Formulation, Drug Product, and Delivery: Considerations for Fc‐Fusion Proteins

Lyophilized Biologics

“…Fcfusion products have demonstrated inferior stability compared to naturally existing antibodies and thus require additional stabilizers in their lyophilized formulations. The structural compatibility between Tc and Fc regions has been discussed among possible sources of instability [6,19]. Likewise, the conjugation of antibodies with small molecule pharmaceuticals results in less stable molecules than the original antibodies.…”

Accelerated Formulation Development of Monoclonal Antibodies (mAbs) and mAb-Based Modalities: Review of Methods and Tools

“…148 Usually, other modalities are less stable than IgG, and a wider screening is required to find the stable solution for each molecule since the modifications and mixture of different domains produce a construct with hard to predict stability properties. [148][149][150] After wide screening and identification of a stable formulation, a more narrow range of components can be tested with higher resolution, that is, with more data points between formulation factor variables. Commercial formulation development normally comes with the studies of several formulations and stress conditions to explore.…”