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珍しい中型ティラノサウルス類の骨?…北海道 (読売新聞)

北海道大学は20日、北海道芦別市の白亜紀後期(約1億年~約6600万年前)の地層から見つかった恐竜の化石が、ティラノサウルス類の尾の骨である可能性が高いことが分...

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Immunogenicity of glycans on biotherapeutic drugs produced in plant expression systems-The taliglucerase alfa story.

著者 Rup B , Alon S , Amit-Cohen BC , Brill Almon E , Chertkoff R , Tekoah Y , Rudd PM
PLoS One.2017 ; 12(10):e0186211.
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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.
PMID: 29088235 [PubMed - in process]
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