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EFPIA Mock S2 Project Overview by amin138ir is a document available to read on EtoBox.

What is EFPIA Mock S2 Project Overview about?

The EFPIA Mock projects aim to illustrate quality by design (QbD) concepts for drug substance development and manufacturing through two example documents. One document focuses on a monoclonal antibody called Mockestuzumab, while the other focuses on a small molecule called Illustrain HCl. Both documents outline target molecules and proposed processes, and describe applying QbD principles such as defining critical quality attributes, identifying critical process parameters, and developing control strategies

Author

amin138ir

Language

EN