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Batch-to-batch reproducibility of Transferon (TM)

dc.creatorMedina-Rivero, Emilio
dc.creatorMerchand-Reyes, Giovanna
dc.creatorPavón, Lenin
dc.creatorVázquez-Leyva, Said
dc.creatorPérez-Sánchez, Gilberto
dc.creatorSalinas-Jazmín, Nohemí
dc.creatorEstrada-Parra, Sergio
dc.creatorVelasco-Velázquez, Marco
dc.creatorPérez-Tapia, Sonia Mayra
dc.date.accessioned2017-06-30T03:52:00Z
dc.date.available2017-06-30T03:52:00Z
dc.date.issued2014es_ES
dc.identifier2337es_ES
dc.identifier.issn0731-7085es_ES
dc.identifier.urihttp://repositorio.inprf.gob.mx/handle/123456789/6982
dc.identifier.urihttps://doi.org/10.1016/j.jpba.2013.09.004es_ES
dc.language.isoenges_ES
dc.publisherELSEVIER SCIENCE BV, PO BOX 211, 1000 AE AMSTERDAM, NETHERLANDSes_ES
dc.relation88, 289-294 p.es_ES
dc.relationversión del editores_ES
dc.rightsacceso cerradoes_ES
dc.titleBatch-to-batch reproducibility of Transferon (TM)es_ES
dc.typearticlees_ES
dc.contributor.affiliationInst Politecn Nacl, Escuela Nacl Ciencias Biol, Unidad Desarrollo & Invest Bioproc UDIBI, Plan Ayala S-N Colonia Casco Santo Tomas, Mexico City 01134, DF, Mexico.es_ES
dc.contributor.emailcipft.encb@gmail.comes_ES
dc.relation.jnabreviadoJ PHARM BIOMED ANALes_ES
dc.relation.journalJournal of pharmaceutical and biomedical analysises_ES
dc.identifier.placeAmsterdames_ES
dc.date.published2014es_ES
dc.identifier.organizacionInstituto Nacional de Psiquiatría Ramón de la Fuente Muñizes_ES
dc.identifier.eissn1873-264Xes_ES
dc.identifier.doi10.1016/j.jpba.2013.09.004es_ES
dc.description.monthEnees_ES
dc.description.abstractotrodiomaHuman dialyzable leukocyte extracts (DLEs) are heterogeneous mixtures of low-molecular-weight peptides that modulate immune responses in various diseases. Due their complexity, standardized methods to identify their physicochemical properties and determine that production batches are biologically active must be established. We aimed to develop and validate a size exclusion ultra performance chromatographic (SE-UPLC) method to characterize Transferon (TM), a DLE that is produced under good manufacturing practices (GMPs). We analyzed an internal human DLE standard and 10 representative batches of Transferon (TM), all of which had a chromatographic profile characterized by 8 main peaks and a molecular weight range between 17.0 and 0.2 kDa. There was high homogeneity between batches with regard to retention times and area percentages, varying by less than 0.2% and 30%, respectively, and the control chart was within 3 standard deviations. To analyze the biological activity of the batches, we studied the ability of Transferon (TM) to stimulate IFN-gamma production in vitro. Transferon (TM) consistently induced IFN-gamma production in Jurkat cells, demonstrating that this method can be included as a quality control step in releasing TransferonTm batches. Because all analyzed batches complied with the quality attributes that were evaluated, we conclude that the DLE TransferonTm is produced with high homogeneity. (C) 2013 The Authors. Published by Elsevier B.V. All rights reserved.es_ES
dc.subject.kwExtractos dializable de leucocitoses_ES
dc.subject.kwCromatografía líquida de ultra-desempeñoes_ES
dc.subject.kwCLUDes_ES
dc.subject.kwEspecificaciones de calidades_ES
dc.subject.kwGamma interferónes_ES
dc.subject.kwTransferones_ES
dc.subject.koDialyzable leukocyte extractses_ES
dc.subject.koUPLCes_ES
dc.subject.koUltra-Performance Liquid Chromatographyes_ES
dc.subject.koQuality specificationses_ES
dc.subject.koIFN-gammaes_ES
dc.subject.koTransferones_ES


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