Assessing the Risk of Interaction Between Extractables and Leachable and Ther...

Presented by

Andrew Teasdale, Senior Principal Scientist at AstraZeneca and Piet Christieans, Phd,Scientific Director at Nelson Labs

About this talk

FULL TITLE: Assessing the Risk of Interaction Between Extractables and Leachable and Therapeutic Proteins Presented by Andrew Teasdale, Senior Principal Scientist Impurity management and External Advocacy at AstraZeneca Biologics and Peptides often present their own challenges in respect to leachables. They are typically administered parenterally and therefore there is a high risk of interaction between dosage form and packaging / administration system. They are often low dose and sensitive to structural modifications, this can impact Safety (immunogenicity), Quality (instability, aggregation) and Efficacy (loss of potency). This webinar will examine the potential risk factors through case study examples including reactive leachables, the impact of sterilisation and adverse events and their route cause. It will conclude by looking at opportunities to look predictively at potential issues and how this can be incorporated into product design Followed by Piet Christieans, Phd,Scientific Director at Nelson Labs

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