Jianxin Guo

Company: Eli Lilly & Co.

Job title: Director - Regulatory Chemistry Manufacturing & Controls Biotechnology

Seminars:

CMC Regulatory Considerations for Setting Small Molecule Impurity & Control Strategies 11:15 am

Understanding the regulatory frameworks for an ADC to reflect the production processes and the combined approach to quality Justifying the specification setting for small molecule impurity limits Regulatory benchmarking of critical quality attributes and control strategies for marketed ADC productsRead more

day: Day One