1: Identification, selection, and management of partners (CMOs/CROs). 

2: Development of the manufacturing process and scale-up.

3: Master Batch Record Review (MBR), including in-process controls.

4: Ensure robust non-GMP and GMP manufacturing and batch analysis consistency.

5: Evaluation of the aseptic filling process and lyophilization program.

6: Identification of the perfect container closure system.

7: Stability program design and management. Including forced degradation testing.