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dc.contributor.advisorJiménez Cruz, Ronald Andrés, dir.spa
dc.contributor.authorJaimes Vega, Nathalia Andreaspa
dc.contributor.authorJiménez Cruz, Ronald Andrésspa
dc.date.accessioned2020-02-11T16:27:24Zspa
dc.date.available2020-02-11T16:27:24Zspa
dc.date.issued2019spa
dc.identifier.urihttps://repository.udca.edu.co/handle/11158/2748spa
dc.description76 páginas : gráficas, ilustracionesspa
dc.description.abstractEsta investigación busca analizar el aporte del Químico Farmacéutico en el desarrollo de productos de terapias avanzadas en Colombia, identificar los principales desafíos a nivel regulatorio para la implementación de productos de terapiasspa
dc.format.mimetypeapplication/pdfspa
dc.language.isospaspa
dc.publisherBogotá : Universidad de Ciencias Aplicadas y Ambientales, 2019spa
dc.rightsDerechos Reservados - Universidad de Ciencias Aplicadas y Ambientalesspa
dc.rights.urihttps://creativecommons.org/licenses/by-nc-sa/4.0/spa
dc.subject.meshTerapéuticaspa
dc.subject.meshCélulas Madrespa
dc.titleAporte del químico farmacéutico a los desafíos relacionados con el desarrollo de productos de terapias avanzadas en Colombiaspa
dc.typeTrabajo de grado - Pregradospa
dc.rights.accessrightsinfo:eu-repo/semantics/openAccessspa
dc.subject.lembQuímicos farmacéuticosspa
dc.description.notesIncluye bibliografíaspa
dc.identifier.localQF031 J13a 2019 (205833)spa
dc.relation.referencesAbbasalizadeh, S., & Baharvand, H. (2013). Technological progress and challenges towards cGMP manufacturing of human pluripotent stem cells based therapeutic products for allogeneic and autologous cell therapies. Biotechnology Advances, 31(8), 1600-1623. https://doi.org/10.1016/j.biotechadv.2013.08.009spa
dc.relation.referencesAnatol, R., Arcidiacono, J., Bailey, A. M., Durfor, C. N., Fink, D. W., Holobaugh, P., … Witten, C. (2014). The Regulatory Process from Concept to Market. Principles of Tissue Engineering (Fourth Edition). Elsevier. https://doi.org/10.1016/B978-0-12-398358-9.00086-0spa
dc.relation.referencesAtala, A. (2019). Principles of Tissue Engineering. Campbell-Walsh Urology (Eleventh E). Elsevier Inc. https://doi.org/10.1016/B978-1-4557-7567-5.00020-0spa
dc.relation.referencesAusubel, Lara J. Lopez, P. M., & Couture, L. A. (2011). GMP Scale-Up and Banking of Pluripotent Stem Cells for Cellular Therapy Applications. Human Pluripotent Stem Cells, 767, 147-159spa
dc.relation.referencesAyala, L. A. (2007). Medicina regenerativa y enfermedades cardiovasculares: Terapia con células madre, 5(2), 38-41.spa
dc.relation.referencesBaghbaderani, B. A., Tian, X., Neo, B. H., Burkall, A., Dimezzo, T., Sierra, G., … Rao, M. S. (2015). Stem Cell Reports. Stem Cell Reports, 5(4), 647-659. https://doi.org/10.1016/j.stemcr.2015.08.015spa
dc.relation.referencesBall, O., Robinson, S., Bure, K. I. M., Brindley, D. A., & Mccall, D. (2018). Bioprocessing automation in cell therapy manufacturing : Outcomes of special interest group automation workshop. Cytotherapy, 20(4), 592-599. https://doi.org/10.1016/j.jcyt.2018.01.005spa
dc.relation.referencesBravery, C. A., Carmen, J., Fong, T., Oprea, W., Hoogendoorn, K. H., Woda, J., … Hof, W. V. A. N. T. (2013). Potency assay development for cellular therapy products : an ISCT * review of the requirements and experiences in the industry. Journal of Cytotherapy, 15(1), 9-19.e9. https://doi.org/10.1016/j.jcyt.2012.10.008spa
dc.relation.referencesBrien, F. J. O. (2011). Biomaterials & scaffolds for tissue engineering. Materials Today, 14(3), 88-95. https://doi.org/10.1016/S1369-7021(11)70058-Xspa
dc.relation.referencesBuckler, R. L. E. E., Kunkel, E. J., Thompson, M. L., & Ehrhardt, R. O. (2016). Technological developments for small-scale downstream processing of cell therapies. Cytotherapy, 18(3), 301-306. https://doi.org/10.1016/j.jcyt.2015.12.003spa
dc.relation.referencesCalmels, B., Mfarrej, B., & Chabannon, C. (2018). From clinical proof-of-concept to commercialization of CAR T cells. Drug Discovery Today, 23(4), 758-762. https://doi.org/10.1016/j.drudis.2018.01.024spa
dc.relation.referencesCarreras, E. (2016). Guía del Trasplante de Médula Óseaspa
dc.relation.referencesChaparro, O., Ph, D., Beltrán, O., & Sc, M. (2009). REPROGRAMACIÓN NUCLEAR Y CÉLULAS Introducción. Med, 17(2), 252-263.spa
dc.relation.referencesCorbett, M. S., Webster, A., Hawkins, R., & Woolacott, N. (2017). Innovative regenerative medicines in the EU : a better future in evidence ?, 1-8. https://doi.org/10.1186/s12916-017-0818-4spa
dc.relation.referencesCuende, N., Rasko, J. E. J., & Koh, M. B. C. (2018). Cell , tissue and gene products with marketing authorization in 2018 worldwide. Cytotherapy, 20(11), 1401- 1413. https://doi.org/10.1016/j.jcyt.2018.09.010spa
dc.relation.referencesDetela, G., & Lodge, A. (2016). Manufacturing process development of ATMPs within a regulatory framework for EU clinical trial & marketing authorisation applications. Cell and gene therapy insights, 425-452. https://doi.org/10.18609/cgti.2016.056spa
dc.relation.referencesDeusen, A. L. Van. (2016). 6 - Compatibility of GxP with Existing Cell Therapy Quality Standards. Guide to Cell Therapy GxP. Elsevier Inc. https://doi.org/10.1016/B978-0-12-803115-5.00006-1spa
dc.relation.referencesDotti, G., & Brenner, M. K. (2019). Chapter 100 - T-Cell Therapy of Hematologic Diseases. En Hematology (Seventh Ed, pp. 1568-1574). Elsevier Inc. https://doi.org/10.1016/B978-0-323-35762-3.00100-1spa
dc.relation.referencesDuvall, C. L., Gersbach, C. A., & Davidson, J. M. (2014). Gene Delivery into Cells and Tissues. https://doi.org/10.1016/B978-0-12-398358-9.00035-5spa
dc.relation.referencesEaker, S., Abraham, E., Allickson, J., Brieva, T. A., Baksh, D., Heathman, T. R. J., … Zhang, N. A. N. (2017). Bioreactors for cell therapies : Current status and future advances. Cytotherapy, 19(1), 9-18. https://doi.org/10.1016/j.jcyt.2016.09.011spa
dc.relation.referencesFernández Collado, C., & Baptista Lucio, P. (2014). Metodología de la Investigación. (McGrawHill, Ed.) (6a ed.). México, D.F.spa
dc.relation.referencesFoss, D. V, Hochstrasser, M. L., & Wilson, R. C. (2018). Clinical applications of CRISPR-based genome editing and diagnostics. Transfusion, 0, 1-11. https://doi.org/10.1111/trf.15126spa
dc.relation.referencesFreimark, D., Pino-Grace, P.-, Pohl, S., Weber, C., Wallrapp, C., & Geigle, P. (2010). Use of encapsulated stem cells to overcome the bottleneck of cell availability for cell therapy approaches. Transfusion Medicine Hemotherapy, 37, 66-73.spa
dc.relation.referencesFundación Mencía. (2017). Fundación Mencía. Recuperado a partir de http://www.fundacionmencia.org/es/enfermedades-geneticas/terapia-genica/spa
dc.relation.referencesFurth, M. E., Atala, A., Innovations, W. F., & Carolina, N. (2014). Tissue Engineering : Future Perspectives. Principles of Tissue Engineering (Fourth Edition). Elsevier. https://doi.org/10.1016/B978-0-12-398358-9.00006-9spa
dc.relation.referencesGarcía, S. C. (2012). Gen ajeno o exógeno : transgén, 4, 187-199.spa
dc.relation.referencesGavin, D. K., & Ph, D. (s. f.). Advanced Topics : Successful Development of Quality Cell and Gene Therapy Products Division of Cellular and Gene Therapies.spa
dc.relation.referencesGee, A. P. (2009). Cell therapy: cGMP Facilities and Manufacturing. (A. P. Gee, Ed.) (1.a ed.). Houston, TX: Springer US. https://doi.org/10.1007/b102110spa
dc.relation.referencesGee, A. P. (2019). Chapter 97 - Graft Engineering and Cell Processing. Hematology (Seventh Ed). Elsevier Inc. https://doi.org/10.1016/B978-0-323-35762-3.00097- 4spa
dc.relation.referencesGilbert, T. W., Sellaro, T. L., & Badylak, S. F. (2006). Decellularization of tissues and organs. Biomaterials, 27, 3675-3683. https://doi.org/10.1016/j.biomaterials.2006.02.014spa
dc.relation.referencesGuzmán Cruz, J. H., & Otálvaro Cifuentes, E. H. (2016). PERSPECTIVA DE TERAPIAS AVANZADAS EN EL MARCO NORMATIVO. Cartagena: INVIMA.spa
dc.relation.referencesHernández Ramírez, P. (2006). Medicina regenerativa II. Aplicaciones, realidad y perspectivas de la terapia celular. Revista Cubana de Hematología, Inmunología y Hemoterapia, 22(1). Recuperado a partir de http://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S0864- 02892006000100002spa
dc.relation.referencesHildebrand, M., & Hochschule, M. (2011). Manufacture of advanced therapies : Academia meets industry, 8(7), 9-10spa
dc.relation.referencesHouse of Lords Science and Technology Committee. (2013). Regenerative medicine report. London.spa
dc.relation.referencesHuman, T. H. E., Stem, E., Human, T. H. E., & Germ, E. (1998). THE HUMAN EMBRYONIC STEM CELL AND, 11-22spa
dc.relation.referencesIglesias-lópez, C., Agustí, A., Obach, M., & Vallano, A. (2019). Regulatory Framework for Advanced Therapy Medicinal Products in Europe and United States, 10(August), 1-14. https://doi.org/10.3389/fphar.2019.00921spa
dc.relation.referencesIyer, R. K., Bowles, P. A., Kim, H., & Dulgar-tulloch, A. (2018). Industrializing Autologous Adoptive Immunotherapies : Manufacturing Advances and Challenges, 5(May), 1-9. https://doi.org/10.3389/fmed.2018.00150spa
dc.relation.referencesJones, J. (2005). Scaffolds for tissue engineering. En Biomaterials, artificial organs and tissue engineering (pp. 201-214). https://doi.org/10.1533/9781845690861.4.201spa
dc.relation.referencesKalra, K., & Tomar, P. C. (s. f.). Stem Cell : Basics , Classification and Applicationsspa
dc.relation.referencesKarginov, F., & Hannon, G. (2010). The CRISPR System: Small RNA-Guided Defense in Bacteria and Archaea Molecular Cell. Molecular Cell, 37(1), 7-19. https://doi.org/10.1016/j.molcel.2009.12.033spa
dc.relation.referencesKhademhosseini, A., Karp, J. M., Gerecht-nir, S., Ferreira, L., Annabi, N., Sirabella, D., & Vunjak-novakovic, G. (2014). Embryonic Stem Cells as a Cell Source for Tissue Engineering. Principles of Tissue Engineering (Fourth Edition). Elsevier. https://doi.org/10.1016/B978-0-12-398358-9.00032-Xspa
dc.relation.referencesKulinets, I. (2015). Biomaterials and their applications in medicine. En Regulatory Affairs for Biomaterials and Medical Devices (pp. 1-10). Woodhead Publishing Limited. https://doi.org/10.1533/9780857099204.1spa
dc.relation.referencesLindblad, R., Mondoro, T. H., & Wood, D. (2019). INVESTIGATIONAL NEW DRUG – ENABLING PROCESSES FOR CELL-BASED THERAPIES. Hematology (Seventh Ed). Elsevier Inc. https://doi.org/10.1016/B978-0-323- 35762-3.00096-2spa
dc.relation.referencesLowry, W. E., & Quan, W. L. (2010). Roadblocks en route to the clinical application of induced pluripotent stem cells. Journal of Cell Science, 123, 643-651.spa
dc.relation.referencesMa, R., Schaer, M., Hogan, M., Demange, M., & Rodeo, S. A. (2019). Orthobiologics : Clinical Application of Platelet-Rich Plasma and Stem Cell Therapy. DeLee, Drez, and Miller’s Orthopaedic Sports Medicine (Fourth Edi). Elsevier Inc. https://doi.org/10.1016/B978-1-4557-4376-6.00005-6spa
dc.relation.referencesManuscript, A. (2013). NIH Public Access, 18(3), 217-222. https://doi.org/10.1111/j.1601-0825.2011.01870.x.Thespa
dc.relation.referencesMaría, D., & Ibarz, T. (s. f.). Desafíos en la Regulación de Nuevos Productos Biológicos : Terapia Génica , Celular y Tisular Terapia Génica , Celular y Tisular Estrategias terapéuticas innovadoras que ofrecen nuevas oportunidades para algunas enfermedades que carecen de.spa
dc.relation.referencesMarketsandMarkets. (2019). Regenerative Medicine Market by Type. USspa
dc.relation.referencesMartin, G. (1981). Isolation of a pluripoten cell line from early mouse embryos cultured in medium conditioned by teratocarcinoma stem cells. Proc. Natl Acad. Sci. USA, 78.spa
dc.relation.referencesMartin, U. (2017). Therapeutic Application of Pluripotent Stem Cells : Challenges and Risks, 4(December). https://doi.org/10.3389/fmed.2017.00229spa
dc.relation.referencesMason, C., & Brindley, D. A. (2011). Cell therapy industry : billion dollar global business with unlimited potential E ditorial. Regenerative Medicine, 6(3), 265- 272spa
dc.relation.referencesMoffat, K. L., Neal, R. A., Freed, L. E., & Guilak, F. (2014). Engineering Functional Tissues : In Vitro Culture Parameters. Principles of Tissue Engineering (Fourth Edition). Elsevier. https://doi.org/10.1016/B978-0-12-398358-9.00013-6spa
dc.relation.referencesMorrow, D., Ussi, A., & Migliaccio, G. (2017). Addressing Pressing Needs in the Development of Advanced therapies, 5(September), 1-6. https://doi.org/10.3389/fbioe.2017.00055spa
dc.relation.referencesMulet, J., & Cance, P. (s. f.). Development of Advanced Therapy Medicinal Products in Europe. BlueReg Pharma Consultingspa
dc.relation.referencesNaldini, L. (2011). Ex vivo gene transfer and correction for cell-based therapies. Nature Publishing Group, 12(5), 301-315. https://doi.org/10.1038/nrg2985spa
dc.relation.referencesNational Institue of Health. (2019). Clinical Trials. Recuperado a partir de https://clinicaltrials.gov/ct2/homespa
dc.relation.referencesNIH. (s. f.). Recuperado a partir de https://www.cancer.gov/publications/dictionaries/cancerterms/def/hematopoietic-stem-cellspa
dc.relation.referencesNIH, N. I. of H. (2015). Stem Cell Basics.spa
dc.relation.referencesOliveira, E. P., Silva-correia, J., & Reis, R. L. (2018). Biomaterials Developments for Brain Tissue Engineering.spa
dc.relation.referencesOsorio-Delgado, M. A., Henao-Tamayo, L. J., Velásquez-Cock, J. A., CañasGutiérrez, A. I., Restrepo-Múnera, L. M., Gañán-Rojo, P. F., … Castro-Herazo, C. I. (2017). Biomedical applications of polymeric biomaterials • Aplicaciones biomédicas de biomateriales poliméricos. DYNA, 84(201), 241-252. https://doi.org/http://dx.doi.org/10.15446/dyna.v84n201.60466spa
dc.relation.referencesPereira, T. D., Moncaubeig, F., & Farid, S. S. (2018). Impact of allogeneic stem cell manufacturing decisions on cost of goods , process robustness and reimbursement. Biochemical Engineering Journal, 137, 132-151. https://doi.org/10.1016/j.bej.2018.04.017spa
dc.relation.referencesPicó, Y., Farré, M., Kantiani, L., & Barceló, D. (2012). Microfluidic Devices: Biosensors. Chemical Analysis of Food: Techniques and Applications, 177-217. https://doi.org/10.1016/B978-0-12-384862-8.00007-8spa
dc.relation.referencesResearch and Markets. (2019). Global Market for Cell Therapy & Tissue Engineering 2019. Recuperado a partir de https://www.researchandmarkets.com/reports/4767224/market-for-cell-therapyand-tissueengineering?utm_source=GN&utm_medium=PressRelease&utm_code=w64bt5 &utm_campaign=1240202+- +Global+Market+for+Cell+Therapy+%26+Tissue+Engineering%2C+2019%3A +The+Arrival+of+Regenerative+Medicine+(RM)+has+been+Propelled+by+Ad vances+Across+the+Cell+Therapy+(CT)+and+Tissue+(TE)+Engineering+Indus tries&utm_exec=joca220prdspa
dc.relation.referencesRoa Ramirez, Derly Alexandra; Quitian Ayala, R. del P. (2016). SITUACIÓN ACTUAL DE LA INGENIERIA DE TEJIDOS Y MEDICINA REGENERATIVA EN COLOMBIA. Universidad de Ciencias Aplicadas y Ambientales (UDCA).spa
dc.relation.referencesRodríguez, E. D. E. D., Peña, A. V., Edreira, A. R., García, B. M., Infiesta, A. M., & Llames, S. G. (2004). ESTADO ACTUAL DE LA INGENIERIA DE TEJIDOS EN UROLOGÍA. REVISIÓN DE LA LITERATURA. Actas Urológicas Españolas, 28(9), 636-645.spa
dc.relation.referencesScienceDirect. (s. f.). Recuperado a partir de https://www.sciencedirect.com/topics/neuroscience/bioreactorsspa
dc.relation.referencesSlack, J. M. W. (2014). Molecular Biology of the Cell. Principles of Tissue Engineering (Fourth Edition). Elsevier. https://doi.org/10.1016/B978-0-12- 398358-9.00007-0spa
dc.relation.referencesSolomon, J., Csontos, L., Clarke, D., Bonyhadi, M., Zylberberg, C., Mcniece, I. A. N., … Deans, R. (2016). Current perspectives on the use of ancillary materials for the manufacture of cellular therapies. Cytotherapy, 18(1), 1-12. https://doi.org/10.1016/j.jcyt.2015.09.010spa
dc.relation.referencesSpector, M. (2006). Biomaterials-based tissue engineering and regenerative medicine solutions to musculoskeletal problems. Swiss Med Wkly, 136, 293-302.spa
dc.relation.referencesStockdale, F. E. (2014). Gene Expression , Cell Determination , and Differentiation. Principles of Tissue Engineering (Fourth Edition). Elsevier. https://doi.org/10.1016/B978-0-12-398358-9.00012-4spa
dc.relation.referencesSuárez, J., & Herreros, D. L. (s. f.). Tratamiento Regenerativo en Pacientes con Infarto de Miocardio Anterior Extenso con Infarto de Miocardio Anterior Extenso Tratamiento Regenerativo en Pacientes.spa
dc.relation.referencesTakebe, T., Sekine, K., Kimura, M., Yoshizawa, E., Ayano, S., Koido, M., … Taniguchi, H. (2017). Massive and Reproducible Production of Liver Buds Entirely from Human Pluripotent Stem Cells Report Massive and Reproducible Production of Liver Buds Entirely from Human Pluripotent Stem Cells. CellReports, 21(10), 2661-2670. https://doi.org/10.1016/j.celrep.2017.11.005spa
dc.relation.referencesTakeda, H., Dondzillo, A., Randall, J. A., & Gubbels, S. P. (2019). Challenges in Cell-Based Therapies for the Treatment of Hearing Loss. Trends in Neurosciences, 41(11), 823-837. https://doi.org/10.1016/j.tins.2018.06.008spa
dc.relation.referencesTavira Montalván, C. A., Ortega García, A., Dávila González, I., Estrada Moncada, S., & Meneses Acosta, A. (2009). Alcances y perspectivas del cultivo de células animales en la biotecnología farmacéutica Animal cell culture in pharmaceutical biotechnology : research and perspectives. Revista Mexicana de Ciencias Farmacéuticas, 40(4).spa
dc.relation.referencesU.S Department of Health and Human Services. (2019). National Institutes of Health Recuperado a partir de https://stemcells.nih.gov/info/basics.htmspa
dc.relation.referencesUnited States Adopted Names. (2016). American Medical Association. Recuperado a partir de https://www.ama-assn.org/about/united-states-adopted-names/cellularnoncellular-therapies-naming-schemespa
dc.relation.referencesWorgall, S., & Crystal, R. G. (2014). Gene Therapy. Principles of Tissue Engineering (Fourth Edition). Elsevier. https://doi.org/10.1016/B978-0-12-398358-9.00034-3spa
dc.relation.referencesYu, J., & Thomson, J. A. (2001). 1. embryonic stem cells, 1-12.spa
dc.relation.referencesZafar, M. S., Ullah, R., Qamar, Z., Fareed, M. A., Amin, F., Khurshid, Z., & Sefat, F. (2019). Properties of dental biomaterials. En F. S. Zohaib Khurshid, Shariq Najeeb, Muhammad Sohail Zafar (Ed.), Advanced Dental Biomaterials (1.a ed., pp. 7-35). Woodhead Publishing Limited. https://doi.org/https://doi.org/10.1016/B978-0-08-102476-8.00002-5spa
dc.relation.referencesZakrzewski, W., Dobrzy, M., Szymonowicz, M., & Rybak, Z. (2019). Stem cells : past , present , and future, 5, 1-22.spa
dc.relation.referencesZhou, W., & Kantardjieff, A. (s. f.). Mammalian Cell Cultures for Biologics Manufacturing.spa
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dc.description.degreenameQuímico(a) Farmacéuticospa
dc.publisher.facultyFacultad de Cienciasspa
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