Global ETD Search
Search theses and dissertations gathered from participating repositories worldwide. Every result links back to the library that holds it. No account is needed.
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Showing 1 to 20 of 50 for “"biomanufacturing"”.
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Biomanufacturing Automation Plug & Play
In the biopharmaceutical industry today, the software of manufacturing equipment requires custom coding and lengthy efforts to integrate any new piece of equipment with others in a process. Plug-and-play is an evolving concept that would enable new equipment to quickly connect and seamlessly …
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Revolutionizing standard operating procedures in biomanufacturing
In its quest to become a High Reliability Performance (HRP) organization, Amgen manufacturing operations desires to further improve its adherence to, and effectiveness of, its standard operating procedures (SOPs). SOPs are expected to provide clear guidance to operators to enable them to perform …
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Advancing lean implementation for next generation biomanufacturing operations
… (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 …
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An Investigation of Multivariate Process Control for Biomanufacturing
… not fundamentally changed in decades. Outside of biomanufacturing, process control technologies have advanced to include multivariate and predictive control. This project examines the feasibility of developing a generalized multivariate control scheme proof of concept to link several individual …
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Reducing complexity In biomanufacturing operations through single-use assemblies
Novartis Vaccines and Diagnostics operates a centralized equipment cleaning and preparation suite at a vaccine production facility in Marburg, Germany. The ~100 pieces of multi-use stainless steel, glass, and plastic equipment prepared at this centralized pretreatment suite all need to be …
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Sensor-based Characterization and Control of Additive Biomanufacturing Processes
… and the fabrication of organs using additive biomanufacturing (Bio-AM) processes. While progress toward industrial-scale production of 3D-bioprinted tissue models and organs remains hindered by various biological and tissue engineering challenges, such as vascularization and innervation, …
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Optimizing Integrated Continuous Biomanufacturing Throughput: Resource Constraints and Process Scheduling
… is to understand the available capacity of a biomanufacturing facility with respect to a product of interest. Further, the thesis aims to find opportunity to increase the system’s throughput and to determine whether current labor resources are sufficient to enable production at this level. To …
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Text Analytics to Inform Deviation Root Cause Analysis in Biomanufacturing
In biomanufacturing, product quality and safety are critical and there are many controls in place to ensure that processes are followed within the prescribed operating limits. However, deviations from these processes inevitably occur, sometimes requiring in-depth investigations to determine the …
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IoT at Amgen - Evaluating and Piloting Industry 4.0 Technology in Biomanufacturing
… to provide new capabilities within existing biomanufacturing practices. However, selecting and prioritizing potential IoT investments- especially given the mature wired instrumentation infrastructure of Amgen’s manufacturing facilities- remains a challenge. This thesis examines the adoption …
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Investigating Non-model Microorganisms for Biomanufacturing via Systems Biology and Machine Learning
Non-model microorganisms are becoming promising biomanufacturing chassis well-suited for production of sustainable oleochemicals. The expansion of synthetic biology tools has allowed for efficient redirection of carbon towards products, generating numerous production strains at the laboratory …
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Continuous Antibody Titer Assessment of the Biomanufacturing Process using Nanofluidic Binding Assays
… enables the implementation of quality-by-design biomanufacturing, rapid bioprocess decision-making, and process optimization. Intermittent sampling and analysis are presently utilized to maintain long-term perfusion culture. However, this increases the risk of introducing external contaminants …
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Industry 4.0 in Biomanufacturing: Predictive Real-Time Models Using Process Analytical Technology
In biomanufacturing, process analytical technology (PAT) has become an essential tool for improving product quality, reducing costs, and increasing efficiency. In this thesis, we collect capacitance and optical density data from two in-line sensors in production bioreactors to compute real-time …
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A systematic approach for assessing next generation technologies and solutions in biomanufacturing
… 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 …
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Enhancing the design and procurement of single-use assemblies in biomanufacturing by implementing modular specifications
Usage of single-use systems (SUS) in biomanufacturing has expanded rapidly in recent years. Amgen uses SUS at several commercial manufacturing sites, in addition to pilot plants and clinical production. Each single-use assembly is typically custom designed and manufactured by a third-party …
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Closing gaps in global access to biologic medicines : building tools to evaluate innovations in biomanufacturing
Low-and-Middle Income Countries (LMICs) are experiencing a growing need for safe, effective, and affordable health services, especially medicines. Such trends are in part due to a continued epidemiologic transition from infectious to chronic, non-communicable diseases (NCDs). Today, NCDs account …
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Institutions, public policy and the product life cycle : the globalization of biomanufacturing and implications for Massachusetts
Globalization has brought about a major shift in our understanding of how companies organize themselves and how they compete. The fragmentation of firms in their scope and structure, the vertical disintegration of firms through greater outsourcing, and the rise of global supply and value chains has …
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Biomanufacturing of Bacteria-Mediated Drug Delivery Systems and Investigation of Their Interaction with the Tumor Microenvironment
The limited transport of conventional chemotherapy within the tumor microenvironment (TME) is due to irregular vascularization, increased tumor interstitial pressure, and a dense extracellular matrix (ECM). The lack of selectivity of anticancer drugs often leads to systemic toxicity and damage to …
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Globalization of biopharmaceutical manufacturing
The biomanufacturing industry is changing due to increasing globalization. However, it is changing differently from other high tech industries like software/ semiconductor/ automobiles. In this study we use global biomanufacturing investment data, industry survey data as well as interviews with …
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Novel micro/nanofluidic system for separation and monitoring of cells and proteins in perfusion
… for many health conditions. Continuous biomanufacturing is one of the top technology trends in the biopharmaceutical industry to improve biological product quality and reduce manufacturing cost. This thesis introduces novel high-throughput microfluidic cell separation and nanofluidic …
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