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Optimisation of Lyophilisation Process Development in the Biopharmaceutical Industry

by biopharmajessica in Papers and Posters

An Application of the Lyotherm3 Frozen State Analyser

A great understanding of phase transitions which occur in the frozen state of the lyophilisation process is key as it promotes efficiency and stability. The most effective method of determining these phase transitions is Zsinφ, a metric of molecular mobility able to identify protein folding and reorientation events.

In this study, an analysis of the substitute Active Product Ingredient (API), human serum albumin, was carried out to demonstrate the sensitivity of the Zsinφ technique using the Lyotherm 3, a frozen state analytical instrument recently developed by BTL scientists. Collaborating both electrical (Zsinφ) and thermal (DTA) techniques the Lyotherm3 adds a new dimension and increases accuracy to data.

>>Download the application note (pdf)