Validation of a cell proliferation assay to assess the potency of a dialyzable leukocyte extract intended for batch release

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dc.contributor.affiliationUnidad de Desarrollo e Investigación en Bioprocesos (UDIBI), Escuela Nacional de Ciencias Biológicas, Instituto Politécnico Nacional, Ciudad de México 11340, Mexico
dc.contributor.emailsperezt@ipn.mx (Sonia Mayra Pérez-Tapia) ; emilio.medina@udibi.com.mx(Emilio Medina-Rivero)
dc.creatorCarballo-Uicab, Gregorioes_ES
dc.creatorLinares-Trejo, José E.es_ES
dc.creatorMellado-Sánchez, Gabrielaes_ES
dc.creatorLópez-Morales, Carlos A.es_ES
dc.creatorVelasco-Velázquez, Marcoes_ES
dc.creatorPavón, Lenines_ES
dc.creatorEstrada-Parra, Sergioes_ES
dc.creatorPérez-Tapia, Sonia Mayraes_ES
dc.creatorMedina-Rivero, Emilioes_ES
dc.creator.identificadorhttps://orcid.org/0000-0002-9458-0776 (Carballo-Uicab, Gregorio)
dc.creator.identificadorhttps://orcid.org/0000-0001-7798-4907 (Linares-Trejo, José E.)
dc.creator.identificadorhttps://orcid.org/0000-0002-8299-5958 (Mellado-Sánchez, Gabriela)
dc.creator.identificadorhttps://orcid.org/0000-0001-8111-3127 (López-Morales, Carlos A.)
dc.creator.identificadorhttps://orcid.org/0000-0002-6067-6868 (Pavón, Lenin)
dc.creator.identificadorhttps://orcid.org/0000-0002-5752-592X (Estrada-Parra, Sergio)
dc.creator.identificadorhttps://orcid.org/0000-0002-2818-8522 (Pérez-Tapia, Sonia Mayra)
dc.creator.identificadorhttps://orcid.org/0000-0001-8862-1378 (Medina-Rivero, Emilio)
dc.date2019
dc.date.accessioned2022-11-28T19:38:38Z
dc.date.accessioned2026-03-27T15:25:28Z
dc.date.available2022-11-28T19:38:38Z
dc.date.issued2019
dc.date.published2019
dc.descriptionTransferon® is a blood product with immunomodulatory properties constituted by a complex mixture of peptides obtained from a human dialyzable leukocyte extract (DLE). Due to its complex nature, it is necessary to demonstrate batch consistency in its biological activity. Potency is the quantitative measure of biological activity and is also a quality attribute of drugs. Here we developed and validated a proliferation assay using Jurkat cells exposed to azathioprine, which is intended to determine the potency of Transferon® according to international guidelines for pharmaceuticals. The assay showed a linear response (2.5 to 40 µg/mL), coefficients of variation from 0.7 to 13.6% demonstrated that the method is precise, while r2 = 0.97 between the nominal and measured values obtained from dilutional linearity showed that the method is accurate. We also demonstrated that the cell proliferation response was specific for Transferon® and was not induced by its vehicle nor by other peptide complex mixtures (glatiramer acetate or hydrolyzed collagen). The bioassay validated here was used to assess the relative potency of eight released batches of Transferon® with respect to a reference standard, showing consistent results. The collective information from the validation and the assessment of several batches indicate that the bioassay is suitable for the release of Transferon®.es_ES
dc.formatPDFes_ES
dc.identifierJC20NC22es_ES
dc.identifier.doi10.3390/molecules24193426
dc.identifier.eissn1420-3049
dc.identifier.organizacionInstituto Nacional de Psiquiatría Ramón de la Fuente Muñiz
dc.identifier.placeSuiza
dc.identifier.urihttps://doi.org/10.3390/molecules24193426
dc.identifier.urihttps://repositorio.inprf.gob.mx/handle/123456789/7638
dc.language.isoenges_ES
dc.publisherMDPIes_ES
dc.relation24(19)3426
dc.relation.jnabreviadoMOLECULES
dc.relation.journalMolecules
dc.rightsAcceso Cerradoes_ES
dc.subject.kwDialyzable leukocyte extract
dc.subject.kwTransferon®
dc.subject.kwComplex mixture of peptides
dc.subject.kwQuality specifications
dc.subject.kwBiological potency
dc.subject.kwDevelopment and validation
dc.titleValidation of a cell proliferation assay to assess the potency of a dialyzable leukocyte extract intended for batch releasees_ES
dc.typeArtículoes_ES

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