Skip to main content
x

Unique Control System Based on QBD principles

Unique Control System Based on QBD principles

Unique Control System Based on QBD principles

Quality by Design (QbD) is often an efficient approach where the biosimilar development is outlined based on a robust risk management system. 

In arrange to set the quality attributes, we execute a thorough examination of the reference medication; so that Critical Quality Properties (CQAs), or the characteristics that affect the quality of a biosimilar, can be determined.

Then our unique control system which lets us to evaluate and examine whether quality goals are met at each critical step. 

Finally, only the highest-quality pilot batches at lab that surpasses the quality standards can move up to the next stage of scale-up process.