning in privileging the local over the global. Yet, our continuing inability to answer questions such as 'when and why is the local important in production and innovation processes?' indicates that our understanding of the firm and the forces that shape its managers' choices remains weak. Such a theory ought to be able to answer fundamental questions like: why do firms in particular places adopt particular production and innovation practices, and not others? What forces determine what a firm 'knows' and when it is able to act upon this knowledge? How easy is it to transfer this knowledge between places? This book presents a new conception of industrial practice and firm behaviour. It explains how the cultures that shape the practices of firms and the trajectories of regional and national economies are actually produced. The analysis shows how the internal and inter-firm organization of production, use of technologies, and the industrial knowledge underpinning these practices are strongly influenced by their social and institutional context. Routine forms of behaviour are not simply inherited from past practice. Instead, they are shaped and constrained - though not wholly determined - by a set of institutions that govern how work is organized, workers are deployed, and technology is implemented. Because of the slowly evolving nature of these institutions, distinctive national 'models' are not converging around a single global norm.

The book fills an important gap in understanding the process of economic transformation by providing a comprehensive and in-depth micro-level analysis of industrial transition. . . The book is highly recommended for those who are working on or studying the Chinese economic transformation focusing especially on industry and its transition. Ligang Song, Economic Record As the authors admit, the wool industry may seem a rather obscure choice (p. 23). Yet this is a book of interest to a much wider relationship than agro-business specialists. It provides a meticulous case-study of one industry which illuminates a number of broader issues currently under discussion in the China studies field. . . As the Chinese economy becomes more variegated, economists and political scientists trying to understand the Chinese economic reform experience will increasingly have to rely on such studies. They bring out the intricacies of this process and help us to move from across-the-board generalizations on property rights reform to more nuanced analyses of economic transition. Björn Alpermann, The China Journal China defies generalizations, and the only way that we can hope to obtain a clear idea of the process of reform is through detailed studies, that trace the complex ebb and flow of reforms, including the interactions between centre and locality, and between the stages of the processing. This is a valuable study that will stand the test of time. Will Martin, The World Bank, US This book is more than yet another industry report . This is a book on transition. It describes the mega-forces privatization; state-owned enterprise reform; internationalization; increasing competition and their mega-consequences the proliferation of small, private traders; the diversification of the process sector; the disintegration of government agencies and private initiatives that had been in charge of coordinating and managing quality that not only affected the wool sector, but are literally re-defining the fabric of China s economy. For those interested in trying to better understand the fastest growing economy in the world, this is a must read. Neither the authors competence in wool technology nor their description of the institutional details of the wool economy gets in the way of their main message. Powerful economic forces are at work in China. In some cases there are positive benefits through competitive and improved incentives. In other cases, however, there is a cost in terms of rising transaction costs, imperfect information and the inability to rationalize the evolving supply chains. Scott Rozelle, University of California, US China is the world s largest producer and consumer of wool textiles but the structure of its industry remains confusing and complex to many. While China offers the most important growth opportunity in the world today, the transition from a centrally planned to a market economy has compounded the difficulties and risks for many traders and investors wishing to deal with and in this market. This publication makes a major contribution towards unravelling the complexity of Chinese industrial structures through its review of recent changes to one of China s oldest but still significant manufacturing sectors, the wool textile industry. The lessons learned through this study will be relevant to anyone wishing to understand China s industrial modernization processes. Barry White, Chief Executive Officer, International Fibre Council (IFC) Ltd, Director, Australia China Business Council Exposed to powerful new economic forces, and undergoing dramatic ownership reforms and technological changes, China s industries are modernizing at a breakneck pace. In many industries, the outcomes have been chaotic and poorly aligned with societal objectives. This book analyses the transformation and modernization of China s industries through a detailed investigation of the wool and wool textile industries. The authors argue that to remai

Stuart A. Rosenfeld presents a timely analysis of the problems the United States and other industrialized countries face as they adjust from economies based on natural resources and goods to economies based on quality of human resources and high-performance, market-oriented organizations. Some of the questions raised include: Will American industry successfully face the competitive challenge of the global economy? Can US manufacturing raise productivity and innovate enough to remain healthy? Have the latest advances in process technology and management practice penetrated the rural industrial base? How can public policy help improve the competitiveness of the crucial manufacturing sector? This book challenges the conventional wisdom in economic development policy. Past state and local industrial policy focused on locational decisions, not on issues of competitiveness. Building the competitive advantage of industry is more important than promoting the competitive advantages of location. Incentives to modernize are more important than subsidies to locate. Competitive Manufacturing uses the rural South, the most industrialized rural region of the nation, to examine the strengths and weaknesses of manufacturing as the basis for economic growth. Using historical analysis, surveys, and intensive case studies, the author analyzes the technological capabilities of rural manufacturing, the factors that influence the decision to modernize, and the effects of technology on education and work. Comparative studies in Denmark and Italy point to new directions for US economic development policy.