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  1. Article: [Omics and cell controlling technology for drug discovery].

    Fukuda, Masakazu / Danno, Hiroki

    Nihon yakurigaku zasshi. Folia pharmacologica Japonica

    2023  Volume 159, Issue 1, Page(s) 48–52

    Abstract: Knowledge Palette, Inc. is a start-up company that aims to overcome incurable diseases by applying the world's most accurate single-cell level and bulk level transcriptome technology to obtain large-scale data on the state of cells treated with various ... ...

    Abstract Knowledge Palette, Inc. is a start-up company that aims to overcome incurable diseases by applying the world's most accurate single-cell level and bulk level transcriptome technology to obtain large-scale data on the state of cells treated with various types of drugs and media, and using this information to highly control cells for improving human health. We are working on new phenotypic drug discovery and higher quality cells for regenerative medicine using big data. As one of its core technologies, the company is utilizing a single-cell-level whole gene expression analysis technology, Quartz-Seq2, which was originally developed in RIKEN. This technology received first place in accuracy of genes detection as well as marker identification, and was ranked No. 1 in overall score in the benchmarking in the international Human Cell Atlas project. By applying this technology to the bulk level analysis of ultra-multiple samples, it has enabled drug screening, analysis of human clinical specimens, and evaluation of numerous culture environments in a high-throughput way. This paper presents an omics-driven drug discovery and cell regulation approach that is combined with large-scale data and artificial intelligence technology.
    MeSH term(s) Humans ; Artificial Intelligence ; Technology ; Drug Discovery ; Transcriptome
    Language Japanese
    Publishing date 2023-12-14
    Publishing country Japan
    Document type English Abstract ; Journal Article
    ZDB-ID 1097532-9
    ISSN 1347-8397 ; 0015-5691
    ISSN (online) 1347-8397
    ISSN 0015-5691
    DOI 10.1254/fpj.23098
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  2. Article ; Online: Correction: Quantitative Correlation between Viscosity of Concentrated MAb Solutions and Particle Size Parameters Obtained from Small-Angle X-ray Scattering.

    Fukuda, Masakazu / Moriyama, Chifumi / Yamazaki, Tadao / Imaeda, Yoshimi / Koga, Akiko

    Pharmaceutical research

    2023  Volume 40, Issue 3, Page(s) 791

    Language English
    Publishing date 2023-01-29
    Publishing country United States
    Document type Published Erratum
    ZDB-ID 843063-9
    ISSN 1573-904X ; 0724-8741 ; 0739-0742
    ISSN (online) 1573-904X
    ISSN 0724-8741 ; 0739-0742
    DOI 10.1007/s11095-023-03479-z
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  3. Article ; Online: Remimazolam for a patient with myotonic dystrophy type 1 who underwent endoscopic retrograde cholangiopancreatography under general anesthesia: a case report.

    Fukuda, Masakazu / Tachibana, Shunsuke / Nishihara, Noriaki / Yamakage, Michiaki

    JA clinical reports

    2021  Volume 7, Issue 1, Page(s) 17

    Abstract: Background: Remimazolam is a benzodiazepine receptor agonist with an ultra-short-acting anesthetic effect. We used remimazolam for anesthesia in a patient with myotonic dystrophy type 1 who underwent endoscopic retrograde cholangiopancreatography (ERCP). ...

    Abstract Background: Remimazolam is a benzodiazepine receptor agonist with an ultra-short-acting anesthetic effect. We used remimazolam for anesthesia in a patient with myotonic dystrophy type 1 who underwent endoscopic retrograde cholangiopancreatography (ERCP).
    Case presentation: A 58-year-old woman received ERCP under general anesthesia. She had impaired respiratory function due to myotonic dystrophy type I and was at a risk of respiratory complications after anesthesia. General anesthesia was induced with remimazolam 12 mg/kg/h, remifentanil 0.1 μg/kg/min and rocuronium 15 mg, followed by tracheal intubation and maintained with remimazolam 0.8-1.0 mg/kg/h. At the end of anesthesia, we injected sugammadex 150 mg and flumazenil 0.2 mg, allowing smooth and clear emergence from anesthesia. She was discharged from the hospital without any respiratory problems on postoperative day 5.
    Conclusions: Remimazolam was safe to use for general anesthesia in a patient with myotonic dystrophy type 1 undergoing ERCP.
    Language English
    Publishing date 2021-02-24
    Publishing country Germany
    Document type Journal Article
    ISSN 2363-9024
    ISSN (online) 2363-9024
    DOI 10.1186/s40981-021-00422-2
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  4. Article ; Online: Viscosity increase/gelation of therapeutic IgG monoclonal antibodies induced by Zn

    Fukuda, Masakazu / Yamazaki, Tadao / Ueno, Seiji / Koga, Akiko / Yamanaka, Yuji

    European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V

    2022  Volume 178, Page(s) 179–186

    Abstract: We investigated the elution of zinc ions ( ... ...

    Abstract We investigated the elution of zinc ions (Zn
    MeSH term(s) Antibodies, Monoclonal/chemistry ; Elastomers ; Immunoglobulin G/chemistry ; Scattering, Small Angle ; Syringes ; Viscosity ; X-Ray Diffraction ; Zinc
    Chemical Substances Antibodies, Monoclonal ; Elastomers ; Immunoglobulin G ; Zinc (J41CSQ7QDS)
    Language English
    Publishing date 2022-08-25
    Publishing country Netherlands
    Document type Journal Article
    ZDB-ID 1065368-5
    ISSN 1873-3441 ; 0939-6411
    ISSN (online) 1873-3441
    ISSN 0939-6411
    DOI 10.1016/j.ejpb.2022.08.008
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  5. Article ; Online: Small conformational changes in IgG1 detected as acidic charge variants by cation exchange chromatography

    Fukuda, Masakazu / Graewert, Melissa A. / Jeffries, Cy M. / Svergun, Dmitri I. / Yamazaki, Tadao / Koga, Akiko / Yamanaka, Yuji

    Analytical Biochemistry. 2023 Nov., v. 680 p.115302-

    2023  

    Abstract: Fully characterizing the post-translational modifications present in charge variants of therapeutic monoclonal antibodies (mAbs), particularly acidic variants, is challenging and remains an open area of investigation. In this study, to test the ... ...

    Abstract Fully characterizing the post-translational modifications present in charge variants of therapeutic monoclonal antibodies (mAbs), particularly acidic variants, is challenging and remains an open area of investigation. In this study, to test the possibility that chromatographically separated acidic fractions of therapeutic mAbs contain conformational variants, we undertook a mAb refolding approach using as a case study an IgG1 that contains many unidentified acidic peaks with few post-translational modifications, and examined whether different acidic peak fractions could be generated corresponding to these variants. The IgG1 drug substance was denatured by guanidine hydrochloride, without a reducing agent present, and gradually refolded by stepwise dialysis against arginine hydrochloride used as an aggregation suppressor. Each acidic chromatographic peak originally contained in the IgG1 drug substance was markedly increased by this stepwise refolding process, indicating that these acidic variants are conformational variants. However, no conformational changes were detected by small-angle X-ray scattering experiments for the whole IgG1, indicating that the conformational changes are minor. Chromatographic, thermal and fluorescence analyses suggested that the conformational changes are a localized denaturation effect centred around the aromatic amino acid regions. This study provides new insights into the characterization of acidic variants that are currently not fully understood.
    Keywords arginine ; case studies ; cation exchange chromatography ; denaturation ; dialysis ; drugs ; fluorescence ; guanidines ; immunoglobulin G ; small-angle X-ray scattering ; therapeutics ; Acidic variant ; Cation-exchange chromatography ; Conformational change ; Monoclonal antibody ; Refolding ; ANS ; CEX ; DSF ; DS ; DLS ; Rh ; HIC ; Dmax ; λmax ; p(r) ; Rg ; SEC ; SAXS ; Tm
    Language English
    Dates of publication 2023-11
    Publishing place Elsevier Inc.
    Document type Article ; Online
    ZDB-ID 1110-1
    ISSN 1096-0309 ; 0003-2697
    ISSN (online) 1096-0309
    ISSN 0003-2697
    DOI 10.1016/j.ab.2023.115302
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  6. Article ; Online: Energetic and Structural Insights into Phospholipid Transfer from Membranes with Different Curvatures by Time-Resolved Neutron Scattering.

    Nakano, Minoru / Nakao, Hiroyuki / Yoshida, Shigeharu / Fukuda, Masakazu / Imai, Manjiro / Ikeda, Keisuke

    The journal of physical chemistry letters

    2022  Volume 13, Issue 26, Page(s) 6024–6030

    Abstract: Understanding how lipid dynamics change with membrane curvature is important given that biological membranes constantly change their curvature and morphology through membrane fusion and endo-/exocytosis. Here, we used time-resolved small-angle neutron ... ...

    Abstract Understanding how lipid dynamics change with membrane curvature is important given that biological membranes constantly change their curvature and morphology through membrane fusion and endo-/exocytosis. Here, we used time-resolved small-angle neutron scattering and time-resolved fluorescence to characterize the properties and dynamics of phospholipids in vesicles with different curvatures. Dissociation of phospholipids from vesicles required traversing an energy barrier comprising positive enthalpy and negative entropy. However, lipids in membranes with high positive curvature have dense acyl chain packing and loose headgroup packing, leading to hydrophobic hydration due to water penetration into the membrane. These properties were found to lower the hydrophobic hydration enhancement associated with phospholipid dissociation and mitigate the acyl chain packing of lipids adjacent to the space created by the lipid dissociation, resulting in an increase in activation entropy. The results of this study provide important insights into the functions of biomembranes in relation to their dynamic structural changes.
    MeSH term(s) Lipid Bilayers/chemistry ; Membrane Fusion ; Neutrons ; Phospholipids/chemistry ; Scattering, Small Angle
    Chemical Substances Lipid Bilayers ; Phospholipids
    Language English
    Publishing date 2022-06-24
    Publishing country United States
    Document type Journal Article
    ISSN 1948-7185
    ISSN (online) 1948-7185
    DOI 10.1021/acs.jpclett.2c01080
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  7. Article ; Online: Mechanism of Protein-PDMS Visible Particles Formation in Liquid Vial Monoclonal Antibody Formulation.

    Soeda, Kohei / Arai, Kengo / Yamamoto, Tetsuya / Ofuji, Katsuya / Fukuda, Masakazu / Hashimoto, Daisuke / Yamanaka, Yuji

    Journal of pharmaceutical sciences

    2022  Volume 112, Issue 3, Page(s) 653–664

    Abstract: Visible particles (VPs) formation in liquid monoclonal antibody formulations is a critical quality issue. Formulations that include poloxamer 188 (PX188) as a surfactant are prone to the formation of VPs comprising aggregated complexes of protein and ... ...

    Abstract Visible particles (VPs) formation in liquid monoclonal antibody formulations is a critical quality issue. Formulations that include poloxamer 188 (PX188) as a surfactant are prone to the formation of VPs comprising aggregated complexes of protein and polydimethylsiloxane (PDMS; silicone oil) derived from primary containers. However, the mechanisms through which these VPs form are complicated and remain to be fully elucidated. This study demonstrates for the first time the dominant spot and pathway of protein-PDMS VP formation in a particular liquid vial formulation. Specifically, when a vial sealed with a PDMS-coated stopper is stored in an upright position under conditions whereby the antibody solution has become well-adhered to the stopper and an air phase exists in the vicinity, protein-PDMS aggregates form on the stopper and are then desorbed into the drug solution to be detected as VPs. Here, we evaluated the effects of several factors on VP formation: adhesion of the drug solution to the stopper, storage orientation, silicone coating on the stopper, vial material, and hydrophobicity of PX188. Remarkably, we found that changing any one of the factors could significantly affect VP formation. Our findings are instructive for better understanding the mechanisms of VP formation in vial products and can provide strategies for VP mitigation in biotherapeutics.
    MeSH term(s) Drug Packaging ; Antibodies, Monoclonal ; Silicone Oils
    Chemical Substances Antibodies, Monoclonal ; Silicone Oils
    Language English
    Publishing date 2022-09-30
    Publishing country United States
    Document type Journal Article
    ZDB-ID 3151-3
    ISSN 1520-6017 ; 0022-3549
    ISSN (online) 1520-6017
    ISSN 0022-3549
    DOI 10.1016/j.xphs.2022.09.027
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  8. Article ; Online: Paroxysmal Atrioventricular Block in a Patient With Pacemaker Following Long-Distance Casting During Sea Fishing.

    Ishiguchi, Hironori / Kaneyuki, Keita / Yoshiga, Yasuhiro / Fukuda, Masakazu / Okamura, Takayuki / Yano, Masafumi

    Circulation journal : official journal of the Japanese Circulation Society

    2022  Volume 86, Issue 7, Page(s) 1143

    MeSH term(s) Atrioventricular Block/etiology ; Atrioventricular Block/therapy ; Electrocardiography ; Humans ; Hunting ; Pacemaker, Artificial/adverse effects
    Language English
    Publishing date 2022-02-02
    Publishing country Japan
    Document type Journal Article
    ZDB-ID 2068090-9
    ISSN 1347-4820 ; 1346-9843
    ISSN (online) 1347-4820
    ISSN 1346-9843
    DOI 10.1253/circj.CJ-21-1028
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  9. Article ; Online: Chronic Expanding Hematoma in Device Pocket Developing 5 Years After Implantation.

    Uchida, Tomoyuki / Ishiguchi, Hironori / Ariyoshi, Toru / Fujita, Miho / Fukuda, Masakazu / Wada, Yasuaki / Yoshiga, Yasuhiro / Okamura, Takayuki / Yano, Masafumi

    Circulation reports

    2023  Volume 5, Issue 3, Page(s) 95–96

    Language English
    Publishing date 2023-02-03
    Publishing country Japan
    Document type Journal Article
    ISSN 2434-0790
    ISSN (online) 2434-0790
    DOI 10.1253/circrep.CR-22-0128
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  10. Article: Association between the atrial tachyarrhythmia recurrence period and long-term major adverse clinical events following catheter ablation for atrial fibrillation.

    Ishiguchi, Hironori / Yoshiga, Yasuhiro / Shimizu, Akihiko / Fukuda, Masakazu / Hisaoka, Masahiro / Hashimoto, Shintaro / Omuro, Takuya / Okamura, Takayuki / Kobayashi, Shigeki / Yano, Masafumi

    International journal of cardiology. Heart & vasculature

    2023  Volume 47, Page(s) 101228

    Abstract: Background: We previously demonstrated the clinical events in patients who underwent catheter ablation (CA) for atrial fibrillation (AF). Data on the association between the period of atrial tachyarrhythmia (ATA) recurrence after CA and long-term major ... ...

    Abstract Background: We previously demonstrated the clinical events in patients who underwent catheter ablation (CA) for atrial fibrillation (AF). Data on the association between the period of atrial tachyarrhythmia (ATA) recurrence after CA and long-term major adverse clinical events (MACE) remain unclear. In this study, we evaluated this issue in patients with systolic impairment (left ventricular ejection fraction < 50%) and heart failure with preserved ejection fraction (HFpEF).
    Methods: We retrospectively collected data from 81 patients with systolic impairment and 83 patients with HFpEF who underwent CA for AF at our institution (median follow-up: 4.9 [3.6, 6.6] years). In each group, we compared the cumulative incidence of long-term MACE (since 1 year after CA) between patients with and without ATA recurrence at three follow-up periods (3, 6 months, and 1 year after index CA). We evaluated the period of recurrence, which was the most beneficial predictor of MACE among the periods.
    Results: In the systolic impairment group, the cumulative long-term MACE incidence was significantly higher in patients with ATA recurrence than in those without it within 6 months and 1 year (P = 0.04 and P = 0.01, respectively). Recurrence within 1 year showed the highest feasibility for predicting long-term MACE (area under the curve with 95% confidence interval [CI]:0.73 [0.61-0.84]). However, there was no difference in the incidence of MACE between patients with and without recurrence in a group with HFpEF in each period.
    Conclusion: ATA recurrence within 1 year could predict long-term MACE in patients with systolic impairment, but not in patients with HFpEF.
    Language English
    Publishing date 2023-05-29
    Publishing country Ireland
    Document type Journal Article
    ZDB-ID 2818464-6
    ISSN 2352-9067
    ISSN 2352-9067
    DOI 10.1016/j.ijcha.2023.101228
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