Nanoparticulate Impurities in Excipients
WEBINAR
One main reason for using excipients is to stabilize the active pharmaceutical ingredient, ensuring an effective and safe therapy. Pharmaceutical grade sucrose, an important and commonly used stabilizer, contains nanoparticulate impurities (NPIs) of 100-200 nm size originating from the starting raw material. In this webinar, the scientists behind the discovery discuss the characteristics of these NPIs, explain their impact on aggregate/particle analytics, and show, with the example of antibodies, that NPIs are a threat to protein stability. Their research has triggered the development of improved sucrose grades, that are low in NPIs to reduce the risk of unwanted instability.
In this webinar you will learn about:
- The role of sucrose as a stabilizer in pharmaceuticals
- The presence and characteristics of nanoparticulate impurities (NPIs) in pharmaceutical-grade sucrose
- The impact of NPIs on protein stability
- Sucrose with low NPI content
Pharma and biopharma manufacturing
- Solid Formulation Strategies
Czas trwania:48min
Język:English
Sesja 1:pokazane November 5, 2020
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