Developability assessment at early-stage discovery to enable development of antibody-derived therapeutics.

ABSTRACT: Developability refers to the likelihood that an antibody candidate will become a manufacturable, safe and efficacious drug. Although the safety and efficacy of a drug candidate will be well considered by sponsors and regulatory agencies, developability in the narrow sense can be defined as the likelihood that an antibody candidate will go smoothly through the chemistry, manufacturing and control (CMC) process at a reasonable cost and within a reasonable timeline. Developability in this sense is the focus of this review. To lower the risk that an antibody candidate with poor developability will move to the CMC stage, the candidate's developability-related properties should be screened, assessed and optimized as early as possible. Assessment of developability at the early discovery stage sho

SUBMITTER: Zhang W 

PROVIDER: S-EPMC9847343 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature