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Closing Characterisation Gap Between API and Formulation Components

This whitepaper will provide an introduction to high-purity carbohydrates often used for applications such as stabilisation, modulation, and cryopreservation, comparing the old paradigm that formulation components are inactive ingredients with limited functionality with the new paradigm, which suggests these components play a significant role in therapeutic stability, quality, potency, immunogenicity, and bioavailability.

It will also provide analytical results of T-104-4 Trehalose, S-124-1-MC Cane Sucrose, and S-124-2-MC Beet Sucrose, as well as the findings of two case studies, one on monoclonal antibody (mAb) product quality and another regarding glucan versus endotoxins.