High-Purity, Low-Endotoxin Carbohydrates, Parenteral Grade Excipients and Highly Potent APIs
Closing Characterisation Gap Between API and Formulation ComponentsPfanstiehl
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.
Download this whitepaper to find out about these topics and others, including a short biography of Pfanstiehl, applications of high-purity carbohydrates, and lists of approved drugs formulated with trehalose, mAbs, and antibody drug conjugates ( ADC) using trehalose and sucrose.