Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
7631056 | Journal of Pharmaceutical and Biomedical Analysis | 2014 | 6 Pages |
Abstract
- We developed and validated an SE-UPLC method to assess identity of Transferonâ¢.
- Ten representative batches complied with physicochemical quality attributes.
- All batches consistently induced IFN-γ production in cultures of Jurkat cells.
- Transferon⢠is produced with high homogeneity between batches.
Keywords
DLEIFN-γGMPsDTHNF-κBUPLCFDABCAIL-6RSDIFN-gammacAMPCyclic adenosine monophosphaterelative standard deviationstandard deviationinterleukin 6SERdelayed-type hypersensitivitytumor necrosis factor alphaDaltonsGood Manufacturing PracticesFood and Drug AdministrationSerineReverse-phaseTNF-αnuclear factor kappa BSize exclusionQuality specificationsICHUltra-performance liquid chromatographyhigh-performance liquid chromatographyHPLCInternational Conference of HarmonizationInterferon gammaGluglutamineGlyGlycine
Related Topics
Physical Sciences and Engineering
Chemistry
Analytical Chemistry
Authors
Emilio Medina-Rivero, Giovanna Merchand-Reyes, Lenin Pavón, Said Vázquez-Leyva, Gilberto Pérez-Sánchez, Nohemà Salinas-JazmÃn, Sergio Estrada-Parra, Marco Velasco-Velázquez, Sonia Mayra Pérez-Tapia,