Regulatory and strategic considerations for addressing immunogenicity and related responses in biopharmaceutical development programs.

ABSTRACT: The last three decades have seen the biotherapeutic drug market evolve from promising concept to market dominance in a range of clinical indications. This growth has been spurred by the success of established drug classes like monoclonal antibodies, but also by the introduction of biosimilars, and more recently, multiple novel cell and gene therapies. Biotherapeutic drug development presents many unique challenges, but unintended immune responses are among the most common reasons for program attrition. Anti-drug antibodies can impact the safety and efficacy of drug products, and related immune responses, like the cytokine release syndrome that occurred in the infamous TGN-1412 clinical trial, can be challenging to predict with nonclinical models. For this reason, it is important that devel

SUBMITTER: Vandivort TC 

PROVIDER: S-EPMC8057416 | biostudies-literature | 2020 Jun

REPOSITORIES: biostudies-literature