Application Note

Cell And Gene Therapy Definitions For Raw Materials, Starting Materials, Drug Substance And Drug Product

By Martin Wisher, Ph.D., Senior Regulatory Consultant, Life Science Quality & Regulatory Management

cell therapy (002)

The complexity of processes to manufacture cell and gene therapy medicinal products can cause confusion around definitions of raw materials, starting materials, process intermediates, drug substance and drug products. This document will discuss the definitions of the above process components based upon statements to be found in recent regulatory guidance documents. Examples from cell and gene therapy processes will be given.

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