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Investigating late stage biopharmaceutical product loss using novel analytical and process technologyHunnicutt, Leigh Anne January 2008 (has links)
Thesis (M.B.A.)--Massachusetts Institute of Technology, Sloan School of Management; and, (S.M.)--Massachusetts Institute of Technology, Biological Engineering Division; in conjunction with the Leaders for Manufacturing Program at MIT, 2008. / MIT Institute Archives copy: pages, 85-86, 87-88, 89-90 bound in reverse order. / Includes bibliographical references (p. 79-83). / The biopharmaceutical industry uses recombinant protein technologies to provide novel therapeutics to patients around the world. These technologies have presented exciting opportunities for breakthrough medical treatments while creating a host of challenges in the discovery, development and manufacture of these products. Protein aggregation is one of the challenges currently limiting the ability to bring new biopharmaceutical products into the market and to manufacture existing commercial products. The mechanisms of aggregation and subsequent particle formation are highly complex, incompletely understood, and difficult to measure quantitatively with currently available analytical tools. Aggregates, and their effect on product appearance, may compromise value to the patient (bioavailability, dose, therapeutic activity and immunogenicity) as well as value to the company (yield loss and performance in a competitive marketplace) and are therefore tightly regulated. This thesis is intended to explore the problem of protein particles through two main avenues: meeting current regulatory criteria and influencing future regulation. Process changes, analytical characterization, and organizational improvements are each addressed to achieve that goal. An experiment was designed and completed to jointly examine (1) changes to manufacturing processes using novel filtration applications intended to reduce or remove protein particles from solution and (2) analytical tools for improved characterization. Organizational dynamics and resource allocation add an extra layer of complexity and are discussed in relation to leveraging knowledge regarding particles. / (cont.) Additionally, three objectives are established to influence the direction of future regulation: the need for improved characterization, industry collaboration and a healthy interface with regulatory bodies. / by Leigh Anne Hunnicutt. / S.M. / M.B.A.
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The conclusion of a biologic's lifecycle : manufacturing sourcing strategies on the eve of follow-on biologicsPasanek, David M January 2008 (has links)
Thesis (M.B.A.)--Massachusetts Institute of Technology, Sloan School of Management; and, (S.M.)--Massachusetts Institute of Technology, Dept. of Chemical Engineering; in conjunction with the Leaders for Manufacturing Program at MIT, 2008. / Includes bibliographical references (p. [80]-87). / The Amgen Rhode Island facility is dedicated to the production of the biological bulk drug substance (BDS) for Enbrel® (etanercept), which blocks the action of one's immune system, helping to treat immune diseases, such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and psoriasis. A productivity process improvement is currently being implemented that will change the manufacturing capacity of the production process at each of the three separately owned manufacturing facilities for Enbrel® BDS. Given that the Amgen Rhode Island facility currently only produces Enbrel® BDS, the Rhode Island facility has the largest capacity of all the BDS manufacturers, and that Enbrel®'s initial patent expires at the end of 2012; product sourcing is a major concern for both the Rhode Island site and the Enbrel® supply network.As biopharmaceutical companies shift their focus more toward more efficient production operations, issues such as diminishing productivity in drug development and the impact of an emerging follow-on biologics market are becoming critical factors in determining a company's long-term growth and sourcing strategy. This research examines both the qualitative and quantitative components that go into strategic sourcing decisions that are made by innovative biological therapeutic producers. This thesis develops a methodology and framework for strategic sourcing decisions and guidelines for selecting, implementing, and managing relationships within a biotechnological manufacturing network of separately owned facilities as applied to the Enbrel® BDS case study. / by David M. Pasanek. / S.M. / M.B.A.
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Evaluating end-of-life strategies for decommissioned semiconductor facilitiesStewart, Kevin Michael January 1997 (has links)
Thesis (M.B.A.)--Massachusetts Institute of Technology, Sloan School of Management; and, (S.M.)--Massachusetts Institute of Technology, Dept. of Civil and Environmental Engineering; in conjunction with the Leaders for Manufacturing Program at MIT, 1997. / Includes bibliographical references (p. 117-118). / This thesis studies the life-cycle of semiconductor facilities and the potential roles that they may play once they reach the end of their life. Specifically, the author's findings are based on studies associated with the decommissioning of a semiconductor manufacturing facility ("fab") at the Intel Corporation's Aloha Campus in Portland, Oregon. With increasing demarids for its products, Intel is constructing newer and more modern facilities to support large-scale manufacturing efforts. As newer product lines and facilities come on line, older product lines are being eliminated and older semiconductor facilities that produced them are consequently being shut down largely without regard for what their use will be afterwards. As such, this study starts by first looking at the concept of facility life-cycle with respect to semiconductor manufacturing facilities. After discussing potential pre-shutdown planning requirements, the author presents an empirical framework for evaluating possible roles that these fabrication facilities could play after they are taken out of service. In brief, the framework consists of five general steps - (1) establish reference state; (2) develop list of alternatives; (3) establish decision factors; (4) generate measures for comparison; and (5) compare and contrast to draw conclusions -and is based upon a thorough consideration of all relevant technical, strategic, and financial issues. The paper then applies the framework to a current semiconductor manufacturing facility that was the focus of this research. The example developed for Intel's Fab 4 demonstrates that a combination of a short-term role (utilizing the building as a manufacturing support platform) and a long-term strategy (combining the resources of Fab 4 and Fab 5) appears to be the "most feasible" set of alternatives. In addition, the methodology is then applied to other examples of past and potential future wafer fabrication facility decommissioning projects. Conclusions from this research indicate that a process-oriented (rather than outcome-oriented) framework best captures the iterative and dynamic nature of the problem. As such, the major contribution of this methodology is that it presents a framework for how to think about the problem rather than how to immediately solve it. As such, the author believes that the research results presented herein are not intended to be a panacea for what remains to be a difficult problem. However, since companies will no longer be able to walk away from existing facilities, the author concludes that incremental investment and planning for adaptive re-use during the facility's lifetime would appear to offer numerous advantages over waiting until after it is shut down. / by Kevin Michael Stewart. / S.M. / M.B.A.
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Designing a supply chain for a foreign Greenfield facilityAnstey, Brian (Brian Mark), II January 2009 (has links)
Thesis (M.B.A.)--Massachusetts Institute of Technology, Sloan School of Management; and, (S.M.)--Massachusetts Institute of Technology, Engineering Systems Division; in conjunction with the Leaders for Manufacturing Program at MIT, 2009. / Vita. / Includes bibliographical references (leaf 64). / ABB Schweiz AG has experienced substantial growth in demand for the innovative energy management and conversion products designed and assembled by the Medium Voltage Automation Products Division. This demand has fully consumed the capacity in their assembly facilities worldwide and has driven the organization to initiate planning of a ten thousand square meter assembly facility in Lodz, Poland. This thesis focuses on the design and implementation of the supply chain for the new facility. By utilizing supply chain optimization concepts, the network of hundreds of suppliers, two warehouses, and multiple assembly and test locations has been optimized. This thesis details the application of theoretical models, such as the economic order quantity model, continuous review inventory policies and generalized power rule forecasting, in the development of inventory management guidelines for the Greenfield facility's supply chain. Additionally, the document details the practical challenges associated with implementation including customs clearance, business plan development, supplier involvement and packaging strategy. / by Brian Anstey, II. / S.M. / M.B.A.
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Developing a methodology to link printed circuit board assembly yield targets to commodity group quality goalsCauthen, Jason Wessing January 2009 (has links)
Thesis (M.B.A.)--Massachusetts Institute of Technology, Sloan School of Management; and, (S.M.)--Massachusetts Institute of Technology, Engineering Systems Division; in conjunction with the Leaders for Manufacturing Program at MIT, 2009. / Includes bibliographical references (p. 62-63). / The increasing complexity of high-end routing products, a highly diverse product mix, and continually demanding quality requirements have intensified the challenges faced by Cisco. Primary among these is managing the broad array of suppliers to ensure that the parts they are delivering meet the quality needs of the end product while balancing this with the need to remain cost competitive. Because components are often used across many product lines, it is can be difficult to determine exactly how an improvement to the quality of an individual component will impact Cisco's overall yield metrics. This thesis establishes a methodology for linking component quality to assembly-level yields. The component level quality is measured in Defective Parts Per Million (DPPM) at the Commodity Group level, and PCBA Yield is measured as the percentage of boards which meet Cisco's Six Sigma yield targets. The proof of concept for such an analytical link shows that these two metrics can be analytically related, and furthermore can be used to ensure that the effort expended to improve DPPM is optimally targeted to have an impact on assembly-level yields. / by Jason Wessing Cauthen. / S.M. / M.B.A.
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Inter-company collaboration within a large lean supply chain initiativeMentzer, Maria Ritums January 2009 (has links)
Thesis (M.B.A.)--Massachusetts Institute of Technology, Sloan School of Management; and, (S.M.)--Massachusetts Institute of Technology, Dept. of Civil and Environmental Engineering; in conjunction with the Leaders for Manufacturing Program at MIT, 2009. / Includes bibliographical references (p. 94-95). / Cisco and its four contract manufacturing partners are collaborating to implement a lean replenishment methodology across their supply chain. The new system is expected to result in minimized inventory exposure, increased supply chain flexibility, and improved speed to customer. Implementation of such a large standardized initiative requires close collaboration within and between multiple companies which makes it even more complex. Understanding the current state of collaboration within such a large initiative will enable improvements for future inter-company initiatives. This work analyses how Cisco and Flextronics collaborate within this large joint initiative. The analysis utilizes a combination of process mapping and known frameworks for organizational and cross company collaboration analysis. In addition, a dynamic supply chain simulation addressing a particular concern within the initiative is provided. Based on this characterization recommendations for how Cisco and Flextronics can improve collaboration for future joint initiatives are made. / by Maria Ritums Mentzer. / S.M. / M.B.A.
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Stock level optimization at the distribution center through improved supply management practicesVega González, Myraida Angélica January 2009 (has links)
Thesis (M.B.A.)--Massachusetts Institute of Technology, Sloan School of Management; and, (S.M.)--Massachusetts Institute of Technology, Dept. of Mechanical Engineering; in conjunction with the Leaders for Manufacturing Program at MIT, 2009. / Includes bibliographical references (p. 84-85). / This thesis focuses on an inventory and supply management improvement project at Inditex, SA Corporation. Inditex has experienced a higher percentage increase in inventory than in sales over the past few years. As a fast-fashion power house and the largest fashion distributor in the world since August 2008, this trend goes directly against its corporate strategy and competitive advantage. The internship project addresses this trend by focusing on the deterioration in the company's supply management practices. The project developed an optimization model which minimizes total supply chain cost in order to define order points and quantities for a given reference whose demand and variability were also modeled. As a result of these efforts, theoretical inventory turns may be decreased, on average, by 19%. While these preliminary results are promising, organizational barriers to adoption must also be carefully addressed throughout the project's implementation period. To minimize these risks, a phased implementation approach is recommended which addresses both the technical and organizational hurdles and must be overcome before successful adoption of the tool across the company. / by Myraida A. Vega González. / S.M. / M.B.A.
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Implementing various lean methodologies and creating a business development plan at an ABB Greenfield siteSosa Rangel, Miguel Ernesto January 2009 (has links)
Thesis (M.B.A.)--Massachusetts Institute of Technology, Sloan School of Management; and, (S.M.)--Massachusetts Institute of Technology, Dept. of Mechanical Engineering; in conjunction with the Leaders for Manufacturing Program at MIT, 2009. / Includes bibliographical references (p. XX). / As part of its strategic initiatives, ABB inaugurated a 100,000 sq-m campus for an Engineering, Sourcing, and Manufacturing Operations center in San Luis Potosi (SLP), Mexico in May 2008. The ramp-up of the SLP site encompassed two focus areas that are the topics for this thesis. The first area of focus was to create a business development guide that supports Mexican and North American division managers, plant managers, and their supporting personnel to successfully establish new business in SLP. Having such a guide available is expected to reduce start-up time of operations, increase decision-making speed, improve productivity in multi-divisional projects, and ultimately increase potential internal business opportunities. This thesis presents a case study on how this guide was designed, developed, and implemented. The second focus area was to implement several Lean principles, the most significant one being "5S." A case study on its planned application, procedure to measure implementation level and effectiveness on quality, productivity, and on-time delivery is discussed. A discussion on the stronger emphasis by management on implementation measurement versus effectiveness measurement and possible reasons for this gap of expectations is also presented. Finally, the production area for the Robot Refurbishment line was redesigned based on the target of reducing factory floor space for use in other ventures, meanwhile simultaneously increasing lead times in the manufacturing process. / by Miguel Ernesto Sosa Rangel. / S.M. / M.B.A.
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Component acquisition and single-source vendor management strategy in a defense applicationHammer, Lory (Lory Yeamans) January 2009 (has links)
Thesis (M.B.A.)--Massachusetts Institute of Technology, Sloan School of Management; and, (S.M.)--Massachusetts Institute of Technology, Dept. of Mechanical Engineering; in conjunction with the Leaders for Manufacturing Program at MIT, 2009. / Includes bibliographical references (p. 51-52). / Building an aircraft carrier is one of the most complex manufacturing undertakings in the world. Each component must be designed, tested and manufactured to not only Northrop Grumman Shipbuilding's (NGSB) exceptionally high standards, but also to the standards, requirements and approvals of both the Navy and the US Federal Government. As a result of these standards and requirements, lead times for construction materials can exceed two years, while a similar component, purchased for industrial use may have a lead time of 90 days. To add to the complexity, the scheduled delivery date for the carrier is fixed, and compressed so that engineering design and construction must take place concurrently. In essence, the ship is under construction years before the design is complete. As a result of concurrent engineering, a complex procurement process and a limited vendor base, some material is chronically late to the Required-in-Yard (RIY) date, causing deviations from the optimal construction schedule and impacting the cost of the ship. This thesis analyzes the current CVN 78 valve purchasing process to identify opportunities to leverage the product model and existing process infrastructure to improve material delivery to schedule and decrease construction costs for CVN 79. It is the goal of this research to improve the supply chain to support the preferred construction schedule, while reducing cost and risk associated with component acquisition. This thesis begins with an analysis of the current supply chain system within NGSB New Carrier Construction. / (cont.) It then explores the current state of vendor relations between NGSB and the supply base. The cost impact for delaying construction due to delinquent valves is identified and presented. Then specific vendor management strategies are examined. This thesis proposes a framework for improving on-time delivery of the component and lowering overall supply chain cost by (1) pursuing strategic alliances with valve vendors, (2) providing greater visibility of demand earlier in the engineering design cycle and (3) using this visibility to drive procurement timing to improve delivery to scheduled need date. The thesis presents a case study in vendor collaboration and provides recommendations. Finally, it discusses the impact of applying the framework to similar components within the New Carrier Construction Program and the potential application of the framework to NGSB's other active programs and shipbuilding locations. / by Lory Hammer. / S.M. / M.B.A.
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Information management using Web 2.0 technologyDuffy, Juliet (Juliet Maria) January 2009 (has links)
Thesis (M.B.A.)--Massachusetts Institute of Technology, Sloan School of Management; and, (S.M.)--Massachusetts Institute of Technology, Dept. of Chemical Engineering; in conjunction with the Leaders for Manufacturing Program at MIT, 2009. / Includes bibliographical references. / Web 2.0, the ultimate platform for tacit based knowledge work has finally arrived. User driven, collaborative platform based tools including wikis, web mash-ups, discussion boards, linkage based search engines, and tagging have the potential to vastly change how information is managed and how knowledge work is captured. This thesis investigates how the new paradigms and tools of Web 2.0 can be applied to the Pharmaceutical Industry and assist with information management at The Novartis Institute for BioMedical Research (NIBR). Applying Web 2.0 tools to NIBR's chemical compounds, targets, assays, people, and projects in a well thought out framework has the potential to yield tremendous productivity improvements in the drug discovery process. Effectively harnessing the collective intelligence of thousands of scientists within Novartis's worldwide research network will enable a paradigm shift. A large, extremely knowledgeable user community can more effectively annotate metadata, hyperlink to important content, establish tags, and collectively author content. Such activities will not only improve the search ability of information but also allow important scientific connections to emerge linking biology to chemistry and furthering Novartis's understanding of disease. / by Juliet Duffy. / S.M. / M.B.A.
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