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Preclinical Thermal Analysis

Thermal Analysis During the Preclinical Phase for a Contract Manufacturing Company and their Client

The Challenge

Our client was collaborating with another firm in early development of their new product’s lyophilized presentation.  They needed to ascertain the critical design parameters to conduct further lyophilization cycle development in order to produce engineering and then clinical batches.  As is often the case during preclinical periods, they were under significant time, monetary and drug substance supply constraints.

The Solution

Determine critical thermal properties of the formulation, including glass transition or eutectic melting temperature, and/or collapse temperature by differential scanning calorimetry (DSC) and freeze dry microscopy (FDM).

The Results

Two thermal events were identified in the DSC thermograms – a glass transition at -43.3°C and the onset of the eutectic melt at -3.34°C.  FDM confirmed that the glass transition at -43.3°C is the limiting thermal event for lyophilization cycle development.

The Conclusions

In less than 1 week, BioConvergence scientists developed the thermal analysis profile required to set the initial primary drying conditions (temperature and pressure) for the new product formulation based on the most critical temperature.  Ultimately, our client conserved their scarce drug substance, reduced time spent in lyophilization process development and maintained their aggressive timeline for initial clinical supply.


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