Evidence map›Paper›PMID 29088235›Full record

Trial reportPloS one2017

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

Bonita Rup, Sari Alon, Bat-Chen Amit-Cohen, Einat Brill Almon, Raul Chertkoff, Yoram Tekoah, Pauline M Rudd

Open access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in PloS one, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers.

0numbers the graph read from it
0cells of the map it votes in
33citing papers in PubMed
4.0field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

33 citing papers in PubMed, 52 citations in OpenAlex.

  1. Plant-Based Systems for Producing Therapeutic Proteins: Current Status and Future Prospects.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2026
    Review
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  9. Review
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  11. Green Biologics: Harnessing the Power of Plants to Produce Pharmaceuticals.International journal of molecular sciences · 2023
    Review
  12. Article
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  15. Article
  16. Product safety aspects of plant molecular farming.Frontiers in bioengineering and biotechnology · 2023
    Review
  17. Article
  18. Article
  19. Review
  20. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors at 2 institutions in 3 countries.

Bonita RupBonnie Rup Consulting, LLC, Reading, Massachusetts, United States of America.
Sari AlonProduct Development, Protalix LTD, Carmiel, Israel.
Bat-Chen Amit-CohenProduct Development, Protalix LTD, Carmiel, Israel.
Einat Brill AlmonProduct Development, Protalix LTD, Carmiel, Israel.
Raul ChertkoffProduct Development, Protalix LTD, Carmiel, Israel.
Yoram TekoahResearch and Development, Protalix LTD, Carmiel, Israel.ORCID http://orcid.org/0000-0002-6134-059X
Pauline M RuddNational Institute for Bioprocessing Research and Training, Dublin, Ireland.
Protalix BioTherapeutics (Israel) · ILBioprocessing Technology Institute · SG

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Biological ProductsDouble-Blind MethodEnzyme-Linked Immunosorbent AssayFemaleGaucher DiseaseGlucosylceramidaseGlycosylationHumansMalePlantsPolysaccharidesBiological ProductsGlucosylceramidasePolysaccharidestaliglucerase alfa

Identifiers

PMID29088235
PMCPMC5663370
OpenAlexW2766457869

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.