White Paper

A QbD Approach To Freeze Drying Of Cytotoxic Compounds

Source: Biopharma Technology Limited

By Dr Kevin Ward

Quality by Design (QbD) is a systematic approach to ensure that the quality of the product is built into production processes from the outset, rather than being tested once development has commenced.

This requires gaining an understanding of the product and each unit operation involved: the requirements of the product and the effect of any changes to it, the various process steps involved and the robustness within these steps, as well as robustness of the end product.