With the increasing prominence of biopharmaceutical products in the modern therapeutic landscape, it has become vitally important to ensure the manufacture of these products is carried out reliably and efficiently. Therefore, the FDA introduced the concepts of quality by design (QbD) into the cGMP regulations in 2004. These guidelines provide the framework by which pharmaceutical companies can design their products, processes, and control procedures to ensure that a product has all the attributes considered paramount to its safety and efficacy –
the critical quality attributes (CQAs). Omar Musleh at SGS Life Sciences explores how to use these to develop a life-saving biologic.