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Improved biopharmaceuticals using X-rays

17 December 2019, 12:50

Biological medicines are vital to many people with lifelong diseases, such as diabetes. However, these medicines are often difficult to manage and limit the patient's quality of life – something that hopefully is now possible to change with our research. NextBioForm cooperates with MAX IV in Lund, a facility for measurements with high-intensity X-rays. Thanks to a close cooperation between the researchers linked to NextBioForm and MAX IV new research findings can be developed that provide even more in-depth knowledge about the formulation of biological medicines.

Using the technique small-angle X-ray scattering (SAXS) we can study the size and shape of pharmaceutical ingredients on a molecular scale, its internal structure, and what happens when it undergoes change due to for example heating. SAXS can be applied to a broad range of substances such as particles in solution, gels, powders, tablets, tissue or bone samples. In other words, it is possible to study your samples in the very same condition as in the final product.

 “At the centre we work on developing technology in order to measure stability in different ways, investigate what triggers destabilization, and develop new formulation platforms,” says Anna Fureby, the centre director at NextBioForm.

In life science, the research using X-rays has mostly been focused on studies of the individual active pharmaceutical ingredients (API) in pure crystal form rather than in the finished formulation. But SAXS allows examination of formulations where the protein and pharmaceutical ingredients retain their functionality. We can study a biological pharmaceutical formulation all the way from its individual ingredients to the entire complex formulations. With this method, we can retrieve more and more valuable information compared to conventional studies where the materials are constrained in a crystalline form. Thus, there is both a need for developing new sample environments to meet the needs when studying complex formulations and for demonstration on how these facilities can be used in industrial formulation research.

In NextBioForm we are involved in developing a methodology for protein formulation studies at the CoSAXS instrument at MAX IV Laboratory in Lund which saw first light in November 2019. This instrument will meet the demands of a large and broad community of users. However, relevant sample environments must be developed in order to make use of this instrument’s full potential, therefore we are aiming to ensure that the right tools exist and are developed for NextBioForm as well as for other project's needs.