Milton, Mark, Kroenke, Mark, Kumar, Seema, Bame, Eris and White, Joleen (2021) Immunogenicity Risk Assessment for Multi-specific Therapeutics. The AAPS journal, 23 (6). p. 115. ISSN 1550-7416

Abstract

The objective of this manuscript is to provide the reader with a hypothetical case study to present an immunogenicity risk assessment for a multi-specific therapeutic as part of Investigational New Drug (IND) application. In order to provide context for the bioanalytical strategies used to support the multi-specific therapeutic presented herein, the introduction focuses on known immunogenicity risk factors. The subsequent hypothetical case study applies these principles to a specific example HC-12, based loosely on anti-TNFα and anti-IL-17A bispecific molecules previously in development, structured as an example immunogenicity risk assessment for submission to health authorities. The risk of higher incidence and safety impact of anti-drug antibodies (ADA) due to large protein complexes is explored in the context of multi-specificity and multi-valency of the therapeutic in combination with the oligomeric forms of the targets.

Item Type:	Article
Date Deposited:	18 Jan 2022 00:45
Last Modified:	18 Jan 2022 00:45
URI:	https://oak.novartis.com/id/eprint/44711