14th May 2020 – 16:00 CET
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). During this webinar, Andrew Teasdale (Senior Principal Scientist Impurity management and External Advocacy at AstraZeneca) and Piet Christiaens PhD, will examine the potential risk factors through case studies 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.