Structural meta-analysis of regular human insulin in pharmaceutical formulations

Detalhes bibliográficos
Autor(a) principal: Fávero-Retto, Maely P.
Data de Publicação: 2013
Outros Autores: Palmieri, Leonardo C., Souza, Tatiana de Arruda Campos Brasil de, Almeida, Fabio C. L., Lima, Luís Mauricio T.R.
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/16022
Resumo: Instituto Nacional de Traumato-Ortopedia (INTO-MS-Brasil), Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES); Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq), INCT-CNPq; Fundação de Amparo à Pesquisa do Estado do Rio de Janeiro Carlos Chagas Filho (FAPERJ), Brazillian Synchrotron Light Laboratory (LNLS) and Instituto Nacional de Metrologia, Normalização e Qualidade Industrial (INMETRO)
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spelling Fávero-Retto, Maely P.Palmieri, Leonardo C.Souza, Tatiana de Arruda Campos Brasil deAlmeida, Fabio C. L.Lima, Luís Mauricio T.R.2016-09-30T18:45:20Z2016-09-30T18:45:20Z2013FÁVERO-RETTO, Maely P. et al. Structural meta-analysis of regular human insulin in pharmaceutical formulations. Eur. J. Pharm. Biopharm, v.85, n.3, Pt. B, p. 1112-1121, 2013.0939-6411https://www.arca.fiocruz.br/handle/icict/1602210.1016/j.ejpb.2013.05.005Instituto Nacional de Traumato-Ortopedia (INTO-MS-Brasil), Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES); Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq), INCT-CNPq; Fundação de Amparo à Pesquisa do Estado do Rio de Janeiro Carlos Chagas Filho (FAPERJ), Brazillian Synchrotron Light Laboratory (LNLS) and Instituto Nacional de Metrologia, Normalização e Qualidade Industrial (INMETRO)Universidade Federal do Rio de Janeiro. Faculdade de Farmácia. Rio de Janeiro, RJ, Brasil. / Instituto Nacional de Câncer. Rio de Janeiro, RJ, Brasil. / Instituto Nacional de Traumatologia e Ortopedia. Rio de Janeiro, RJ, Brasil.Universidade Federal do Rio de Janeiro. Faculdade de Farmácia. Rio de Janeiro, RJ, Brasil.Centro Nacional de Pesquisa em Energia e Materiais. Laboratório Nacional de Luz Síncrotron. Campinas, SP, Brasil. / Fundação Oswaldo Cruz. Instituto Carlos Chagas. Curitiba, PR, Brasil.Universidade Federal do Rio de Janeiro. Instituto de Bioquímica Médica. Centro Nacional de Ressonância Magnética Nuclear. Rio de Janeiro, RJ, Brasil. / Universidade Federal do Rio de Janeiro. Instituto Nacional de Ciência e Tecnologia para Biologia Estrutural e Bioimagem. Rio de Janeiro, RJ, Brasil.Universidade Federal do Rio de Janeiro. Faculdade de Farmácia. Rio de Janeiro, RJ, Brasil. / Universidade Federal do Rio de Janeiro. Instituto Nacional de Ciência e Tecnologia para Biologia Estrutural e Bioimagem. Rio de Janeiro, RJ, Brasil. / Instituto Nacional de Metrologia, Qualidade e Tecnologia. Laboratório de Biologia Estrutural. Rio de Janeiro, RJ, Brasil.We have studied regular acting, wild-type human insulin at potency of 100 U/mL from four different pharmaceutical products directly from their final finished formulation by the combined use of mass spectrometry (MS), dynamic light scattering (DLS), small-angle X-ray scattering (SAXS), nuclear magnetic resonance (NMR), and single-crystal protein crystallography (PX). All products showed similar oligomeric assembly in solution as judged by DLS and SAXS measurements. The NMR spectra were compatible with well folded proteins, showing close conformational identity for the human insulin in the four products. Crystallographic assays conducted with the final formulated products resulted in all insulin crystals belonging to the R3 space group with two a dimer in the asymmetric unit, both with the B-chain in the T configuration. Meta-analysis of the 24 crystal structures solved from the four distinct insulin products revealed close similarity between them regardless of variables such as biological origin, product batch, country origin of the product, and analytical approach, revealing a low conformational variability for the converging insulin structural ensemble. We propose the use of MS, SAXS, NMR fingerprint, and PX as a precise chemical and structural proof of folding identity of regular insulin in the final, formulated product.engA. GoepferichStructural meta-analysis of regular human insulin in pharmaceutical formulationsinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleHuman insulinCrystallographyNuclear magnetic resonanceMass spectraSmall-angle X-ray scatteringBiosimilarMeta-analysisInsulina Isófana HumanaCristalografiaEspectroscopia de Ressonância MagnéticaMedicamentos BiossimilaresMetanáliseinfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-83074https://www.arca.fiocruz.br/bitstream/icict/16022/1/license.txt0271fb68963c017aa933c7aff60379f4MD51ORIGINALStructural meta-analysis of regular human insulin in pharmaceutical formulations.pdfStructural meta-analysis of regular human insulin in pharmaceutical 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dc.title.pt_BR.fl_str_mv Structural meta-analysis of regular human insulin in pharmaceutical formulations
title Structural meta-analysis of regular human insulin in pharmaceutical formulations
spellingShingle Structural meta-analysis of regular human insulin in pharmaceutical formulations
Fávero-Retto, Maely P.
Human insulin
Crystallography
Nuclear magnetic resonance
Mass spectra
Small-angle X-ray scattering
Biosimilar
Meta-analysis
Insulina Isófana Humana
Cristalografia
Espectroscopia de Ressonância Magnética
Medicamentos Biossimilares
Metanálise
title_short Structural meta-analysis of regular human insulin in pharmaceutical formulations
title_full Structural meta-analysis of regular human insulin in pharmaceutical formulations
title_fullStr Structural meta-analysis of regular human insulin in pharmaceutical formulations
title_full_unstemmed Structural meta-analysis of regular human insulin in pharmaceutical formulations
title_sort Structural meta-analysis of regular human insulin in pharmaceutical formulations
author Fávero-Retto, Maely P.
author_facet Fávero-Retto, Maely P.
Palmieri, Leonardo C.
Souza, Tatiana de Arruda Campos Brasil de
Almeida, Fabio C. L.
Lima, Luís Mauricio T.R.
author_role author
author2 Palmieri, Leonardo C.
Souza, Tatiana de Arruda Campos Brasil de
Almeida, Fabio C. L.
Lima, Luís Mauricio T.R.
author2_role author
author
author
author
dc.contributor.author.fl_str_mv Fávero-Retto, Maely P.
Palmieri, Leonardo C.
Souza, Tatiana de Arruda Campos Brasil de
Almeida, Fabio C. L.
Lima, Luís Mauricio T.R.
dc.subject.en.pt_BR.fl_str_mv Human insulin
Crystallography
Nuclear magnetic resonance
Mass spectra
Small-angle X-ray scattering
Biosimilar
Meta-analysis
topic Human insulin
Crystallography
Nuclear magnetic resonance
Mass spectra
Small-angle X-ray scattering
Biosimilar
Meta-analysis
Insulina Isófana Humana
Cristalografia
Espectroscopia de Ressonância Magnética
Medicamentos Biossimilares
Metanálise
dc.subject.decs.pt_BR.fl_str_mv Insulina Isófana Humana
Cristalografia
Espectroscopia de Ressonância Magnética
Medicamentos Biossimilares
Metanálise
description Instituto Nacional de Traumato-Ortopedia (INTO-MS-Brasil), Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES); Conselho Nacional de Desenvolvimento Científico e Tecnológico (CNPq), INCT-CNPq; Fundação de Amparo à Pesquisa do Estado do Rio de Janeiro Carlos Chagas Filho (FAPERJ), Brazillian Synchrotron Light Laboratory (LNLS) and Instituto Nacional de Metrologia, Normalização e Qualidade Industrial (INMETRO)
publishDate 2013
dc.date.issued.fl_str_mv 2013
dc.date.accessioned.fl_str_mv 2016-09-30T18:45:20Z
dc.date.available.fl_str_mv 2016-09-30T18:45:20Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.citation.fl_str_mv FÁVERO-RETTO, Maely P. et al. Structural meta-analysis of regular human insulin in pharmaceutical formulations. Eur. J. Pharm. Biopharm, v.85, n.3, Pt. B, p. 1112-1121, 2013.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/16022
dc.identifier.issn.pt_BR.fl_str_mv 0939-6411
dc.identifier.doi.pt_BR.fl_str_mv 10.1016/j.ejpb.2013.05.005
identifier_str_mv FÁVERO-RETTO, Maely P. et al. Structural meta-analysis of regular human insulin in pharmaceutical formulations. Eur. J. Pharm. Biopharm, v.85, n.3, Pt. B, p. 1112-1121, 2013.
0939-6411
10.1016/j.ejpb.2013.05.005
url https://www.arca.fiocruz.br/handle/icict/16022
dc.language.iso.fl_str_mv eng
language eng
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv A. Goepferich
publisher.none.fl_str_mv A. Goepferich
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
instname_str Fundação Oswaldo Cruz (FIOCRUZ)
instacron_str FIOCRUZ
institution FIOCRUZ
reponame_str Repositório Institucional da FIOCRUZ (ARCA)
collection Repositório Institucional da FIOCRUZ (ARCA)
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