Development challenges of high concentration monoclonal antibody formulations.

High concentration monoclonal antibody drug products represent a special segment of biopharmaceuticals. In contrast to other monoclonal antibody products, high concentration monoclonal antibodies are injected subcutaneously helping increase patient compliance and reduce the number of hospital patient visits. It is important to note that a high protein concentration (≥50 mg/mL) poses a challenge from a product development perspective. Colloidal properties, physical and chemical protein stability should be considered during formulation, primary packaging and manufacturing process development as well as optimization of other dosage form-related parameters. The aim of such development work is to obtain a drug product capable of maintaining appropriate protein structure throughout its shelf-life and ensure proper and accurate dosage upon administration.