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.Read more...
Drug products are manufactured to an extremely high standard to maintain product safety when taken by patients. Specifications used throughout the manufacturing process cover not only the drug itself, but also the level of potential impurities (chemical, solvent, or polymorph), which are set to limits that are monitored by regulatory bodies to uphold safety and product quality requirements. X-ray powder diffraction is a key analytical technique in the pharmaceutical industry for characterising drug compounds. This is used for throughout the development process to fingerprint compounds and quantify impurities.Read more...
Along with many pharmaceutical materials, sodium diclofenac, a commonly used painkiller, can crystallise in many different forms depending on the manufacturing and formulation conditions. Each crystalline form may have very different biological and physical properties including bioavailability, drug delivery mechanism and shelf-life. Full characterisation and optimisation of solid forms of an API is therefore critical.Read more...
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