Dicroísmo circular y fluorescencia en la evaluación del material de referencia químico-físico y biológico del nimotuzumab
Palavras-chave:
nimotuzumab; material de referencia; dicroísmo circular; fluorescencia intrínseca.Resumo
El establecimiento de un material de referencia es necesario para los ensayos de control de
la calidad que se realizan a los medicamentos, garantizando mediciones confiables y
trazables. En el Centro de Inmunología Molecular se elaboró un nuevo candidato a material
de referencia para el Nimotuzumab con el objetivo de sustituir el vigente antes de su caducidad. En este trabajo se determinó la estructura secundaria y la estabilidad térmica de
los materiales, mediante dicroísmo circular en el ultravioleta lejano y el plegamiento
tridimensional mediante el ultravioleta cercano y fluorescencia intrínseca. Ambos
materiales presentaron predominio de hojas β (~ 42 %) y estabilidad termodinámica de
~ 71 oC. El plegamiento tridimensional mostró espectros muy similares en cuanto a la
posición de las bandas de absorción de los residuos aromáticos y la intensidad de emisión
de fluorescencia para la Tyr (336 nm) y para el Trp (337 nm).
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Molecular Enzymology. 1338 (2),161-185. [fecha de consulta 27 enero 2020]. Disponible
en:https://scholar.google.es/scholar?hl=es&as_sdt=0%2c5&q=
The+application+of+circula+dichroism+to+studies+of+protein+folding+and+unfolding+do
i&btnG=#d=gs_qabs&u=%23p%3DKKDHcCDzkAoJ
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del Centro de Inmunología Molecular. Siboney, Playa. 2020. H10 REST-0032/00
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Intranet del Centro de Inmunología Molecular. Siboney, Playa. 2020, H10 REST-0033/00
21. MORO-PÉREZ, L.; et al. “Conformational characterization of a novel anti-HER2
candidate antibody. PLoSOne”. 2019, 14 (5). https://doi.org/10.1371/journal.pone.0215442
22. VERMEER, A.W. y NORDE, W. “The termal stability of inmunoglobulin: unfolding
and aggregation of a multi-domain protein”. Biophysical Journal. 2019, 78.
https://doi.org/10.1016/s0006-3495(00)76602-1
23. KLIMTCHUK, E.S.; et al. “The critical role of the constant region in thermal stability
and aggregation of amyloidogenic immunoglobulin light chain”. Biochemistry. 2010,
49(45).
24. RAO, G.; et al. “Use of a folding model and in situ spectroscopic techniques for
rational formulation development and stability testing of monoclonal antibody
therapeutics”. J PharmSci. 2010, 99(4). https://doi.org/10.1002/jps.21938
25. LIU, J.; et al. “Assessing Analytical Similarity of Proposed Amgen Biosimilar ABP
501 to Adalimumab”. BioDrugs. 2016, 30(4). https://doi.org/10.1007/s40259-016-0184-3
Seminars in Oncology [en línea]. [fecha de consulta 27 enero 2020]. Disponible en:
https://pubmed.ncbi.nlm.nih.gov/30318080/
2. MATEO, C.; et al. “Humanization of a mouse monoclonal antibody that blocks the
epidermal growth factor receptor: recovery of antagonistic activity”. Immuno technology
1997, 3(1) https://doi.org/10.1016/s1380-2933(97)00065-1
3. MONOGIOUDI E.; et al. Committee for the Harmonisation of Autoimmune Testing
(C-HAT) of the International Federation of Clinical Chemistry and Laboratory Medicine
(IFCC). Certified reference material against PR3 ANCA Ig Gautoantibodies. From
development to certification. ClinChemLabMed. 2019, 57(8), 1197-1206.
doi: 10.1515/cclm-2018-1095.
4. SCHIEL, J. E. y TURNER, A. “The NISTmAb Reference Material 8671 lifecycle
management and quality plan”. Analytical and bioanalytical chemistry. 2018, 410(8),
https://doi.org/10.1007/s00216-017-0844-2
5. KIELBASA, A.; GADZAŁA-KOPCIUCH R. y BUSZEWSKI, B. “Reference Materials:
Significance, General Requirements, and Demand”. Critical Reviews in Analytical
Chemistry. 2016, 46 (3), https://doi.org/10.1080/10408347.2015.1045120
6. MONOGIOUDI E, ZEGERS I. “Certified Reference Materials and their need for the
diagnosis of autoimmunediseases”. Mediterr J Rheumatol. 2019, 30(1), 26-32.
doi: 10.31138/mjr.30.1.26. Disponible en: https://pubmed.ncbi.nlm.nih.gov/32185339/
7. CECMED Centro para el Control Estatal de los Medicamentos, Equipos y Dispositivos
Médicos Materiales de Referencia para medicamentos. Regulación No. 22 – 2012. La
Habana, Cuba. Ministerio de Salud Pública. 2012.
8. CIM Centro de Inmunología Molecular Programa para el establecimiento, cuidado y
conservación de los materiales de referencia. 2008. PG-25/ 01.
9. SCHIEL J.E.; et al. “The NISTmAb Reference Material 8671 value assignment,
homogeneity, and stability”. Analytical and Bioanalytical Chemistry. 2018, 410(8).
https://doi.org/10.1007/s00216-017-0800-1
10. Kestens V, Gerganova T, Roebben G, Held A. “A new certified reference material for
size and shape analysis of nanorods using electron microscopy”. Anal BioanalChem. 2021,
413(1), 141-157. doi: 10.1007/s00216-020-02984-z. Epub 2020 Oct 13.
11. GREENFIELD, N.J. “Using circular dichroism spectra to estimate protein secondary
structure”. Nature Protocols [en línea]. 2018, 1(6) [fecha de consulta 27 enero 2020].
Disponible en: https://www.nature.com/articles/nprot.2006.202
12. SAKAI-KATO K.; et al. Refining Calibration Procedures of Circular Dichroism
Spectrometer to Improve Usability. Anal Sci. 2019 35(11), 1275-1278.
doi: 10.2116/analsci.19N022.
13. WHITMORE L, WALLACE BA. DICHROWE B., An online server for protein
secondary structure analyses from circular dichroism spectroscopic data. Nucleic Acids
Res. 2004 Jul 1; 32(Web Server issue):W668-73. doi: 10.1093/nar/gkh371. PMID:
15215473; PMCID: PMC441509. fecha de consulta 27 enero 2020]. Disponible en:
https://academic.oup.com/nar/article/32/suppl_2/W668/1040470
14. PAUL, M.; VIEILLARD, V.; JACCOULET, E. y ASTIER, A. “Long-term stability of
diluted solutions of the monoclonal antibody rituximab. International”. Journal of
Pharmaceutics. 2012, 436 (1-2). https://doi.org/10.1016/j.ijpharm.2012.06.063
15. PAULI, J.; et al. “Influence of label and charge density on the association of the
therapeutic monoclonal antibodies trastuzumab and cetuximab conjugated to anionic
fluorophores”. ChemBioChem. 2017, 18 (1). https://doi.org/10.1002/cbic.201600299
16. MOORE-KELLY C.; et al. “Automated High- Throughput Capillary Circular
Dichroism and Intrinsic Fluorescence Spectroscopy for Rapid Determination of Protein
Structure”. Anal Chem. 2019, 91(21), 13794-13802. doi: 10.1021/acs.analchem.9b03259.
17. LEWIS R L, Seal EL, Lorts AR, Stewart AL. “Circular dichroism spectroscopy:
Enhancing a traditional undergraduate biochemistry laboratory experience”. Biochem Mol
BiolEduc. 2017, 45(6), 515-520. doi: 10.1002/bmb.21078.
18. KELLY, S. M. Y N. C. PRICE. The application of circular dichroism to studies of
protein folding and unfolding. Biochimica Et Biophisica Acta- Protein Structure and
Molecular Enzymology. 1338 (2),161-185. [fecha de consulta 27 enero 2020]. Disponible
en:https://scholar.google.es/scholar?hl=es&as_sdt=0%2c5&q=
The+application+of+circula+dichroism+to+studies+of+protein+folding+and+unfolding+do
i&btnG=#d=gs_qabs&u=%23p%3DKKDHcCDzkAoJ
19. CIM. Estabilidad del MRT (QFB) hR3/1605 almacenado a 4oC por 36 meses. Intranet
del Centro de Inmunología Molecular. Siboney, Playa. 2020. H10 REST-0032/00
20. CIM. Estabilidad del MRT (QFB) hR3/1605 almacenado a -70oC por 36 meses. .
Intranet del Centro de Inmunología Molecular. Siboney, Playa. 2020, H10 REST-0033/00
21. MORO-PÉREZ, L.; et al. “Conformational characterization of a novel anti-HER2
candidate antibody. PLoSOne”. 2019, 14 (5). https://doi.org/10.1371/journal.pone.0215442
22. VERMEER, A.W. y NORDE, W. “The termal stability of inmunoglobulin: unfolding
and aggregation of a multi-domain protein”. Biophysical Journal. 2019, 78.
https://doi.org/10.1016/s0006-3495(00)76602-1
23. KLIMTCHUK, E.S.; et al. “The critical role of the constant region in thermal stability
and aggregation of amyloidogenic immunoglobulin light chain”. Biochemistry. 2010,
49(45).
24. RAO, G.; et al. “Use of a folding model and in situ spectroscopic techniques for
rational formulation development and stability testing of monoclonal antibody
therapeutics”. J PharmSci. 2010, 99(4). https://doi.org/10.1002/jps.21938
25. LIU, J.; et al. “Assessing Analytical Similarity of Proposed Amgen Biosimilar ABP
501 to Adalimumab”. BioDrugs. 2016, 30(4). https://doi.org/10.1007/s40259-016-0184-3
Publicado
2021-03-10
Como Citar
Porras-Vega, S., Váldez-Núñez, R., Gómez-Pérez, J. A., Ruiz-Ramirez, I., & Romero-Batista, Y. de la R. (2021). Dicroísmo circular y fluorescencia en la evaluación del material de referencia químico-físico y biológico del nimotuzumab. Revista Cubana De Química, 33(1), 3–21. Recuperado de https://cubanaquimica.uo.edu.cu/index.php/cq/article/view/5164
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