A generic anti-drug antibody assay for monoclonal antibody therapeutics with broad dynamic range eliminates the need for titer evaluation in preclinical studies.

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Bibliographic Details
Title: A generic anti-drug antibody assay for monoclonal antibody therapeutics with broad dynamic range eliminates the need for titer evaluation in preclinical studies.
Authors: Li H; BioAnalytical Sciences, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, USA. Electronic address: li.amy.al1@gene.com., Foley AR; BioAnalytical Sciences, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, USA., Shim J; BioAnalytical Sciences, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, USA., Siradze K; BioAnalytical Sciences, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, USA., Webb-Vargas Y; Nonclinical Biostatistics, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, USA., Sperinde G; BioAnalytical Sciences, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, USA., Fischer SK; BioAnalytical Sciences, Genentech, Inc., 1 DNA Way, South San Francisco, CA 94080, USA.
Source: Journal of pharmaceutical and biomedical analysis [J Pharm Biomed Anal] 2024 Oct 15; Vol. 249, pp. 116364. Date of Electronic Publication: 2024 Jul 15.
Publication Type: Journal Article
Journal Info: Publisher: Elsevier Science Country of Publication: England NLM ID: 8309336 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1873-264X (Electronic) Linking ISSN: 07317085 NLM ISO Abbreviation: J Pharm Biomed Anal Subsets: MEDLINE
Database: MEDLINE Ultimate
Description
ISSN:1873-264X
DOI:10.1016/j.jpba.2024.116364