Osama Charhrour
Chair of Astrazeneca Impurities Advisory Group AstraZeneca
Osama’s expertise spans process characterization, analytical technology, and the formulation of precise control strategies tailored specifically for ADCs, supporting regulatory compliance and commercial success. As Chair of the Impurity Advisory Group at AstraZeneca, Osama leads initiatives to assess, control, and mitigate impurities in complex manufacturing, with a particular focus on application to real life scenarios. Through external advocacy at EFPIA and the IQ Consortium, he has championed industry-wide best practices and collaborative standards for complex biologics. With a track record of impactful publications, he has advanced methodologies for optimizing ADC manufacturing and ensuring robust quality control throughout product lifecycle.
Seminars
- Issuing guidance for industry sponsors and regulatory agencies to assess safety of impurities in ADC drug-linker intermediates
- Evaluating conjugatable impurities in ADC drug- linkers for potential toxicological risks for all clinical stage and approved ADCs
- Developing a methodology to assess the level of concern and justify specifications for non- conjugatable organic impurities
- Qualification divergence: drug-linker impurities versus small molecule API impurities
