Noritaka Hashii
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View article: Usefulness of Size-Exclusion Chromatography–Multi-Angle Light Scattering to Assess Particle Composition and Protein Impurities for Quality Control of Therapeutic Exosome Preparations
Usefulness of Size-Exclusion Chromatography–Multi-Angle Light Scattering to Assess Particle Composition and Protein Impurities for Quality Control of Therapeutic Exosome Preparations Open
Background: Extracellular vesicles (EVs), including exosomes, are promising pharmaceutical modalities. They are purified from cell culture supernatant; however, the preparation may contain EVs with the desired therapeutic effects and diffe…
View article: Involvement of Metalloproteases in the Fertilization of the Ascidian Halocynthia roretzi
Involvement of Metalloproteases in the Fertilization of the Ascidian Halocynthia roretzi Open
We previously reported that five astacin-like metalloproteases with thrombospondin type-1 repeats (Tasts) located on the sperm surface are a promising candidate as the protease involved in sperm penetration of the vitelline coat (VC) durin…
View article: Multi-attribute method analysis of therapeutic monoclonal antibodies using an automated sample preparation system
Multi-attribute method analysis of therapeutic monoclonal antibodies using an automated sample preparation system Open
The multi-attribute method (MAM) has attracted increased attention as an alternative strategy for evaluating structural heterogeneity using conventional separation techniques such as ion-exchange chromatography and capillary electrophoresi…
View article: Designing strong inducible synthetic promoters in yeasts
Designing strong inducible synthetic promoters in yeasts Open
Inducible promoters are essential for precise control of target gene expression in synthetic biological systems. However, engineering eukaryotic promoters is often more challenging than engineering prokaryotic promoters due to their greate…
View article: Pathogenicity of IgG-Fc desialylation and its association with Th17 cells in an animal model of systemic lupus erythematosus
Pathogenicity of IgG-Fc desialylation and its association with Th17 cells in an animal model of systemic lupus erythematosus Open
Objectives Decreased sialylation of IgG-Fc glycans has been reported in autoimmune diseases, but its role in systemic lupus erythematosus (SLE) is not fully understood. In this study, we examined the pathogenicity of IgG desialylation and …
View article: Antibody feedback contributes to facilitating the development of Omicron-reactive memory B cells in SARS-CoV-2 mRNA vaccinees
Antibody feedback contributes to facilitating the development of Omicron-reactive memory B cells in SARS-CoV-2 mRNA vaccinees Open
In contrast to a second dose of the SARS-CoV-2 mRNA vaccine, a third dose elicits potent neutralizing activity against the Omicron variant. To address the underlying mechanism for this differential antibody response, we examined spike rece…
View article: Quality Evaluation of Therapeutic Antibodies by Multi-attribute Method
Quality Evaluation of Therapeutic Antibodies by Multi-attribute Method Open
In the development of therapeutic monoclonal antibodies (mAbs), it is essential to characterize the modifications causing structural heterogeneity because certain modifications are associated with safety and efficacy. However, the rapid st…
View article: Evaluation of structural properties of therapeutic antibodies by multi-attribute method
Evaluation of structural properties of therapeutic antibodies by multi-attribute method Open
抗体医薬品は、細胞培養、精製、製剤化などの製造工程、および保存条件下でさまざまな修飾を受けることが知られている。抗体医薬品の品質確保のためには、その変動が有効性・安全性に影響を及ぼす可能性のある構造特性が、あらかじめ規定した限度・範囲・分布内となる管理戦略を構築することが重要である。抗体医薬品のクロマトグラフィー技術を中心とした構造評価手法は確立されている一方で、複数種類の分析を実施する必要があり、その煩雑さから評価手法の集約と簡略化が議論されている。このような背景の下、m…
View article: Purified EDEM3 or EDEM1 alone produces determinant oligosaccharide structures from M8B in mammalian glycoprotein ERAD
Purified EDEM3 or EDEM1 alone produces determinant oligosaccharide structures from M8B in mammalian glycoprotein ERAD Open
Sequential mannose trimming of N -glycan, from M9 to M8B and then to oligosaccharides exposing the α1,6-linked mannosyl residue (M7A, M6, and M5), facilitates endoplasmic reticulum-associated degradation of misfolded glycoproteins (gpERAD)…
View article: Glycan engineering of the SARS-CoV-2 receptor-binding domain elicits cross-neutralizing antibodies for SARS-related viruses
Glycan engineering of the SARS-CoV-2 receptor-binding domain elicits cross-neutralizing antibodies for SARS-related viruses Open
Broadly protective vaccines against SARS-related coronaviruses that may cause future outbreaks are urgently needed. The SARS-CoV-2 spike receptor-binding domain (RBD) comprises two regions, the core-RBD and the receptor-binding motif (RBM)…
View article: Author response: Purified EDEM3 or EDEM1 alone produces determinant oligosaccharide structures from M8B in mammalian glycoprotein ERAD
Author response: Purified EDEM3 or EDEM1 alone produces determinant oligosaccharide structures from M8B in mammalian glycoprotein ERAD Open
Article Figures and data Abstract Editor's evaluation Introduction Results Discussion Materials and methods Data availability References Decision letter Author response Article and author information Metrics Abstract Sequential mannose tri…
View article: The influence of antibody engineering on Fc conformation and Fc receptor binding properties: Analysis of FcRn-binding engineered antibodies and an Fc fusion protein
The influence of antibody engineering on Fc conformation and Fc receptor binding properties: Analysis of FcRn-binding engineered antibodies and an Fc fusion protein Open
Therapeutic immunoglobulin G (IgG) antibodies have comparatively long half-lives because the neonatal Fc receptor (FcRn) binds to the IgG Fc at acidic pH in the endosome and protects IgG from degradation. To further prolong the half-lives,…
View article: Generic MS-Based Method for The Bioanalysis of Therapeutic Monoclonal Antibodies in Nonclinical Studies
Generic MS-Based Method for The Bioanalysis of Therapeutic Monoclonal Antibodies in Nonclinical Studies Open
Aim: A generic bioanalytical method was developed to quantify therapeutic IgG1 monoclonal antibodies (mAbs) in mouse sera by combining an easy sample preparation method with LC/MS using selected reaction monitoring. Materials & methods: Ri…
View article: Establishment of a highly precise multi-attribute method for the characterization and quality control of therapeutic monoclonal antibodies
Establishment of a highly precise multi-attribute method for the characterization and quality control of therapeutic monoclonal antibodies Open
The multi-attribute method (MAM) has garnered attention as a new quality control method of therapeutic monoclonal antibodies (mAbs). MAM analysis allows multiple relative quantifications of several structural attributes of therapeutic mAbs…
View article: Effects of terminal galactose residues in mannose α1-6 arm of Fc-glycan on the effector functions of therapeutic monoclonal antibodies
Effects of terminal galactose residues in mannose α1-6 arm of Fc-glycan on the effector functions of therapeutic monoclonal antibodies Open
Typical crystallizable fragment (Fc) glycans attached to the CH2 domain in therapeutic monoclonal antibodies (mAbs) are core-fucosylated and asialo-biantennary complex-type glycans, e.g., G2F (full galactosylation), G1aF (terminal galactos…
View article: Site-specific <i>O</i>-Glycosylation Analysis of Therapeutic Fc-fusion Protein by Mass Spectrometry
Site-specific <i>O</i>-Glycosylation Analysis of Therapeutic Fc-fusion Protein by Mass Spectrometry Open
Therapeutic Fc-fusion proteins, created by linking bioactive peptides or receptor proteins to the Fc moiety of IgG, are currently being developed. In this development process, a Gly-Gly-Gly-Ser linker (G4S linker) is often used to link the…
View article: Quality characterization of biological products by mass spectrometry
Quality characterization of biological products by mass spectrometry Open
質量分析法は，バイオ医薬品の構造・組成や物理的化学的性質にかかわる様々な品質特性を明らかにするために汎用されている分析手法の一つである．例えば，液体クロマトグラフィー／質量分析（LC/MS）によるペプチドマッピングは，一次構造やジスルフィド結合等のタンパク質の基本骨格の解析に加えて，糖鎖付加，酸化，及び脱アミド化などの翻訳後修飾解析のためにも不可欠となっている．さらには，水素重水素交換反応とLC/MSによるペプチドマッピングを組み合わせた手法（HDX/MS法）が高次構造の評…
View article: Bioanalytical Quantification of Therapeutic Antibodies by Liquid Chromatography/mass Spectrometry
Bioanalytical Quantification of Therapeutic Antibodies by Liquid Chromatography/mass Spectrometry Open
Liquid chromatography/mass spectrometry (LC/MS) method is becoming an important approach for therapeutic antibody assays as an alternative to the ligand-binding assay (LBA) method. The LC/MS method has some advantages over the LBA method, …