Sarah Muller
Senior Scientist, Biologics Global MSAT Gilead Sciences
Sarah Muller is a Senior Scientist for Biologics Global MSAT at Gilead Sciences. She serves as the subject matter expert for conjugation operations, supporting ADC products through commercial manufacturing, technology transfer, process validation, and regulatory submissions. Her work spans from commercial process optimization, manufacturing investigations, site-to-site transfers, and next-generation process development to enable robust and compliant commercialization of biologics.
Seminars
Developing, optimising and maturing ADC process is the cornerstone to streamline ADC manufacturing and demonstrate confidence to regulatory bodies
Spanning process scale-up from preclinical phase up to GMP manufacturing, this workshop is your best opportunity to converse with ADC technical experts on all facets of process development including in-process impurity control and post-conjugation purification to guarantee your ADC product quality
Workshop highlights include:
- Navigating ADC process scale up from early preclinical phase, through GLP toxicity, to GMP manufacturing
- Understanding the use and applications of inprocess controls in ADC drug-linker synthesis and conjugation
- Exploring process development and post conjugation purification for increasingly complex bioconjugates
- Mitigating facility and scale differences during ADC technology transfer
- Ensuring flexibility operationally in ADC supply chain and shipping strategies
- Implementing optimal filing approaches and validation strategies to support multiple global sites and commercial manufacturing
