MHC-associated peptide proteomics enabling highly sensitive detection of immunogenic sequences for the development of therapeutic antibodies with low immunogenicity

Author:

Sekiguchi Nobuo1,Kubo Chiyomi1,Takahashi Ayako1,Muraoka Kumiko1,Takeiri Akira1ORCID,Ito Shunsuke1,Yano Mariko1,Mimoto Futa1,Maeda Atsuhiko1,Iwayanagi Yuki1,Wakabayashi Tetsuya1ORCID,Takata Shotaro1,Murao Naoaki1,Chiba Shuichi1,Ishigai Masaki1

Affiliation:

1. Research Division, Fuji Gotemba Research Labs, Chugai Pharmaceutical Co., Ltd., Gotemba, Shizuoka, Japan

Publisher

Informa UK Limited

Subject

Immunology,Immunology and Allergy

Reference46 articles.

1. Immunotoxicity and Immunogenicity of Biopharmaceuticals: Design Concepts and Safety Assessment

2. Immunogenicity and its Impact on Benefit/Risk Considerations in the Authorisation of Biopharmaceuticals

3. A fit-for-purpose strategy for the risk-based immunogenicity testing of biotherapeutics: a European industry perspective

4. European Medicines Agency, Committee for Medicinal Products for Human Use (CHMP). Guideline on immunogenicity assessment of monoclonal antibodies intended for in vivo clinical use. [Online]. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500128688.pdf.

5. US Food and Drug Administration, Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER). Guidance for industry; immunogenicity assessment for therapeutics protein products. [Online] https://www.fda.gov/downloads/drugs/guidances/ucm338856.pdf.

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