With an example explain the development …

Therapeutic proteins as drug substance may be provided in individual containers prior to the formulation/filling process. To ensure homogeneity, the therapeutic protein may need to be gently mixed in a vessel prior to filling. In this case, mixing may be necessary. Different types of methods utilized for mixing the material may be employed. Examples of mixing techniques include impellers on a shaft with open processing, suspended impellers, or magnetic stir bars at the bottom of the mixing vessel. It is likely that the mixing process will need to be scaled down for testing in the laboratory. Impeller mixing as well as mixing with magnetic stir bars may be simulated at a small scale. The investigator should determine the appropriate mixing speeds that will be utilized in manufacturing and determine if these processes adversely affect the protein. Studies have been reported for therapeutic proteins that have been mixed using magnetic stir bars, and it was demonstrated that this type of mixing may induce aggregates (Kiese et al., 2008).