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Spore-inspired excipients for the formulation of biopharmaceuticals

last modified Jul 21, 2017 02:50 PM
Paper published in the International Journal of Pharmaceuticals
Spore-inspired excipients for the formulation of biopharmaceuticals

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Bacterial spores are remarkable cellular structures which can vary in shape, colour, morphology and even biological function, but they all have a common trait: their unique resistance to harsh external conditions, including desiccation, mechanical stress, extreme temperatures and pH, UV and gamma radiation, enzymatic aggression, malnutrition and chemical stressors.

Spore robustness is conferred by its unique structure and chemical composition. At the molecular level, one small organic acid – dipicolinic acid – is thought to promote the stability of essential spore-core located proteins during dormancy and spore germination, perhaps by minimising thermal-induced motion and the likelihood of denaturation and aggregation.

Recent work by postdoctoral researcher Dr. Iris L. Batalha, within the scope of a collaborative project between Dr. Graham Christie's group and the formulation sciences team at MedImmune, has shown that these organic acids have the potential to be successfully used as pharmaceutical excipients, presenting viscosity and phase-separation reducing properties of high concentration antibody formulations.

The work originated a provisional patent and has recently been published in International Journal of Pharmaceuticals.

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