Abstract: Modeling of Degradation Chemistry at AstraZeneca

Modeling of Degradation Chemistry at AstraZeneca

SOS-2015 Astra Zeneca

One key step in the drug product development process is to select which aggregation state the active pharmaceutical ingredient (API) should have to obtain optimal product and process performance. The objective at the form selection step is to choose the preferred aggregation state of the API with respect to a large number of requirements on the material. Requirements can be expressed in terms of high level materials performance characteristics.

  • Consistent and predicable bioavailability
  • Robust and scalable manufacturing process
  • Predicable chemical and physical stability

In this talk the emphasis is on how computational methods could be used to understand the risk associated to chemical degradation of the API. Autoxidation and oxidation of hetro atoms will be discussed.