Applied Photophysics Limited

This project is a follow on project to: "Practical Applications of circular dichroism spectroscopy for biopharmaceuticals." Reference number 102611 which finished in October 2017. Higher Order Structure (HOS) of a biopharmaceutical is a key quality attribute required to be controlled throughout the development and manufacture of a biologic drug or vaccine...

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High throughput protein stability analysis systems for biopharma

"To ensure product safety and efficacy, protein therapeutic critical quality attributes must remained within tolerances for the duration of the shelf life of the product, as well as during transportation, storage and use. Consequently development of and testing for long term stability of the protein drug product is a major focus of biotherapeutic developm...

Circular dichroism (CD) spectroscopy is an analytical technique routinely used in the biopharmaceutical industry to study the effects of manufacturing, formulation, and storage conditions on protein conformation and stability. The difficulty in data interpretation of CD is limited to demonstrating conformational comparability after a manufacturing/formula...

Knowledge of a biopharmaceutical product’s higher order structure (HOS) and conformational dynamics, and how these relate to it’s mode of action and/or degradation, are central to enable effective and streamlined biopharmaceutical development through QbD-based approaches. Hydrogen deuterium exchange mass spectrometry (HDX MS) is a technique increasingly u...

Eight of the predicted top-ten drugs by revenue in 2016 will be biotherapeutics and as early as 2014, 50% of the top-100 pharmaceutical products will be accounted for by vaccines and biotherapeutics. Understandably, pharmaceutical companies are competing to establish new biotherapeutic drug pipelines, both as innovator and generic manufacturers. The socie...