A case study of a bispecific antibody manufacturability assessment and optimization during discovery stage and its implications.

ABSTRACT: The manufacturability assessment and optimization of bispecific antibodies (bsAbs) during the discovery stage are crucial for the success of the drug development process, impacting the speed and cost of advancing such therapeutics to the Investigational New Drug (IND) stage and ultimately to the market. The complexity of bsAbs creates challenges in employing effective evaluation methods to detect developability risks in early discovery stage, and poses difficulties in identifying the root causes and implementing subsequent engineering solutions. This study presents a case of engineering a bsAb that displayed a normal solution appearance during the discovery phase but underwent significant precipitation when subjected to agitation stress during 15 L Chemistry, Manufacturing, and Control (CM

SUBMITTER: Wang S 

PROVIDER: S-EPMC11259756 | biostudies-literature | 2024 Jul

REPOSITORIES: biostudies-literature