Recombinant Human Serum Albumin as an Excipient for Preventing Protein Aggregates and Particles

摘要

Human serum albumin (Alb) has historically been used extensively in the formulation of a wide range of proteins. The potential impurities due to sourcing of the material from serum and the batch-to-batch variation of the Alb have however raised both regulatory and technical challenges. These challenges can be alleviated by a recombinant Alb (rAlb). The ability of rAlb to minimize the predispositions of certain proteins to aggregate and fibrillate will be shown using the peptides Insulin and Enfuvirtide and the monoclonal antibody Tocilizumab. The investigative technologies used were micro flow imaging for micron, or sub-visible particle, evaluation and Thioflavin T assay with fluorescence detection for fibrillation, or visible particle, assessment. The stabilizing effect of rAlb will be indicated to be different to that of polysorbate as well as concentration and pH dependent.