DOE Pharmaceutical Industry Application
You can improve your pharmaceutical products and processes, and increase your profits, without increasing costs.
Imagine your pharmaceutical product following a streamlined, optimized development process, moving quickly from research through FDA submission to manufacturing.
The FDA now says, “...It is the knowledge gained and submitted...not the volume of data collected, that forms the basis for science and risk-based submissions and regulatory evaluations”.
Design of Experiments has helped the world’s leading pharmaceutical companies develop high quality products and processes efficiently. Companies boost profitability by minimizing time to market on new products. Design of Experiments can cut your development time by two thirds!
Pharmaceutical Industry Actual Case Study
The bottom line: Our client successfully produced a stable, high concentration human monoclonal antibody formulation with a shelf life of two years. The principal scientist said, “...experimental design techniques...proved to be a valuable tool in optimizing the formulation.”
Our client had a liquid formula that needed to be stable for two years. The active ingredient was breaking down by aggregation, forming clumps in solution. This caused unacceptable changes in the formula's drug activity, half life, and immunogenicity. The client used Design of Experiments methodology to screen and eventually choose excipients, ingredients in the formula that minimize aggregation.
Experimenters studied 14 different excipients using six analyses in a screening design. They chose the best six excipient contenders.
The scientists then used an I-optimal design to measure the performance of these top six excipients. The client used seven analyses to measure the response “aggregation” and combined the seven analytical results to produce a “desirability” number.
They found four separate interactions between excipient pairs in formula, both synergistic and antagonistic. They chose the combination of excipients that met their two year shelf life goal.