Drug Substance Manufacturing

Supporting Clinical as well as Commercial Requirements

All Clinical Drug Substance cGMP manufacturing will require a cell line
with a robust upstream and downstream process to support
Phase I and Phase II clinical studies

All Late Stage and Commercial Drug Substance cGMP
manufacturing programs will require scale-down
Proccess Validation and PPQ runs with established
upstream and downstream processes

We will help you navigate the selection of the correct CDMO partner for your programs