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Industrial Liaison Group:
Tel: +44 (0) 1235 778797
E-mail: [email protected]
Synchrotron techniques for drug development
So where do synchrotron research techniques fit into all of this? Depending on the nature of the problem, a wide variety of options are available here at Diamond which provide different, and very often complementary, information to gain an greater understanding of the system in question.
Popular techniques for investigating structure in pharmaceutical formulations include X-ray diffraction and crystallography that are able to provide nanoscale structural information, small angle X-ray scattering which can provide information about phase behaviour and microstructure in soft systems, typically solutions, suspensions, gels and emulsions. X-ray absorption spectroscopy is able to provide a direct probe of the chemical environment within a sample which could be a crystalline or amorphous solid, a liquid or even a gas. High resolution measurements such as powder diffraction and X-ray fluorescence also permit chemical mapping of samples. X-ray imaging and related techniques can provide direct images of samples including tomographic studies to examine complex internal structures in tablets or capsules or even imaging devices.
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.
We’re always happy to discuss any enquiries or talk about ways in which access to Diamond’s facilities may be beneficial to your business so please do give us a call on 01235 778797 or send us an e-mail. You can keep in touch with the latest development by following us on Twitter @DiamondILO orLinkedIn.
Diamond Light Source is the UK's national synchrotron science facility, located at the Harwell Science and Innovation Campus in Oxfordshire.
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