1. INTRODUCTION AND SCOPE

Many medicinal products are produced through recombinant technology via a host cell (e.g., bacteria, yeast, or mammalian, insect, or plant cell lines). During the manufacture of such products, some amount of non-product, host cell-derived material will inevitably be introduced into the process stream. This process results in a mixture of the desired product and host cell-derived impurities, including host cell proteins (HCPs), and other process-related impurities that will be targeted for clearance through bioprocessing.