Pharmaceutical
Confidential Client
How DOE helped develop a stable, high-concentration human monoclonal antibody formulation with 2-year shelf life.
The Challenge
Liquid formula with active ingredient breaking down by aggregation. Needed 2-year shelf life stability. Unacceptable changes in drug activity, half-life, and immunogenicity.
The Solution
Screened 14 different excipients using 6 analyses in screening design. Chose best 6 contenders. Used I-optimal design with 7 analyses measuring aggregation. Combined results into desirability number.
The Results
Successfully produced stable formulation with 2-year shelf life. Found 4 separate interactions between excipient pairs. Chose optimal excipient combination.
"Experimental design techniques proved to be a valuable tool in optimizing the formulation."
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