Guidance for Industry: Immunogenicity Assessment for Therapeutic Protein Products [excerpts

Abstract

Biotechnology Law ReportVol. 32, No. 3 DocumentsGuidance for Industry: Immunogenicity Assessment for Therapeutic Protein Products [excerpts]Published Online:13 Jun 2013https://doi.org/10.1089/blr.2013.9927AboutSectionsPDF/EPUB ToolsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail FiguresReferencesRelatedDetailsCited ByDiscrete, Chiral Polymer–Insulin Conjugates20 September 2022 | Journal of the American Chemical Society, Vol. 100Utility of Three Flow Imaging Microscopy Instruments for Image Analysis in Evaluating four Types of Subvisible Particle in BiopharmaceuticalsJournal of Pharmaceutical Sciences, Vol. 98Protein’s Protein Corona: Nanoscale Size Evolution of Human Immunoglobulin G Aggregates Induced by Serum Albumin13 July 2022 | ACS Applied Materials & Interfaces, Vol. 14, No. 29Phase 1b study of anti-NaPi2b antibody-drug conjugate lifastuzumab vedotin (DNIB0600A) in patients with platinum-sensitive recurrent ovarian cancerGynecologic Oncology, Vol. 158, No. 3Literature review in support of adjuvanticity/immunogenicity assessment of proteinsEFSA Supporting Publications, Vol. 16, No. 1Current possibilities of liquid chromatography for the characterization of antibody-drug conjugatesJournal of Pharmaceutical and Biomedical Analysis, Vol. 147Pharmacological vs . classical approaches in the design of first in man clinical drug trials6 October 2017 | British Journal of Clinical Pharmacology, Vol. 83, No. 12Antibody-drug conjugate characterization by chromatographic and electrophoretic techniquesJournal of Chromatography B, Vol. 1032Immunogenicity/Hypersensitivity of Biologics14 November 2013 | Toxicologic Pathology, Vol. 42, No. 1 Volume 32Issue 3Jun 2013 InformationCopyright 2013, Mary Ann Liebert, Inc.To cite this article:Guidance for Industry: Immunogenicity Assessment for Therapeutic Protein Products [excerpts].Biotechnology Law Report.Jun 2013.172-185.http://doi.org/10.1089/blr.2013.9927Published in Volume: 32 Issue 3: June 13, 2013PDF download