Sagacity in antibody humanization for therapeutics, diagnostics and research purposes: considerations of antibody elements and their roles.

ABSTRACT: The humanization of antibodies for therapeutics is a critical process that can determine the success of antibody drug development. However, the science underpinning this process remains elusive with different laboratories having very different methods. Well-funded laboratories can afford automated high-throughput screening methods to derive their best binder utilizing a very expensive initial set of equipment affordable only to a few. Often within these high-throughput processes, only standard key parameters, such as production, binding and aggregation are analyzed. Given the lack of suitable animal models, it is only at clinical trials that immunogenicity and allergy adverse effects are detected through anti-human antibodies as per FDA guidelines. While some occurrences that slip through

SUBMITTER: Ling WL 

PROVIDER: S-EPMC7990220 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature