Commercializing cell & gene therapies: a perspective from the quality function

The key modalities in cell and gene therapies each present unique challenges and opportunities, leading to a need for different asset requirements. The Lonza New Product Introduction Process and Lifecycle process enables a faster turnaround to manufacture and delivery of these therapies to patients. In this article, Lonza’s approach to de-risking development, industrialization, and delivery to cGMP manufacture is outlined, in order to enable the development of a commercially viable process.

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