Drug Development for Industry

Below you can find some examples from our Industrial Liaison clients who have employed the techniques available at Diamond to their drug development research. From GSK characterising drug components, SAFC Pharmophix looking at polymorphism studies through to Porton Biopharma characterising variants in clinical grade biopharmaceuticals, the applications are many. 

Addressing manufacturing issues

To ensure patient safety and product quality, strict specifications cover the drug itself along with the levels of potential impurities (chemical, solvent or polymorph) present. Tolerance limits are set and closely monitored by regulatory bodies to ensure the production of safe and effective and medicines. 

Key to the characterisation of drug compounds, X-ray diffraction is a powerful technique that can be used to fingerprint compounds and identify impurities with high specificity and is widely used throughout the drug development process. GSK development scientists worked with Diamond on the detection limit of a solvate within a manufactured drug batch and by making use of the high sensitivity techniques available at Diamond, they were able to gain additional confidence in the reproducibility of their manufacturing process. Read all about this example in our case study for further information.   

Characterising variants in clinical grade biopharmaceuticals

Medicinal products extracted from biological sources, called biopharmaceuticals or biologics, must be carefully produced to ensure that only high purity active material is generated. Biopharmaceutical manufacturing processes can have an impact on the amount of product-related variants in the final clinical material. Understanding and controlling amounts of these product-related variants is a major challenge in the development of biopharmaceutical products.

Scientists from Porton Biopharma made use of the Diamond small angle X-ray scattering (SAXS) data collection and analysis service to characterise the product variant. This highly-sensitive technique allowed Porton Biopharma to analyse the variant in solution and provide reassurance to regulatory bodies that the subtle changes did not hinder the activity of the drug.

Controlling gelation in formulations using additives

Gels are used in a wide range of formulation types ranging from pharmaceutical formulations to personal care products, cosmetics and foods, among others. Already used in medical applications, cellulose is considered a highly effective additive for modifying the rheology of suspensions and solutions as a thickening agent. A team from the University of Bath used small angle X-ray scattering (SAXS) at Diamond to probe gelation behaviour of oxidised cellulose, a biodegradable and easily dispersible form of cellulose. The gels were investigated under a range of formulation conditions including varying salt concentration, variable salt types, the presence of low molecular weight alcohols, varying surfactant types and pH levels to monitor changes in gel behaviour. Prof. Karen Edler from the University of Bath describes the work in a case study example.