By Dr. Sufia Karim and Dr. Steven Lang, Aragen Bioscience, Inc
How confident are you in your ability to reach appropriate titers for an unknown biologic?
This question is at the heart of decision-making when choosing a cell line development (CLD) platform. When pharmaceutical sponsors have the ability to do so, testing multiple platforms to determine which will produce optimal titers provides process insight and mitigates risk. However, platform testing requires sponsors and their partners to balance timelines against the amount of parallel work, arriving at a data-supported resolution as quickly as possible.
In many cases, vendors overpromise and underdeliver. A sponsor’s only recourse — most of the time — is to find a forthcoming and knowledgeable vendor that can provide insight into why a given timeline may be unrealistic, a budget may be miscalculated, or a cost of goods sold (COGS) may be overly optimistic.
This article reviews the CLD platform options, multiple platform testing, and next steps.