To demonstrate the safety of a drug, it is critical to have control over the process and the final drug product administered to the patient.

This implies an understanding of what aspects of the drug are critical (the critical quality attributes), what the final drug should look like (the quality target product profile), and what steps and factors in the manufacturing processes affect these the most (the critical process parameters). To understand the interplay between these factors, Quality by Design is often used as a strategy.

This consists of taking the existing knowledge of a product and manufacturing processes and using this to plan further experiments to increase the knowledge and understanding of the product and processes. It is an iterative approach, often amplified with statistical techniques such as design of experiments, to do this more efficiently.

Taking a holistic approach to CMC development, rather than seeing it as the sum of individual activities that need to be performed, greatly enhances the ability to bring true understanding, and control, to manufacturing.

Bert-Jan Haijema

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Bert-Jan Haijema

CMC Director

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