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.