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 121 for “"biologics"”.
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Stealth Polymer Conjugates of Biologics
<p>Biologics are potent, highly specific, and well-tolerated and have become an important class of drugs. Despite their promise, most of them have a short half-life due to rapid renal elimination and in vivo degradation. Their short in vivo half-life hence necessitates frequent injections, …
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Dose reduction of biologics in psoriasis
Contains fulltext : 240236.pdf (Publisher’s version ) (Open Access)
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Modeling variability for biologics strategic planning
Making strategic decisions about resource capabilities in the uncertain business of drug development is a challenging task. Novartis, a Swiss pharmaceutical company, is expanding from its success in small molecule therapeutics into the attractive area of biologic therapeutics, both monoclonal …
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Mining Marine Environments for Novel Antimicrobial Biologics
Deaths attributable to antimicrobial resistance (AMR) are predicted to rise from 700,000 per year now to 10 million by 2050. There is an urgent need for new antibiotics to meet the threat posed by AMR; the WHO recently reported that there are not enough antibiotics in development to meet this need. …
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Review of drug and biologics recalls: 2009 through 2019
<p>This study analyzed drugs and biologics recalls for the period of 2009 and 2019. The data used in the study was generated from Food and Drug Administration records. A total of 466 drugs and 84 biologics were recalled during the 11-year period. The common causes of drug product recalls included …
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Capacity planning under demand and manufacturing uncertainty for biologics
Due to the long lead times and complexity in drug development and approval processes, pharmaceutical companies use long range planning to plan their production for the next 10 years. Capacity planning is largely driven by the long-term demand and its forecast uncertainty. The impact of …
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Ex-Vivo Injection of Biomaterial Biologics for Treatment of Osteonecrosis
BACKGROUND: A loss of blood flow to bone produces osteonecrosis, characterized by cell necrosis and tissue destruction. This necrotic microenvironment induces chronic inflammation, poor bone regeneration, joint deformity, osteoarthritis, and potentially a total joint replacement. One potential …
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Enhancing Workflows in Biologics Drug Substance Process Development Through Automation
… the thesis is focused on its application to biologics process development within Amgen. It is used to assess the value of implementing a specific high throughput platform, Sartorius ambr® 250 systems, in upstream biologics process development. Through mapping and analyzing the workflows of …
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Experimental methodology for non-thermal effects of electromagnetic radiation on biologics
… RFID radiation produces significant effects in biologics. Furthermore, we document a method for determining specific absorption rate (S.A.R.) using vials containing 1.5 cc of saline to represent biological samples. This methodology yielded S.A.R. values of approximately 30 W kg-1(-9 dBm) and 150 …
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Tailored Base Surge Policy for Middle Echelon in Biologics Supply Chain
The Biologics division of AstraZeneca is a growing part of the business, by introducing new and existing products to more markets and therapy areas. Given uncertainty in both supply and demand, the current strategy includes holding inventory at strategic locations throughout the supply chain to …
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Brokering strategic partnerships between Asian and western biopharmaceutical companies in the global biologics market : assessment of capabilities of Asian participants in the biologics contract manufacturing organization marketplace
… emphasis on biotechnology medicines (or biologics). Recent large business deals that have seen Pfizer acquire Wyeth, Merck acquire Schering-Plough and Roche complete the acquisition of Genentech all have some element of positioning around the exploitation of biologics for future growth. …
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Approvals, Utilization, and Cost of Biologics for the Treatment of Rheumatoid Arthritis
<p><strong>Introduction:</strong> RA treatment has been revolutionized by the development and approval of biologic disease-modifying antirheumatic drugs (bDMARDs). However, the approval status, utilization, and high cost of bDMARDs pose challenges in RA management.</p> …
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Microfluidic-engineered N-acetylcysteine crystals for oxidative stress control and biologics manufacturing
Submission original under an indefinite embargo labeled 'Open Access'. The submission was exported from vireo on 2023-09-01 without embargo terms
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Long range planning of biologics process development and clinical trial material supply process
… market share. For these reasons, Novartis Biologics wanted to develop a simulation model to provide an objective opinion and assist them in their long-range planning. This thesis describes the design, development, and functionalities of the resultant model. During validation runs, the model …
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Evaluating the impact of critical product quality attributes on patient outcomes in biologics
The primary goal of this project is to link critical product quality attributes in biological medicines with patient outcomes as evidenced by clinical trial data. This project adopts a novel methodology of applying statistical and machine learning models on a dataset combining data on clinical …
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Evaluation of the financial impact of continuous chromatography in the production of biologics
… one. This is particularly relevant, as biologics represent the fastest growing segment of the human therapeutics market, and, consequently, have become a major component of most large pharmaceutical companies, such as Novartis.' Specifically, I examined the Multicolumn Countercurrent …
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Improving predictability of cell culture processes during biologics manufacturing scale-up through hybrid modeling
In the biotechnology industry, commercial manufacturing of biologic drugs occurs in large-scale production bioreactors (15,000L), but process development occurs in lab-scale production bioreactors (2-3L). Cell culture processes are complicated and the scale-up from bench-scale to commercial-scale …
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Design of load-lock door for unit dose continuous lyophilization process for complex biologics
The process of unit dose continuous lyophilization consists of moving vials containing unit doses of pharmaceutical product though a series of process chambers with varying pressures and temperatures. In order to move the vials between process chambers with varying pressures without disturbing the …
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Product management framework for the development of automation solutions for biologics drug substance manufacturing
This thesis presents a product management framework for the development of innovative manufacturing automation solutions, and the application of this framework to the development of automation for a continuous biomanufacturing platform at Amgen. A recently formed team at Amgen - Next Gen Automation …
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