Characterization Corner – A New Weapon in Formulation Development

Matt McGann, Field Applications & Marketing Manager, RedShift BioAnalytics, Inc.

At the 2019 Colorado Conference on Protein Stability held in Breckenridge CO, industry experts, key opinion leaders, and researchers gathered to discuss challenges and advances in formulation development of biologics. Among the work presented, several studies using computational modeling to elucidate formulation stability indicated that our understanding is still a long way from being prescriptive in formulation design. When discussing aggregation and amyloidosis, it was highlighted that the role of reversible self-association and aggregation is far more complex than envisioned. Many talks highlighted the breadth of analytical technologies that are being used to understand the complexities of biopharmaceutical design and development. A significant observation throughout the conference was that sometimes the most stable formulation is not, in fact, the most suitable, as it is ultimately more important to formulate a drug product that is fit for purpose. A good example of this is the use of citrate buffer, which is known to cause discomfort at the injection site in patients.