Long-term stability predictions of therapeutic monoclonal antibodies in solution using Arrhenius-based kinetics.

ABSTRACT: Long-term stability of monoclonal antibodies to be used as biologics is a key aspect in their development. Therefore, its possible early prediction from accelerated stability studies is of major interest, despite currently being regarded as not sufficiently robust. In this work, using a combination of accelerated stability studies (up to 6 months) and first order degradation kinetic model, we are able to predict the long-term stability (up to 3 years) of multiple monoclonal antibody formulations. More specifically, we can robustly predict the long-term stability behaviour of a protein at the intended storage condition (5 °C), based on up to six months of data obtained for multiple quality attributes from different temperatures, usually from intended (5 °C), accelerated (25 °C) and stress c

SUBMITTER: Kuzman D 

PROVIDER: S-EPMC8519954 | biostudies-literature | 2021 Oct

REPOSITORIES: biostudies-literature