ArticlemAbs
Glycoengineered Pichia produced anti-HER2 is comparable to trastuzumab in preclinical study.
Article in mAbs. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 40 papers.
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Who cites it
40 citing papers in PubMed, 93 citations in OpenAlex.
- The landscape of antibody production systems: recombinant expression for research, diagnostics and therapy.Frontiers in bioengineering and biotechnology · 2026Review
- Adaptation of Aglycosylated Monoclonal Antibodies for Improved Production in Komagataella phaffii.Biotechnology and bioengineering · 2025Article
- Applications of the Methylotrophic YeastJournal of fungi (Basel, Switzerland) · 2024Review
- Impairment of IgG Fc functions promotes tumor progression and suppresses NK cell antitumor actions.Communications biology · 2022Article
- Strains and Molecular Tools for Recombinant Protein Production in Pichia pastoris.Methods in molecular biology (Clifton, N.J.) · 2022Article
- On the Use of Surface Plasmon Resonance Biosensing to Understand IgG-FcγR Interactions.International journal of molecular sciences · 2021Review
- Article
- Alternative hosts as the missing link for equitable therapeutic protein production.Nature biotechnology · 2021Article
- Applications, challenges, and needs for employing synthetic biology beyond the lab.Nature communications · 2021Review
- Engineering of Yeast Glycoprotein Expression.Advances in biochemical engineering/biotechnology · 2021Article
- Impact of IgG1 N-glycosylation on their interaction with Fc gamma receptors.Current research in immunology · 2020Article
- Host-Informed Expression of CRISPR Guide RNA for Genomic Engineering inACS synthetic biology · 2020Article
- Functional production of human antibody by the filamentous fungusFungal biology and biotechnology · 2020Article
- Evolving a Peptide: Library Platforms and Diversification Strategies.International journal of molecular sciences · 2019Review
- Glycoengineering of antibody (Herceptin) through yeast expression and in vitro enzymatic glycosylation.Proceedings of the National Academy of Sciences of the United States of America · 2018Article
- A streamlined cloning workflow minimising the time-to-strain pipeline for Pichia pastoris.Scientific reports · 2017Article
- Novel association of DJ-1 with HER3 potentiates HER3 activation and signaling in cancer.Oncotarget · 2016Article
- Synthetic biology and microbioreactor platforms for programmable production of biologics at the point-of-care.Nature communications · 2016Article
- Article
- Photochemical activation of MH3-B1/rGel: a HER2-targeted treatment approach for ovarian cancer.Oncotarget · 2015Article
Corrections and comments
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Authors and funding
19 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Mammalian cell culture systems are used predominantly for the production of therapeutic monoclonal antibody (mAb) products. A number of alternative platforms, such as Pichia engineered with a humanized N-linked glycosylation pathway, have recently been developed for the production of mAbs. The glycosylation profiles of mAbs produced in glycoengineered Pichia are similar to those of mAbs produced in mammalian systems. This report presents for the first time the comprehensive characterization of an anti-human epidermal growth factor receptor 2 (HER2) mAb produced in a glycoengineered Pichia, and a study comparing the anti-HER2 from Pichia, which had an amino acid sequence identical to trastuzumab, with trastuzumab. The comparative study covered a full spectrum of preclinical evaluation, including bioanalytical characterization, in vitro biological functions, in vivo anti-tumor efficacy and pharmacokinetics in both mice and non-human primates. Cell signaling and proliferation assays showed that anti-HER2 from Pichia had antagonist activities comparable to trastuzumab. However, Pichia-produced material showed a 5-fold increase in binding affinity to FcγIIIA and significantly enhanced antibody dependant cell-mediated cytotoxicity (ADCC) activity, presumably due to the lack of fucose on N-glycans. In a breast cancer xenograft mouse model, anti-HER2 was comparable to trastuzumab in tumor growth inhibition. Furthermore, comparable pharmacokinetic profiles were observed for anti-HER2 and trastuzumab in both mice and cynomolgus monkeys. We conclude that glycoengineered Pichia provides an alternative production platform for therapeutic mAbs and may be of particular interest for production of antibodies for which ADCC is part of the clinical mechanism of action.
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Registered trials
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