Osmolality As A Valuable Tool In Formulation Studies For Advanced Therapies

By Paul Butler, Linda Buck, and Kristeena Wright, Ph.D.

Whilst osmolality is a compendial QC test for final product release, it’s also useful in formulation development and stability studies for drug products. It provides the excipient concentration and can confirm the soluble content of formulations. In this poster, the rapidly advancing field of cell therapy is discussed, where cryoprotective storage strategies are common. Data is presented which supports the value of osmolality measurements, derived via the freezing point depression method, for characterizing cryopreserved formulations.