Hiroko Shibata

Kawasaki, 2109501, Japan

Last Updated: 09/26/2026

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Found 47 publications

Flow imaging for particle characterization and quantification in biologicals: A perspective from the Japanese Biopharmaceutical Consortium.

Flow imaging for particle characterization and quantification in biologicals: A perspective from the Japanese Biopharmaceutical Consortium.

Journal: Journal of pharmaceutical sciences

Published: February 12, 2026

Development of tCAP(N3): Affinity Peptide-Aided, pH-Triggered Strategy for Site-Specific Native IgG Modification.

Development of tCAP(N3): Affinity Peptide-Aided, pH-Triggered Strategy for Site-Specific Native IgG Modification.

Journal: Chemistry (Weinheim an der Bergstrasse, Germany)

Published: October 15, 2025

Integrative structural insights into the IgG-FcRn interactions revealed by engineered FcRn-immobilized affinity chromatography.

Integrative structural insights into the IgG-FcRn interactions revealed by engineered FcRn-immobilized affinity chromatography.

Journal: Communications biology

Published: August 15, 2025

Temporal Trends in the Prescription of Biosimilars and the Status of Switching from Original Biologics to Biosimilars at Individual and Institutional Levels in Japan.

Temporal Trends in the Prescription of Biosimilars and the Status of Switching from Original Biologics to Biosimilars at Individual and Institutional Levels in Japan.

Journal: Therapeutic innovation & regulatory science

Published: May 16, 2025

Evaluation of anti-drug antibodies against therapeutic monoclonal antibodies and related product in Japanese patients with rheumatoid arthritis and their clinical impact.

Evaluation of anti-drug antibodies against therapeutic monoclonal antibodies and related product in Japanese patients with rheumatoid arthritis and their clinical impact.

Journal: European journal of pharmaceutical sciences : official journal of the European Federation for Pharmaceutical Sciences

Published: April 22, 2025

Characterization of Biosimilar Monoclonal Antibodies and Their Reference Products Approved in Japan to Reveal the Quality Characteristics in Post-approval Phase.

Characterization of Biosimilar Monoclonal Antibodies and Their Reference Products Approved in Japan to Reveal the Quality Characteristics in Post-approval Phase.

Journal: BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy

Published: April 09, 2025

Higher-order structure comparison of the reference and biosimilar products using spectral distance calculation on the circular dichroism spectra.

Higher-order structure comparison of the reference and biosimilar products using spectral distance calculation on the circular dichroism spectra.

Journal: Journal of pharmaceutical sciences

Published: January 31, 2025

Survey and Establishment of Points to Consider for Application of Analytical Techniques to Evaluate Protein Aggregates and Insoluble Particles in Biopharmaceuticals: Experiences in Japan Biopharmaceutical Consortium.

Survey and Establishment of Points to Consider for Application of Analytical Techniques to Evaluate Protein Aggregates and Insoluble Particles in Biopharmaceuticals: Experiences in Japan Biopharmaceutical Consortium.

Journal: The AAPS journal

Published: December 26, 2024

Specific peptide conjugation to a therapeutic antibody leads to enhanced therapeutic potency and thermal stability by reduced Fc dynamics.

Specific peptide conjugation to a therapeutic antibody leads to enhanced therapeutic potency and thermal stability by reduced Fc dynamics.

Journal: Scientific reports

Published: May 30, 2023

Comparison of Immunochemical Reactions of Infliximab Innovator and Biosimilars on an Infliximab Detection Kit Used for Therapeutic Drug Monitoring.

Comparison of Immunochemical Reactions of Infliximab Innovator and Biosimilars on an Infliximab Detection Kit Used for Therapeutic Drug Monitoring.

Journal: Biological & pharmaceutical bulletin

Published: April 02, 2023

Investigation of Foreign Particles in Moderna COVID-19 Vaccine

Investigation of Foreign Particles in Moderna COVID-19 Vaccine

Journal: Yakugaku zasshi : Journal of the Pharmaceutical Society of Japan

Published: July 31, 2022

Evaluation of the analytical performance of anti-SARS-CoV-2 antibody test kits distributed or developed in Japan.

Evaluation of the analytical performance of anti-SARS-CoV-2 antibody test kits distributed or developed in Japan.

Journal: Bioanalysis

Published: March 02, 2022

Showing 1-12 of 47

Last Updated: 09/26/2026