How To Ensure Correct Component Selection When Outsourcing Production To A CMO

A growing biopharmaceutical company, developing injectable treatments for infectious diseases, outsourced its fill finish operations to a CMO, including all decisions regarding component selection for its container closure systems.

As the drug company expanded and gained approvals for additional indications for their drug, they observed that the costs for their elastomeric stoppers seemed to be much higher than expected. Upon further investigation, they discovered the CMO-recommended lyophilization stopper they were using was contributing to several operational inefficiencies, including sticking, and interlocking of stoppers during filling operations. The stoppers were also sticking to the freeze dryer shelf during the freeze-drying cycle. These challenges resulted in a significant reject rate of 40%, leading to inflated packaging costs for the drug manufacturer.

Find the solution in this case study.