The art of making a comprehensive stability study

Abstract: There is a need for harmonisation of stability study designs of monoclonal antibodies. Monoclonal antibodies (mAbs) are widely used in treatments for various diseases. Like all drugs, their quality must be verified through stability studies. The ICH guidelines give general recommendations regarding stability studies of antibodies, and specifications should often be determined on a case-by-case basis. More detailed requirements may need to be defined to make better designed stability studies for mAbs. This report aims to produce a broader understanding of the parameters that should be included in mAb stability studies and give a proposal for a comprehensive stability study design. The information for this report was obtained through literature studies including amongst other the ICH guidelines and several newly published articles regarding size-exclusion chromatography and its application in stability studies. The results showed that the existing guidelines regarding stability studies of biopharmaceutical are very general. Therefore, stability test focusing on the physicochemical stability of mAbs in clinical settings are often missed. This additional stability test can increase the understanding of the analyte and may facilitate the work of health personnel. Even though it is difficult to make a study design that fit all types of mAbs, there are opportunities for improvement in the guidelines as they are today in order to make a more comprehensive stability study design. In conclusion, there is a need for development in stability study designs regarding mAbs. To create more comprehensive stability studies new recommendation may have to be added that may contribute to a harmonisation of the stability study designs