5 Considerations For Buffer Optimization During Biologics Pre-Formulation

By Stefanie Kall

Formulation development is a vital part of the drug development process. The pre-formulation stage is particularly crucial in maintaining the solubility and activity of new biologic drug candidates, and involves determining the appropriate pH, salt concentrations, and excipients to prevent protein aggregation or denaturation. Factors such as pH/buffering, salt, excipients, downstream assay requirements, and material cost are key considerations in pre-formulation. These elements affect everything from protein stability to the cost of producing the drug. Tools such as the Prometheus Panta can support researchers in evaluating how buffer components enhance the stability of their therapeutics.