04.05.21 -- Remove Formulation Development From The Critical Path

Determining size homogeneity of a monoclonal antibody (mAb) in solution is important for comparability and characterization of these medications. For this study, an IgG1 antibody was cleaved into antigen-binding fragments using pepsin and papain digestion respectively, followed by Protein A purification.

As the product development program progresses to Phase 3 clinical stage, formulation development is required to ensure drug product quality and stability during manufacturing, storage, and clinical administration. This Q&A discusses the utilization of automation, specifically the Uncle platform, during formulation development.

For therapies with early success now progressing toward commercial manufacturing, understanding the operational, regulatory, and quality connections is critical for successful filing and launch. This case study proposes an approach for process characterization to produce a monoclonal antibody (mAb), specifically at the drug substance biomanufacturing step, to improve efficiency and effectiveness.