Osama Charhrour

Principal Scientist - New Modalities 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

Tuesday 9th March 2027
A Justified Limit for the Identification Threshold of Organic Impurities in Drug-Linker Intermediates Used to Produce Antibody-Drug Conjugates
  • A science-based justification for D-L related impurities identification threshold
  • Analysis of 47 ADCs data set to justify the proposal of related impurities identification threshold
  • A convergence-of-evidence methodology. Rather than relying on a single argument, we applied four independent quantitative criteria and asked: at what impurity level are all four criteria satisfied for all 47 clinical-stage ADCs in our dataset
Wednesday 10th March 2027
Aseptic Manufacturing of Antibody-Drug Conjugates – From Process Development to Validation
  • Despite frequently discussed challenges with respect to ADC complexity in development of analytics and bioconjugation processes, the challenges in the final steps – aseptic manufacturing of drug product (DP) has shared less spotlight
  • The distinctive physicochemical properties from ADCs compared to naked antibodies also lead to special technical challenges in DP manufacturing, for example, the highly potent/ cytotoxic payload necessitates containment strategies to protect operators and environment; in most cases, ADCs need to be lyophilized due to their poor liquid stability; light exposure controls are often implemented to overcome restricted photostability
  • This presentation will discuss the impacts from these challenges on DP process development, validation, manufacturing, and mitigations proposed to reduce risks
Osama Chahrour Principal Scientist, Chemical Development AstraZeneca
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