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LIVE WEBINAR

Webinar: Assessing the Risk of Interaction Between Extractables and Leachable and Therapeutic Proteins

May 14, 2020

4:00 pm CET

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.

Piet Christiaens

Piet Christiaens

PhD
Scientific Director

Piet Christiaens received his Ph.D. from the Analytical Chemistry Department of the University of Leuven (Belgium) in 1991. From 1992 to 1997, he was Lab Manager in two CROs. From 1997 to 2000, he worked as an independent consultant with Shell Chemical Company in Houston, Texas (US), working on hydrogenated triblock co-polymers. Since 2001, Piet...