A streamlined workflow for early phase formulation development of monoclonal antibodies comprising multi-attribute method and ligand binding assay

Key Points

• Early phase formulation development of monoclonal antibodies benefits from a streamlined workflow, enhancing efficiency.
• The proposed approach integrates a multi-attribute method with ligand binding assays, simplifying processes.
• Observational analysis across various parameters reveals the potential for reduced development times.
• Enhancements in the formulation process may lead to quicker availability of biopharmaceuticals to the market.