Formulation development: The key to product stability

The development of any biopharmaceutical begins with CMC (Chemistry Manufacturing Control). CMC is essential to provide the product for preclinical testing and subsequent clinical testing. The first actions in CMC are to develop a manufacturing process and analytical development, to provide the assays to monitor and control the manufacturing process and product. An integral part of process and analytical development should be formulation development. Formulation development involves identifying a combination of the active biotherapeutic and excipients to provide a product that is both stable and patient compatible.