Por la cual se expide la "Guía de Evaluación de la Inmunogenicidad para los Medicamentos Biológicos" y se dictan otras disposiciones.

Resolución · 4490 · 2016-09-27 · Jerarquía: nivel 8

Modificado
Normograma del Ministerio de Salud publica esta norma como «Parcialmente vigente» (consultado el 22/10/2026) .
Se sigue mostrando porque una norma derogada continúa rigiendo los hechos ocurridos mientras estuvo vigente: puede ser la norma aplicable a un caso de esa época.
La vigencia puede depender además de derogación tácita u orgánica, que ninguna base de datos refleja. Este dato es informativo y no constituye certificación; verifíquelo en la fuente oficial.
Articulado
Artículos 81–90 de 90

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El-Gewely, et al. (2012). "Antibodies against polyethylene glycol in healthy subjects and in patients treated with PEG-conjugated agents." Expert Opin Drug Deliv 9(11): 1319-1323. • Garces, S., J. Demengeot, et al. (2013). "The immunogenicity of anti-TNF therapy in immunemediated inflammatory diseases: a systematic review of the literature with a meta- analysis." Ann Rheum Dis 72(12): 1947-1955. • Ghaderi, D., R. E. Taylor, et al. (2010). "Implications of the presence of N-glycolylneuraminic acid in recombinant therapeutic glycoproteins." Nat Biotechnol 28(8): 863-867. • Gogas, H., J. loannovich, et al. (2006). "Prognostic significance of autoimmunity during treatment of melanoma with interferon." N Engl J Med 354(7): 709-718. • Gomord, V. and L. Faye (2004). "Posttranslational modification of therapeutic proteins in plants." Curr Opin Plant Biol 7(2): 171-181. • Gonzalez, M. L. and F. J. Waxman (2000). "Glomerular deposition of immune complexes made with IgG2a monoclonal antibodies." J Immunol 164(2): 1071-1077. • Goodnow, C. C. (1992). "Transgenic mice and analysis of B-cell tolerance." Annu Rey Immunol 10: 489-518. • Goronzy, J. J. and C. M. Weyand (2013). "Understanding immunosenescence to improve responses to vaccines." Nat Immunol 14(5): 428-436. RESOLUCIÓN NÚMERO 0 0 4 4 9 0 DE 16 HOJA No 37 de 39 77 SER 20?g Continuación de la resolución "Por la cual se expide la "Guía de Evaluación de la lnmunogenicidad para • Coto, S., H.

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Coto, et al. (2009). "Serum sickness with an elevated level of human anti- chimeric antibody following treatment with rituximab in a child with chronic immune thrombocytopenic purpura." Int J Hematol 89(3): 305-309. • Cross, P. C. and M. Zeppezauer (2010). "Infrared spectroscopy for biopharmaceutical protein analysis." J Pharm Biomed Anal 53(1): 29-36. • Hamilton, J. A. (2008). "Colony-stimulating factors in inflammation and autoimmunity." Nat Rey Immunol 8(7): 533-544. • Haribhai, D., D. Engle, et al. (2003). "A threshold for central T cell tolerance to an inducible serum protein." J Immunol 170(6): 3007-3014. • Harris, J. M., N. E. Martin, et al. (2001). "Pegylation a novel process for modifying pharmacokinetics." Clin Pharmacokinet 40(7): 539-551. • Hellmich, B., E. Csernok, et al. (2002). "Autoantibodies against granulocyte colony- stimulating factor in Felty's syndrome and neutropenic systemic lupus erythematosus." Arthritis Rheum 46(9): 2384-2391. • Hellwig, K., S. Schimrigk, et al. (2008). "Allergic and nonallergic delayed infusion reactions during natalizumab therapy." Arch Neurol 65(5): 656-658. • Hermeling, S., D. J. Crommelin, et al. (2004). "Structure-immunogenicity relationships of therapeutic proteins." Pharm Res 21(6): 897-903. • Hintermann, E., M. Holdener, et al. (2011). "Epitope spreading of the anti-CYP2D6 antibody response in patients with autoimmune hepatitis and in the CYP2D6 mouse model." J Autoimmun 37(3): 242-253. • Hoffmann, S., S.

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Cepok, et al. (2008). "HLA-DRB1*0401 and HLA-DRB1*0408 are strongly associated with the development of antibodies against interferon-beta therapy in multiple sclerosis." Am J Hum Genet 83(2): 219-227. • Hsu, D. H., J. D. Shi, et al. (1999). "A humanized anti-CD3 antibody, HuM291, with low mitogenic activity, mediates complete and reversible T-cell depletion in chimpanzees." Transplantation 68(4): 545-554. • Huang, L., J. Lu, et al. (2005). "In vivo deamidation characterization of monoclonal antibody by LC/MS/MS." Anal Chem 77(5): 1432-1439. • Hunley, T. E., D. Corzo, et al. (2004). "Nephrotic syndrome complicating alpha-glucosidase replacement therapy for Pompe disease." Pediatrics 114(4): e532-535. • Inada, Y., M. Furukawa, et al. (1995). "Biomedical and biotechnological applications of PEGand PM-modified proteins." Trends Biotechnol 13(3): 86-91. • lwasaki, A. and R. Medzhitov (2010). "Regulation of adaptive immunity by the innate immune system." Science 327(5963): 291-295. • Jefferis, R. and M. P. Lefranc (2009). "Human immunoglobulin allotypes: possible implications for immunogenicity." MAbs 1(4): 332-338. • Joubert, M. K., M. Hokom, et al. (2012). "Highly aggregated antibody therapeutics can enhance the in vitro innate and late-stage T-cell immune responses." J Biol Chem 287(30): 25266-25279. • Kessler, C. M. and T. L. Ortel (2009). "Recent developments in topical thrombins." Thromb Haemost 102(1): 15-24. • Kimchi-Sarfaty, C., T.

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Schiller, et al. (2013). "Building better drugs: developing and regulating engineered therapeutic proteins." Trends Pharmacol Sci 3400): 534-548. • Koren, E. (2002). "From characterization of antibodies to prediction of immunogenicity." Dev Biol (Basel) 109: 87-95. • Koren, E., H. W. Smith, et al. (2008). "Recommendations on risk-based strategies for detection and characterization of antibodies against biotechnology products." J Immunol Methods 3330-2): 1-9. • Kwissa, M., H. I. Nakaya, et al. (2012). "Distinct TLR adjuvants differentially stimulate systemic and local innate immune responses in nonhuman primates." Blood 119(9): 2044- 2055. • Lee, J. K. and P. Vadas (2011). "Anaphylaxis: mechanisms and management." Clin Exp Allergy 41(7): 923-938. • LeMaoult, J., P. Szabo, et al. (1997). "Effect of age on humoral immunity, selection of the B-cel repertoire and B-cell development." Immunol Rey 160: 115-126. RESOLUCIÓN NÚNIERCO 04490 DE 206 HOJA No 38 de 39 2 7 SEP 201 u Continuación de la resolución "Por la cual se expide la "Guía de Evaluación de la lnmunogenicidad para • Li, J., C. Yang, et al. (2001). "Thrombocytopenia caused by the development of antibodies to thrombopoietin." Blood 98(12): 3241-3248. • Liu, Y., H. Reidler, et al. (2011). "A double antigen bridging immunogenicity ELISA for the detection of antibodies to polyethylene glycol polymers." J Pharmacol Toxicol Methods 64(3): 238-245. • Macdougall, 1. C., S. D.

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Roger, et al. (2012). "Antibody-mediated pure red cell aplasia in chronic kidney disease patients receiving erythropoiesis-stimulating agents: new insights." Kidney Int 81(8): 727-732. • Mahler, H. C. and W. Jiskoot (2012). Analysis of Aggregates and Particles in Protein Pharmaceuticals. • Makrygiannakis, D., E. af Klint, et al. (2006). "Citrullination is an inflammation-dependent process." Ann Rheum Dis 65(9): 1219-1222. • Marszal, E. and E. Fowler (2012). "Workshop on predictive science of the immunogenicity aspects of particles in biopharmaceutical products." J Pharm Sci 101(10): 3555-3559. • Mendelsohn, N. J., Y. H. Messinger, et al. (2009). "Elimination of antibodies to recombinant enzyme in Pompe's disease." N Engl J Med 360(2): 194-195. • Messinger, Y. H., N. J. Mendelsohn, et al. (2012). "Successful immune tolerance induction to enzyme replacement therapy in CRIM-negative infantile Pompe disease." Genet Med 14(1): 135-142. • Miller, L. L., E. L. Korn, et al. (1999). "Abrogation of the hematological and biological activities of the interleukin-3/granulocyte-macrophage colony-stimulating factor fusion protein PIXY321 by neutralizing anti-PIXY321 antibodies in cancer patients receiving high- dose carboplatin." Blood 93(10): 3250-3258. • Mueller, R., A. Karle, et al. (2009). "Evaluation of the immuno-stimulatory potential of stopper extractables and leachables by using dendritic cells as readout." J Pharm Sci 98(10): 3548-3561. • Murphy, K. (2011). The Humoral Immune Response. Janeway's lmmunobiology. New York, Garland Science Publishing. 8th: 367-408. • Narhi, L. O., J.

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Schmit, et al. (2012). "Classification of protein aggregates." J Pharm Sci 101(2): 493-498. • Norman, D. J., F. Vincenti, et al. (2000). "Phase 1 trial of HuM291, a humanized anti-CD3 antibody, in patients receiving renal allografts from living donors." Transplantation 70(12): 1707-1712. • Pandey, G. S., C. Yanover, et al. (2013). "Polymorphisms in the F8 gene and MHC-Il variants as risk factors for the development of inhibitory anti-factor VIII antibodies during the treatment of hemophilia a: a computational assessment." PLoS Comput Biol 9(5): e1003066. • Pandey, G. S., C. Yanover, et al. (2013). "Endogenous factor VIII synthesis from the intron 22-inverted F8 locus may modulate the immunogenicity of replacement therapy for hemophilia A." Nat Med 19(10): 1318-1324. • PrabhuDas, M., B. Adkins, et al. (2011). "Challenges in infant immunity: implications for responses to infection and vaccines." Nat Immunol 12(3): 189-194. • Ragnhammar, P., H. J. Friesen, et al. (1994). "Induction of anti-recombinant human granulocytemacrophage colony-stimulating factor (Escherichia coli-derived) antibodies and clinical effects in nonimmunocompromised patients." Blood 84(12): 4078-4087. • Rhee, E. G., J. N. Blattman, etal. (2011). "Multiple innate immune pathways contribute to the immunogenicity of recombinant adenovirus vaccine vectors." J Virol 85(1): 315-323. • Roda, B., A. Zattoni, et al. (2009). "Field-flow fractionation in bioanalysis: A review of recent trends." Anal Chim Acta 635(2): 132-143. • Romer, P. S., S.

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Berr, et al. (2011). "Preculture of PBMCs at high cell density increases sensitivity of T-cell responses, revealing cytokine release by CD28 superagonist TGN1412." Blood 118(26): 6772-6782 • Rosenberg, A. S. and A. Worobec (2004). "A Risk-Based Approach to Immunogenicity Concerns of Therapeutic Protein Products, Pad 2: Considering Host-Specific and ProductSpecific Factors Impacting lmmunogenicity." BioPharm International. RESOLUCIÓN NÚMERO 0 0 4 4 9 0 DI 7 sEp 204116 HOJA No 39 de 39 • Rosenberg, A. S. and A. Worobec (2005). "A Risk-Based Approach to immunogenicity Concerns of Therapeutic Protein Products, Part 3: Effects of Manufacturing Changes in immunogenicity and the Utility of Animal Immunogenicity Studies." BioPharm International. • Sampson, H. A., A. Munoz-Furlong, et al. (2006). "Second symposium on the definition and management of anaphylaxis: summary report--Second National Institute of Allergy and infectious Disease/Food Allergy and Anaphylaxis Network symposium." J Allergy Clin immunol 117(2): 391-397. • Schellekens, H., W. E. Hennink, et al. (2013). "The immunogenicity of polyethylene glycol: facts and fichan." Pharm Res 30(7): 1729-1734. • Seidl, A., O. Hainzl, et al. (2012). "Tungsten-induced denaturation and aggregation of epoetin alfa during primary packaging as a cause of immunogenicity." Pharm Res 29(6): 1454-1467. • Seong, S. Y. and P. Matzinger (2004). "Hydrophobicity: an ancient damage-associated molecular pattern that initiates innate immune responses." Nat Rey Immunol 4(6): 469-478. • Shire, S. J., Z.

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Shahrokh, et al. (2004). "Challenges in the development of high protein concentration formulations." J Pharm Sci 93(6): 1390-1402. • Simons, F. E. (2010). "Anaphylaxis." J Allergy Clin immunol 125(2 Suppl 2): S161-181. • Singh, S. K. (2011). "Impact of product-related factors on immunogenicity of biotherapeutics." J Pharm Sci 100(2): 354-387. • Stanley, E., G. J. Lieschke, et al. (1994). "Granulocyte/macrophage colony-stimulating factordeficient mice show no major perturbation of hematopoiesis but develop a characteristic pulmonary pathology." Proc Nati Acad Sci U S A 91(12): 5592-5596. • Stebbings, R., D. Eastwood, et al. (2013). "After TGN1412: recent developments in cytokine release assays." J immunotoxicol 10(1): 75-82. • Stebbings, R., L. Findlay, et al. (2007). "Cytokine storm" in the phase I triar of monoclonal antibody TGN1412: better understanding the causes to improve preclinical testing of immunotherapeutics." J immunol 179(5): 3325-3331. • Tatarewicz, S. M., X. Wei, et al. (2007). "Development of a maturing T-cell-mediated immune response in patients with idiopathic Parkinson's disease receiving r-metHuGDNF via continuous intraputaminal infusion." J Clin Immunol 27(6): 620-627. • Tovey, M. G. and C. Lallemand (2010). Adjuvant Activity of Cytokines. Methods in Molecular Biology. G. Davies, Springer Science. • Verthelyi, D. and V. Wang (2010). "Trace levels of innate immune response modulating impurities (IIRMis) synergize to break tolerance to therapeutic proteins." PLoS One 50 2): e15252. • Viel, K. R., A.

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Tipo: Resolución

Estado: Modificado

Nivel jerárquico: 8

Fuente auxiliar: No

Fundamento: CP art. 189-11 y 208; Ley 489/1998 arts. 59 y 61; Sentencia C-1005/2008 (harness/ai/instructions/piramide-normativa.md).

Fuente de la vigencia: Vigencia según el Normograma del Ministerio de Salud (valor de la fuente: «Parcialmente vigente»; Normograma-tematicas-2016.zip · hoja RESOLUCIONES · fila 76), consultado el 2026-10-22. Texto extraído del PDF oficial por pdftotext; revisar contra el original antes de citar.

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