Freeze-dried products are normally either completely amorphous or consisting of a homogenous mixture of amorphous and crystalline components. When deliberate amorphous phases are included in a product, it is commonly a more demanding task to ensure robust quality and stability compared to the case of crystalline products. By that, it is especially critical to build thorough understanding on the interplay between the freeze-drying manufacturing process parameters together with the chosen formulation components and the quality of the produced formulation.
Our team of experts are experienced in assisting with the background to properties like glass transition temperature (Tg) and Tg-prime and their relation to the formulation composition and the freeze-drying process parameters. Our teams are experienced in working with a wide range of materials including polymers, small and large molecules and ensuring adequate characterization packages are generated during freeze-drying development including analysis of characterization of the glassy state properties, evaluation of the powder cake texture and appearance, evaluation of the content of residual solvents and not the least determination of the level of amorphicity including polymorph identification of possible crystalline components. The same characterisation package is normally used also in support to stability studies in order to evaluate the initial quality followed by long term stability of the developed products.
Thomas has 30+ years’ experience within global pharmaceutical industry, encompassing project support from early pre-clinical phase trough all phases of late-stage development and registration for market. Thomas main expertise are within Solid -State and Material Science areas, including knowledge-building on the interrelationship between physical properties, stability and functionality of formulations and products. Today, Thomas is responsible for the management of our Inhalation and Solid-State services.