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The role of the Standardisation Science section is to develop suitable formulations and lyophilisation processing conditions in order to facilitate the reference material program of the Institute. As such the section is equipped and its scientists skilled to deliver both analytical and pilot process experimental work and also advice related to the areas of the formulation and lyophilisation of biological materials.
In particular, the determination of critical glass transition and eutectic temperatures of formulations is critical and the impact of formulation choices upon these parameters is very important to successful freeze drying.