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Dissertations / Theses on the topic 'Biologics'

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1

Conant, Tamara L. (Tamara Lynn). "Modeling variability for biologics strategic planning." Thesis, Massachusetts Institute of Technology, 2009. http://hdl.handle.net/1721.1/53311.

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Thesis (S.M.)--Massachusetts Institute of Technology, Dept. of Electrical Engineering and Computer Science; and, (M.B.A.)--Massachusetts Institute of Technology, Sloan School of Management; in conjunction with the Leaders for Manufacturing Program at MIT, 2009.<br>Cataloged from PDF version of thesis.<br>Includes bibliographical references (p. 46).<br>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
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2

Pasanek, David M. "The conclusion of a biologic's lifecycle : manufacturing sourcing strategies on the eve of follow-on biologics." Thesis, Massachusetts Institute of Technology, 2008. http://hdl.handle.net/1721.1/44321.

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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.<br>Includes bibliographical references (p. [80]-87).<br>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.
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3

Shama, Leslie Marie. "Risk Assessment of Plant-Based Pharmaceuticals and Biologics." Thesis, Montana State University, 2006. http://etd.lib.montana.edu/etd/2006/shama/ShamaL1206.pdf.

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Biotechnology is evolving to produce pharmaceutical proteins in plants. Plantbased pharmaceutical production creates concerns of exposure in an open environment and contamination of the food supply. Consequently, quantitative human health and ecological risk assessments were conducted for aprotinin, gastric lipase, and LT-B expressed in maize. A comparative, qualitative risk assessment was conducted for conventionally derived and plant-cell derived Newcastle disease virus vaccine. Effect and exposure scenarios were modeled for each quantitative risk assessment and each scenario was based on a
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4

Luo, Sifo. "Capacity planning under demand and manufacturing uncertainty for biologics." Thesis, Massachusetts Institute of Technology, 2017. http://hdl.handle.net/1721.1/112865.

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Thesis: M. Eng. in Supply Chain Management, Massachusetts Institute of Technology, Supply Chain Management Program, 2017.<br>Cataloged from PDF version of thesis.<br>Includes bibliographical references (page 58).<br>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 uncertainties at manufacturing level, such as factory productivity and production success rate, a
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5

Jain, Saurabh Ashok. "The development of biologics for use in translational medicine." Thesis, University of Edinburgh, 2015. http://hdl.handle.net/1842/21117.

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In this research, we developed a wide range of biological tools against two distinct targets from future diagnostic or therapeutic points of view. Firstly, we demonstrate that sporadic canine B cell lymphoma mimics the features of human equivalents which in turn will be advantageous for development of canine as well as human therapeutics. With a comparative oncological approach, here we developed a monoclonal antibody (NCD1.2) against canine CD20 which also binds to its human counterpart. Using flow cytometry and tissue microarray, we show that NCD1.2 binds specifically to canine B cell lympho
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6

Cox, Felicia C. A. I. "Experimental methodology for non-thermal effects of electromagnetic radiation on biologics." Thesis, Massachusetts Institute of Technology, 2006. http://hdl.handle.net/1721.1/36778.

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Thesis (M. Eng.)--Massachusetts Institute of Technology, Dept. of Electrical Engineering and Computer Science, 2006.<br>Includes bibliographical references (p. 133-137).<br>Appropriate equipment is needed for research on the effects of radio-frequency radiation from radio-frequency identification (RF-ID) systems on biological materials. In the present study, a complete test system comprising assembled hardware and custom-built software was developed for a research project investigating whether RFID radiation produces significant effects in biologics. Furthermore, we document a method for deter
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7

Chun, Soo Jin S. M. Massachusetts Institute of Technology. "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." Thesis, Massachusetts Institute of Technology, 2009. http://hdl.handle.net/1721.1/63014.

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Thesis (S.M.)--Harvard-MIT Division of Health Sciences and Technology, 2009.<br>Cataloged from PDF version of thesis.<br>Includes bibliographical references (p. 51-58).<br>It has become increasingly important for companies in the biopharmaceutical industry to maximize the clinical, commercial and economic impact of their products on a global scale. In this context, both Western and Asian firms have been engaging in international merger and acquisition (M&A) activities to improve global capabilities and competiveness. The M&A activities in the sector are driven by near-term expiration of blockb
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8

Rorrer, Rebecca Kathleen. "Veterinary Therapeutic and Biologic Agents in Virginia Sheep Production." Thesis, Virginia Tech, 2002. http://hdl.handle.net/10919/34574.

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Biological and therapeutic agents are used in food animal production to maintain animal health and well being, prevent and treat disease, and to maintain or enhance production. Concerns about the use of pharmaceutical agents in food animal production have been raised, especially in relation to food quality and safety. This study addressed the scarcity of information concerning the quantity of pharmaceuticals being used and the reasons for their use in sheep production. Additional goals included determining the sources of information used by shepherds in making treatment decisions and evalua
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9

Atzinger, Christopher B. "Impact of Ultrasonography on use of Biologics in Patients with Rheumatoid Arthritis." University of Cincinnati / OhioLINK, 2018. http://rave.ohiolink.edu/etdc/view?acc_num=ucin1522165400676313.

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10

Volk, Anna-Luisa. "Cell line and protein engineering tools for production and characterization of biologics." Doctoral thesis, KTH, Proteomik och nanobioteknologi, 2017. http://urn.kb.se/resolve?urn=urn:nbn:se:kth:diva-212931.

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Our increasing understanding of disease mechanisms coupled with technological advances has facilitated the generation of pharmaceutical proteins, which are able to address yet unmet medical needs. Diseases that were fatal in the past can now be treated with novel biological medications improving and prolonging life for many patients. Pharmaceutical protein production is, however, a complex undertaking, which is by no means problem-free. The demand for more complex proteins and the realization of the importance of post-translational modifications have led to an increasing use of mammalian cells
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11

Takizawa, Bayan Teisho. "Evaluation of the financial impact of continuous chromatography in the production of biologics." Thesis, Massachusetts Institute of Technology, 2011. http://hdl.handle.net/1721.1/66045.

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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 Global Operations Program at MIT, 2011.<br>Cataloged from PDF version of thesis.<br>Includes bibliographical references (p. 69-70).<br>The primary goal of this internship is to explore the financial impact of changing one or more of the downstream chromatography steps involved in the purification of a complex biologic molecule from a batch process to a continuous one. This is particularly releva
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12

Edwards, Emily (Emily Rose). "Long range planning of biologics process development and clinical trial material supply process." Thesis, Massachusetts Institute of Technology, 2011. http://hdl.handle.net/1721.1/66068.

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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 Global Operations Program at MIT, 2011.<br>Cataloged from PDF version of thesis.<br>Includes bibliographical references (p. 50).<br>This thesis investigates the feasibility of using a complex model with a Monte Carlo simulation model to forecast the financial, personnel, and manufacturing capacity resources needed for biologic drug development. Accurate forecasting is integral across industries
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13

Singh, Shalini Shreekant. "Evaluating the impact of critical product quality attributes on patient outcomes in biologics." Thesis, Massachusetts Institute of Technology, 2019. https://hdl.handle.net/1721.1/122583.

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Thesis: M.B.A., Massachusetts Institute of Technology, Sloan School of Management, 2019, In conjunction with the Leaders for Global Operations Program at MIT<br>Thesis: S.M., Massachusetts Institute of Technology, Department of Civil and Environmental Engineering, 2019, In conjunction with the Leaders for Global Operations Program at MIT<br>Cataloged from PDF version of thesis.<br>Includes bibliographical references (page 51).<br>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. Thi
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14

Kumar, Ketan. "Product management framework for the development of automation solutions for biologics drug substance manufacturing." Thesis, Massachusetts Institute of Technology, 2020. https://hdl.handle.net/1721.1/126904.

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Thesis: M.B.A., Massachusetts Institute of Technology, Sloan School of Management, May, 2020<br>Thesis: S.M., Massachusetts Institute of Technology, Department of Chemical Engineering, May, 2020<br>Cataloged from the official PDF of thesis.<br>Includes bibliographical references (pages 119-122).<br>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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15

Wolszon, Zoë. "Improving predictability of cell culture processes during biologics manufacturing scale-up through hybrid modeling." Thesis, Massachusetts Institute of Technology, 2020. https://hdl.handle.net/1721.1/126985.

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Thesis: M.B.A., Massachusetts Institute of Technology, Sloan School of Management, in conjunction with the Leaders for Global Operations Program at MIT, May, 2020<br>Thesis: S.M., Massachusetts Institute of Technology, Department of Electrical Engineering and Computer Science, in conjunction with the Leaders for Global Operations Program at MIT, May, 2020<br>Cataloged from PDF version of thesis.<br>Includes bibliographical references (pages 87-89).<br>In the biotechnology industry, commercial manufacturing of biologic drugs occurs in large-scale production bioreactors (15,000L), but process de
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16

Flores, Ryan Maximiliano. "Design of load-lock door for unit dose continuous lyophilization process for complex biologics." Thesis, Massachusetts Institute of Technology, 2020. https://hdl.handle.net/1721.1/127917.

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Thesis: S.B., Massachusetts Institute of Technology, Department of Mechanical Engineering, May, 2020<br>Cataloged from the official PDF of thesis.<br>Includes bibliographical references (pages 61-62).<br>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 conditions within each respective chamber, a load lock is required. Although load locks are commo
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Khalaf, Elan Adel. "The comparative efficacy of biologics in patients with Crohn´s disease and Ulcerative Colitis." Thesis, Örebro universitet, Institutionen för medicinska vetenskaper, 2019. http://urn.kb.se/resolve?urn=urn:nbn:se:oru:diva-77057.

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Introduction The fundamental concept for modern inflammatory bowel disease (IBD) treatment algorithm is an early induction of mucosal healing and its maintenance. Biological therapies are becoming mainstays of IBD therapy. It is however still unclear if there is a difference between Crohn’s disease (CD) and Ulcerative Colitis (UC) in time from diagnosis to stable maintenance treatment when biological treatment is introduced. Aim To investigate the comparative efficacy of biological agents in CD and UC by studying the time course when biological treatment is introduced. Methods Retrospective st
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Bertoni, Serena <1990&gt. "Design and manufacture of microparticles containing small molecules or biologics for optimized drug release." Doctoral thesis, Alma Mater Studiorum - Università di Bologna, 2019. http://amsdottorato.unibo.it/8903/1/tesi%20dottorato%20Serena_corretta.pdf.

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Oral delivery is the preferred and the most common route of drug administration. This thesis describes the development of innovative oral formulations to overcome poor drug bioavailability, which is currently one of the major challenges in the area of the pharmaceutical research. Microparticles (MPs) were employed to improve the bioavailability of orally administered APIs, differing both from physicochemical properties and therapeutic purposes. Case studies I-II: MPs based on hydrophilic carriers, called Gelucires, successfully improved the oral bioavailability of poorly water soluble drugs. T
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19

Saiz, Balbastre Sandra. "Development and application of analytical techniques for quality control of biologics and sterile pharmaceutical products." Doctoral thesis, Universitat Autònoma de Barcelona, 2019. http://hdl.handle.net/10803/666802.

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El control microbiològic és essencial en la indústria farmacèutica ja que es tracta d’un indicador de la seguretat dels productes. Els mètodes microbiològics utilitzats a les companyies farmacèutiques per analitzar l’ambient del procés de fabricació així com els productes finals estan basats en mètodes de cultiu tradicional. La tecnologia d’aquests mètodes manca de precisió comparada amb les tecnologies més modernes de detecció i identificació microbiològica. Cada vegada, els requeriments dels controls microbiològics de productes i processos són més estrictes, el que fa que es necessiten mèto
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20

LeBrun, Matthew P. "The susceptibility of cell lines used in the production of human biologics to prion infection." Thesis, University of Ottawa (Canada), 2009. http://hdl.handle.net/10393/28095.

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Transmissible spongiform encephalopathies (TSEs) are a group of neurodegenerative human and animal disorders associated with the accumulation of pathogenic or abnormal prion protein (PrPSc) in the brain. Examples include scrapie in sheep and bovine spongiform encephalopathy (BSE) in cattle. Identifying and studying pathogenic prions in vitro has been hampered by a limited capacity to detect abnormal prion proteins and incomplete knowledge of cell lines capable of sustaining a prion infection. This study focused on determining the susceptibility of cells commonly used in the manufacturing proce
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21

Xu, Shuai. "PROMOTING BREAKTHROUGH MEDICAL INNOVATION: INSIGHTS FROM AN ANALYSIS OF RECENT TRANSFORMATIVE DRUGS, BIOLOGICS AND MEDICAL DEVICES." Thesis, Harvard University, 2014. http://etds.lib.harvard.edu/hms/admin/view/54.

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Given the recent concern from multiple healthcare stakeholders that the pipeline of medical innovation is slowing, this thesis provides insights on how to spur breakthrough medical innovation in present day. The findings and recommendations are derived from one of the largest collections of interview transcripts from biomedical innovators (n=143) responsible for developing critical devices, drugs and diagnostics used in medicine today. An exemplary case (coronary artery stent) was selected for an in-depth analysis, which included a detailed recounting of stent development and an exhaustive a
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22

Ibrahim, Ahmad El Cheikh. "Rhabdovirus biologics in plants : reverse engineering of a plant rhabdovirus and production of humanized rabies neutralising antibodies." Thesis, St George's, University of London, 2017. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.719154.

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Although the first successful rabies vaccine administration was in 1885, rabies continues to be the tenth most lethal infection worldwide causing significant human life loss. Endemic to under-developed and developing countries, economic restraints limit the widespread administration of either pre-exposure or post-exposure prophylaxis. This research project is a continuum to the objective of producing rabies vaccine, both its passive and active components, in plants. The main component of this research was the work done to reverse engineer the plant rhabdovirus, Lettuce Yellows Necrotic Virus (
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23

Ouyang, Wei Ph D. Massachusetts Institute of Technology. "Microfluidic platform for rapid biologics activity assessment using molecular charge modulation and electrokinetic concentration based receptor assays." Thesis, Massachusetts Institute of Technology, 2016. http://hdl.handle.net/1721.1/106084.

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Thesis: S.M., Massachusetts Institute of Technology, Department of Electrical Engineering and Computer Science, 2016.<br>Cataloged from PDF version of thesis.<br>Includes bibliographical references (pages 86-91).<br>Biologics (biomolecule drugs) play a key role in modem medicine, yet assuring their quality and safety remains a major challenge for the biopharmaceutical industry. Developing a platform for rapid and reliable assessment of biologics activity is critical for quality control of biologics manufacturing and safety assurance. Herein we introduce a generally applicable platform for this
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ROMEO, ANNA CLAUDIA. "Effectiveness and safety of biologics in pediatric inflammatory bowel disease: Real-life data from the Sicilian Network." Doctoral thesis, Università degli studi di Genova, 2023. https://hdl.handle.net/11567/1105880.

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ABSTRACT Introduction. The incidence and prevalence of pediatric inflammatory bowel disease (IBD) are rising worldwide, with a steep increase in children under 5 years of age. Compared to adult IBD, pediatric IBD presents with a more severe, aggressive phenotype and unique complications, notably growth impairment. The advent of anti–tumor necrosis factor (TNF) α agents has radically modified the management and disease course of IBD, resulting in greater remission and mucosal healing rates, fewer surgeries and hospitalizations, improved quality of life, and, notably for children, correction of
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Ahmed, Mohammed Awad Eltoum. "A retrospective study of patients with biologics treatment at Groote Schuur and Red Cross Children's War Memorial Hospitals." Master's thesis, Faculty of Health Sciences, 2020. http://hdl.handle.net/11427/32432.

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Introduction. The high cost and concern of adverse events, particularly infections, limit the use of biologic disease-modifying anti-rheumatic (bDMARD) therapies. We undertook this retrospective study to document their use for immune-mediated diseases (IMDs) and explore the efficacy, safety, adherence and screening practices prior to initiating bDMARDs in a tertiary referral hospital. Methods. A folder review of all adult and paediatric patients treated for IMDs with bDMARDs at Groote Schuur and Red Cross Hospitals between January 2013 and December 2019. Clinico-demographic particulars, detail
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26

Norlin, Jenny. "Effectiveness and costs of new medical technologies : register-based research in psoriasis." Doctoral thesis, Umeå universitet, Dermatologi och venereologi, 2013. http://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-81899.

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Psoriasis is a chronic, immunological and systemic disease with an estimated prevalence of about 2-3 percent. Psoriasis is associated with the joint disease psoriasis arthropathy. There are several treatments options available for psoriasis and patients with moderate to severe psoriasis generally need systemic agents. In 2004 biologics were introduced for patients with moderate to severe psoriasis in Sweden. The overall objective of this thesis was to assess the relationship between Health Related Quality of Life (HRQOL) and clinical outcome measures in psoriasis patients, to analyse the effec
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Holowacz, Markus, Annika Krans, Camilla Wallén, Alberto Martinez, and Nadia Mohammadi. "A Survey of Commercial Biomolecules, Delimited to Pharmaceuticals and Medical Devices." Thesis, Uppsala universitet, Institutionen för teknikvetenskaper, 2017. http://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-324833.

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Biologics — biomolecule-based therapeutics — are predicted to become the next generation of therapeutical drugs. The pharmaceutical industry is investing a great amount of money into research in this medical field, which shows the importance and the need of analyses regarding biological drugs. This report is a survey of commercial biologics in which the market and trends regarding the past, present and future are analysed. The results are based on a literature study limited to commercial biologics — either as chemical entities, as conjugates to another class of biomolecules or as medical devic
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Martinez, Alberto, Nadia Mohammadi, Markus Holowacz, Annika Krans, and Camilla Wallén. "A Survey of Commercial Biomolecules, Delimited to Pharmaceuticals and Medical Devices." Thesis, Uppsala universitet, Institutionen för teknikvetenskaper, 2017. http://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-324840.

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Biologics — biomolecule-based therapeutics — are predicted to become the next generation of therapeutical drugs. The pharmaceutical industry is investing a great amount of money into research in this medical field, which shows the importance and the need of analyses regarding biological drugs. This report is a survey of commercial biologics in which the market and trends regarding the past, present and future are analysed. The results are based on a literature study limited to commercial biologics — either as chemical entities, as conjugates to another class of biomolecules or as medical devic
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Gregoire, Carrie. "Understanding and increasing Right First Time (RFT) Performance in a production environment: a case study." Thesis, Kansas State University, 2017. http://hdl.handle.net/2097/35812.

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Master of Agribusiness<br>Department of Agricultural Economics<br>Vincent R. Amanor-Boadu<br>It is estimated that the animal health biologics sector will increase by over 27% between 2015 and 2020. This projection and the increasing competition among the sector’s players suggests need to find ways to enhance their efficiencies in manufacturing to sustain their relative competitiveness. One approach to enhancing efficiencies is to ensure that all work is done once, i.e., everything is done right the first time. This research focused on human error as a major source of inefficiency in manufact
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Reichert, Amy. "The Effect of Biologic Materials and Oral Steroids on Radiographic and Clinical Outcomes of Horizontal Alveolar Ridge Augmentation." VCU Scholars Compass, 2018. https://scholarscompass.vcu.edu/etd/5718.

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The purpose of this study was to investigate if the addition of biologic materials and/or oral steroids would affect horizontal bone gain, or the bone density of the grafted bone in horizontal alveolar ridge augmentations. A retrospective chart review was completed to assess the clinical and radiographic outcomes of 53 ridge augmentation patients. An average bone gain of 3.6mm of width was found in our study based on radiographic analysis. There were no statistically significant differences found in the linear bone gain with the addition of biologic materials and steroids. A marginally statist
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Torz, Michal [Verfasser]. "ANA-Titer, Gesamt-IgE-Wert und Plasmablastenaktivität als Prognosefaktoren für das Ansprechen von Biologics bei einer Psoriasis vulgaris / Michal Torz." Greifswald : Universitätsbibliothek Greifswald, 2016. http://d-nb.info/1114668745/34.

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Von, Gehren August Levin. "Entry strategies into biosimilars: assessment of entry modes into the field of biosimilars from the perspective of pharmaceuticals, generics and biologics companies." reponame:Repositório Institucional do FGV, 2013. http://hdl.handle.net/10438/10932.

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Submitted by Levin Gehren (levin.gehren@gmail.com) on 2013-06-24T22:00:43Z No. of bitstreams: 1 Entry_Strategy_into_Biosimilars_LevinGehren_MPGI_Dissertation_2.pdf: 867473 bytes, checksum: 862d9a3ce4489414b000ea43aa461a84 (MD5)<br>Approved for entry into archive by Eliene Soares da Silva (eliene.silva@fgv.br) on 2013-06-25T13:11:58Z (GMT) No. of bitstreams: 1 Entry_Strategy_into_Biosimilars_LevinGehren_MPGI_Dissertation_2.pdf: 867473 bytes, checksum: 862d9a3ce4489414b000ea43aa461a84 (MD5)<br>Made available in DSpace on 2013-06-25T13:14:57Z (GMT). No. of bitstreams: 1 Entry_Strategy_into_Bi
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Wolfgang, Edward William. "A Systems Approach to Understanding the History of U.S. Pediatric Biologic Drug Research and Labeling." Diss., Virginia Tech, 2016. http://hdl.handle.net/10919/71690.

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Using a Systems Theory approach allows a person to analyze the intertwined elements of the drug development system and the potential influences of the environment. Thomas Hughes's Large Technological Systems (LTS) Theory is one that could be used for this purpose; however, it falls short in its ability to address the complexity of current day regulatory environments. This dissertation provides a critical analysis of Hughes's LTS Theory and his phases of evolution as they apply to the United States (U.S.) system for biologic drug research, development and labeling. It identifies and explains po
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Roux, Ilanca. "Prescribing patterns of biologic immunomodulating medicine in the South African private health care sector / Ilanca Roux." Thesis, North-West University, 2010. http://hdl.handle.net/10394/4936.

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Advances in molecular immunology and rapid technical evolution during the past two decades have led to a new class of medicines called biologics. Recently, a large number of biologics, or biologic immunomodulators, directed towards an array of immune–mediated diseases, have entered the market. This has lead to a dramatic change in the immunotherapy of autoimmune diseases, as biologics present new potential to improve or substitute conventional immunosuppressive therapies. According to literature, biologics are used by only a small number of a health plan’s members, (approximately one per cent)
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Lemström, Heidi. "Investigation and optimization of elution buffer effects on the elution profile for the cation exchange chromatography resin POROS XS : In association with Cobra Biologics." Thesis, KTH, Skolan för bioteknologi (BIO), 2016. http://urn.kb.se/resolve?urn=urn:nbn:se:kth:diva-214684.

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The goal of this project was to investigate how elution buffer properties affectthe protein elution in the polishing purification step with a cation exchange chromatographyconsisting of POROS XS resin. Hence be able to better predict thebehavior of the resin, two model proteins were used for this investigation (K100and Y102). This project included lab experiments (small scale), and design ofexperiments using MODDE software to evaluate the optimal conditions. Thefactors pH, conductivity, sample load and buffer concentration were investigatedon antibody Y102 while only pH and conductivity were i
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Obeng, Joyce Afrakoma. "Predictors of response to biologics and to a small molecule Inhibitor of prolyl hydroxylase-3 treatments in rheumatoid arthritis and in breast cancer respectively." Doctoral thesis, Università del Piemonte Orientale, 2018. http://hdl.handle.net/11579/104064.

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Lange, Markus Reiner [Verfasser], Armin [Akademischer Betreuer] Koch, and Ulrich [Akademischer Betreuer] Kalinke. "Design and analysis of clinical trials with biologics using dose-time-response models / Markus Reiner Lange ; Akademische Betreuer: Armin Koch, Ulrich Kalinke ; Institut für Biometrie." Hannover : Bibliothek der Medizinischen Hochschule Hannover, 2018. http://d-nb.info/1173465138/34.

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Kornecki, Martin Lukas [Verfasser], Jochen [Akademischer Betreuer] Strube, and Udo [Akademischer Betreuer] Rau. "Methoden zur Integration von Upstream und Downstream Processing für Biologics hinsichtlich Prozessentwicklung, Digital Twin und Process Analytical Technology / Martin Lukas Kornecki ; Jochen Strube, Udo Rau." Clausthal-Zellerfeld : Technische Universität Clausthal, 2020. http://d-nb.info/1231362537/34.

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Fabre, Sylvie. "Rémission de la polyarthrite rhumatoïde : apport des biomarqueurs et du mode d'administration des biothérapies." Thesis, Montpellier 1, 2012. http://www.theses.fr/2012MON1T027/document.

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Dans la prise en charge de la polyarthrite rhumatoïde (PR), l’identification de biomarqueurs associés à un diagnostic, un pronostic mais surtout à une bonne réponse thérapeutique est un des enjeux de la prochaine décennie, d’autant que de nombreux outils sont maintenant disponibles grâce à l’étude du génome, du transcriptome et du protéome. Au cours de mon travail de thèse, je me suis intéressée à l’identification de différentes classes de biomarqueurs prédictifs de la réponse au traitement par biothérapies.Tout d’abord par une approche protéomique, j’ai identifié une combinaison de biomarqueu
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Steve, Donna L. "Analytical techniques used in the development of quantitative and qualitative assays for pharmaceutical and biological products in animal health." Kansas State University, 2017. http://hdl.handle.net/2097/35491.

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Master of Science in Biomedical Sciences<br>Department of Diagnostic Medicine/Pathobiology<br>Alison P. Adams<br>The animal health industry is a growing industry. Owners of pets and other animals want to ensure their animals are healthy. To do this, the animal health industry markets a variety of products from pharmaceutical products, such as antibiotics, to biological products, such as vaccines. These products are developed and marketed after the company provides regulators the necessary information as guided by a set of regulations. Pharmaceutical products follow Title 21 of the Code of Fede
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Czuba, Elodie. "Développement de nouveaux systèmes nanoparticulaires pour l'administration de bio-médicaments par voie orale." Thesis, Strasbourg, 2018. http://www.theses.fr/2018STRAJ072/document.

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Les bio-médicaments sont aujourd’hui confrontés à un manque d’adhésion thérapeutique due principalement à leur voie d’administration parentérale. Pour pallier à cela, un système de double encapsulation composé d’une gélule gastro-résistante renfermant un système de nanoparticules (NPs) polymériques à base de PLGA a été développé apportant protection et absorption pour in fine une administration par voie orale. L’objectif de ce travail a été de mettre au point le système de NPs renfermant de l’insuline, en jouant sur la charge de surface afin d’augmenter la biodisponibilité. Ainsi, nous avons m
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Ferlin, Maria. "Biologisk mångfald i läroböcker i biologi." Doctoral thesis, Högskolan i Borås, Institutionen för Pedagogik, 2014. http://urn.kb.se/resolve?urn=urn:nbn:se:hb:diva-3706.

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The aim of this thesis is to analyse offered meaning, that is, what and how subject content is communicated to the recipients. In this case the subject content is biological diversity and the communicative artefacts are biology books for the latter grades in the Swedish compulsory school. The four papers cover aspects of biodiversity in biology books (I), connections between biology books and the world outside school (II), the definition of the species concept and the use of the concept species in textbooks and in pupils' assertions (III), and finally how instances of modes are connected in a
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Bocquet, François. "Médicaments biosimilaires : quels enjeux économiques et politiques ?" Thesis, Paris 9, 2014. http://www.theses.fr/2014PA090038.

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Après les médicaments génériques, copies de médicaments d’origine chimique, c’est désormais le marché des médicaments biologiques qui s’ouvre à la concurrence de « copies » avec les bio-similaires. De nombreuses incertitudes demeurent concernant l’essor de ce marché aujourd’hui émergent et la capacité des bio-similaires à entrer en compétition avec les autres bio-médicaments innovants.Comme dans le cas des génériques, l’objectif avec les bio-similaires est d’assurer un accès optimal et équitable des patients à des traitements aussi efficaces et sûrs d’utilisation que leurs médicaments de référ
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Jackson, JeShaune D. Jackson. "Bench to Bone: Commercializing a Cellular Therapeutic for Regenerative Medicine." Case Western Reserve University School of Graduate Studies / OhioLINK, 2018. http://rave.ohiolink.edu/etdc/view?acc_num=case1521472107740449.

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Austin, Brittany Logan. "A Biomechanical Investigation of Collagen, Platelet-rich Plasma, and Mesenchymal Stromal Cells on the Achilles Tendon in a Rat Model." Youngstown State University / OhioLINK, 2019. http://rave.ohiolink.edu/etdc/view?acc_num=ysu155905140840335.

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Hamann, Philip. "An investigation into the predictors and frequency of sustained remission in patients with rheumatoid arthritis undergoing treatment with anti-tumour necrosis factor therapy using the British Society for Rheumatology Biologics Register for Rheumatoid Arthritis." Thesis, University of Bath, 2018. https://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.760961.

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Background. Response to anti-tumour necrosis factor (anti-TNF) therapy in patients with rheumatoid arthritis (RA) varies between patients. Incidence of sustained remission in the UK is not known, and factors contributing to its achievement are poorly understood. Prior knowledge of response would enable better targeting of anti-TNF therapy, leading to better outcomes and reduced morbidity. Aims. This thesis aims to identify incidence of sustained remission and low disease activity (LDA) in patients with rheumatoid arthritis (RA) taking anti-TNF therapy. Clinical and demographic factors associat
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Coulet, Mathilde. "Compréhension de la croissance des cellules de mammifères dans des environnements contraints et mécanismes de sécrétion." Electronic Thesis or Diss., université Paris-Saclay, 2023. http://www.theses.fr/2023UPASL040.

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Depuis 1982 et l'approbation de l'insuline recombinante, les produits biothérapeutiques occupent une place grandissante parmi les nouveaux médicaments autorisés par la Food and Drug Administration (FDA). Plus particulièrement, les anticorps monoclonaux (mAbs) sont devenus majoritaires et représentent aujourd'hui plus de 50% des approbations parmi les produits biothérapeutiques aux Etats-Unis et en Europe. Ces mAbs sont produits majoritairement dans des cellules de Mammifères capables d'effectuer des modifications post-traductionnelles bien caractérisées et compatibles avec une efficacité théra
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Santos, Gustavo Souza. "Biomonitoramento das Baías de Guaratuba e Paranaguá através de biomarcadores de contaminação ambiental." reponame:Repositório Institucional da UFPR, 2013. http://hdl.handle.net/1884/29826.

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Resumo: Os estuários são muitas vezes referidos como o tipo de habitat mais degradado do mundo. São vulneráveis a diversas perturbações causadas por atividades humanas, incluindo a agricultura, a indústria, os assentamentos humanos, a pesca e as atividades portuárias. O estuário de Guaratuba é afetado principalmente pelo desenvolvimento das atividades agrícolas e pelas modificações hidrológicas provenientes da construção de barragens. Já o complexo estuarino de Paranaguá recebe regularmente escoamentos provenientes do Porto, de indústrias locais e atividades agrícolas, além do esgoto doméstico
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Degboé, Yannick. "Modulation thérapeutique du phénotype du macrophage dans la polyarthrite rhumatoïde." Thesis, Toulouse 3, 2018. http://www.theses.fr/2018TOU30085/document.

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La polyarthrite rhumatoïde (PR) est le rhumatisme inflammatoire chronique le plus fréquent. Cette maladie est caractérisée par une auto-immunité et une synovite hypertrophique, responsables d'une destruction des articulations périphériques. Les macrophages contribuent aux phénomènes inflammatoires de la PR. Ces cellules peuvent présenter différents états d'activation ou " polarisation ", réversibles, dépendant de leur environnement, notamment cytokinique. Les biothérapies (bDMARDs) ont représenté une avancée majeure dans la prise en charge des manifestations inflammatoires des formes sévères d
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Roche, Mélanie. "Stratégies innovantes pour le radiomarquage de macro-biomolécules au fluor-18 pour des applications en imagerie moléculaire in vivo." Thesis, Université Paris-Saclay (ComUE), 2018. http://www.theses.fr/2018SACLS031/document.

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Le radiomarquage des macro-biomolécules au fluor-18 représente un défi majeur en radiochimie vu leur importance en imagerie moléculaire. Les macro-biomolécules et en particulier les peptides offrent une diversité moléculaire et un ciblage in vivo souvent plus spécifiques et sélectifs que les molécules de plus faibles poids moléculaires. Cependant, les conditions standards de radiomarquage au fluor-18 seraient destructrices pour de tels composés et ne peuvent être utilisées directement. Peu de méthodes directes de radiomarquage existent et présentent certains inconvénients (température encore é
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