Anyone responsible for the management of the supply chain to support a pharmaceutical or biologic clinical trial can appreciate the challenges associated with an unexpected or otherwise urgent need to produce clinical drug product. Many factors can conspire to make a rapid response to such an urgent supply situation challenging. From a need to transfer sometimes complex manufacturing processes and test methods to availability of specific manufacturing components, it can be a daunting problem to identify, select, and engage a CMO/CDMO willing and able to meet the myriad of challenges. What measures then can a CMO take to help its clients respond when time is of the essence?
This article is the first in a series that describes some of the challenges and solutions available to pharmaceutical/biotech companies and their supply chain partners in the CDMO realm to ensure that critical clinical supply materials are ready when they are needed and how one CDMO, Singota Solutions, has positioned itself to meet these challenges.