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
- Showcasing a science-based justification for D-L related impurities identification threshold
- Analysing a 47-ADC data set to justify the proposal of related impurities identification threshold
- Applying four independent quantitative criteria to address what impurity levels are all four criteria satisfied for all 47 clinical-stage ADCs in our dataset
This workshop aims to identify the unique manufacturing challenges of next-generation ADCs, including multi-step conjugation, yield optimisation, analytical characterisation, and scale-up considerations by sharing best practices for process development.
Key Questions:
- How do we optimise conjugation processes for dual-payload ADCs?
- What strategies reduce manufacturing costs while maintaining quality?
- What are the critical process parameters for bispecific ADC manufacturing?
