Top Four Things To Consider When Looking For A CDMO To Maximize Drug Substance Utilization

By Enda McKeon, Jon Best, and Jonathan Turkowski, AbbVie

Efficiently managing drug substance during the fill/finish process is a vital driver of overall manufacturing optimization, particularly for advanced therapeutics with high production costs. Minimizing product loss requires a holistic look at equipment design, mechanical capabilities, and operational strategies.

A primary consideration is the integration of advanced weight-checking technology. While traditional fill lines often rely on statistical sampling that can lead to large-batch forfeitures if process drift occurs, modern lines implement 100% non-destructive weight checks. Performing offline calibration before production runs helps eliminate the initial loss of vials, while real-time inline monitoring continuously corrects pump deviations to maintain strict filling accuracy.

Furthermore, evaluating line configuration options—such as Restricted Access Barrier Systems (RABS) versus isolators—plays a major role in protecting vulnerable formulations. Partnering with providers who emphasize automated intervention reduction and precise mechanical engineering ensures that high-value compounds are handled with maximum yield.