QbD at a CMO

The QbD guidance since it came out in 2006 is increasingly setting the tone for regulatory expectations for biotech products. This guidance sets expectations throughout the product lifecycle starting with process development, moving on to process characterization and design space mapping and then moving on to large scale conformance lots and eventually to post-commercial process monitoring. As a small CMO organization, KBI presents conducts most of its QbD activities during the process development (clinical entry) and process characterization (stand-alone studies to support licensure filing) phases. Using examples, the presentation will highlight how a small CMO organization can efficiently develop robust and high yielding production processes as well as document these in a ‘QbD friendly’ package. The presentation will also highlight scale-down process characterization and validation studies where having a robust data set helps address key questions during product approval and helps generate a knowledge set that can assist with process monitoring.