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Immunogenicity of glycans on biotherapeutic drugs produced in plant expression systems-The taliglucerase alfa story.
Rup, Bonita; Alon, Sari; Amit-Cohen, Bat-Chen; Brill Almon, Einat; Chertkoff, Raul; Tekoah, Yoram; Rudd, Pauline M.
Afiliação
  • Rup B; Bonnie Rup Consulting, LLC, Reading, Massachusetts, United States of America.
  • Alon S; Product Development, Protalix LTD, Carmiel, Israel.
  • Amit-Cohen BC; Product Development, Protalix LTD, Carmiel, Israel.
  • Brill Almon E; Product Development, Protalix LTD, Carmiel, Israel.
  • Chertkoff R; Product Development, Protalix LTD, Carmiel, Israel.
  • Tekoah Y; Research and Development, Protalix LTD, Carmiel, Israel.
  • Rudd PM; National Institute for Bioprocessing Research and Training, Dublin, Ireland.
PLoS One ; 12(10): e0186211, 2017.
Article em En | MEDLINE | ID: mdl-29088235
ABSTRACT
Plants are a promising alternative for the production of biotherapeutics. Manufacturing in-planta adds plant specific glycans. To understand immunogenic potential of these glycans, we developed a validated method to detect plant specific glycan antibodies in human serum. Using this assay, low prevalence of pre-existing anti-plant glycan antibodies was found in healthy humans (13.5%) and in glucocerebrosidase-deficient Gaucher disease (GD) patients (5%). A low incidence (9% in naïve patient and none in treatment experienced patients) of induced anti-plant glycan antibodies was observed in GD patients after up to 30 months replacement therapy treatment with taliglucerase alfa, a version of human glucocerebrosidase produced in plant cells. Detailed evaluation of clinical safety and efficacy endpoints indicated that anti-plant glycan antibodies did not affect the safety or efficacy of taliglucerase alfa in patients. This study shows the benefit of using large scale human trials to evaluate the immunogenicity risk of plant derived glycans, and indicates no apparent risk related to anti-plant glycan antibodies.
Assuntos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Plantas / Polissacarídeos / Produtos Biológicos / Glucosilceramidase Tipo de estudo: Clinical_trials / Risk_factors_studies Limite: Female / Humans / Male Idioma: En Revista: PLoS One Assunto da revista: CIENCIA / MEDICINA Ano de publicação: 2017 Tipo de documento: Article País de afiliação: Estados Unidos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Plantas / Polissacarídeos / Produtos Biológicos / Glucosilceramidase Tipo de estudo: Clinical_trials / Risk_factors_studies Limite: Female / Humans / Male Idioma: En Revista: PLoS One Assunto da revista: CIENCIA / MEDICINA Ano de publicação: 2017 Tipo de documento: Article País de afiliação: Estados Unidos