Design, Execution and Analysis of High Throughput Biological Formulation Screening to Accelerate Drug Product Development

Description:
At any point in time, there is always more that we would like to accomplish than there is time. This is certainly the case in pharmaceutical development. The development and application of automation to sample preparation has lowered the barrier to generating a wider array of samples. This has shifted the bottleneck towards analysis. The subsequent application of automation to the development of higher throughput analytical instruments and the associated methods has tip the balance even more towards analytics. The present barrier is rapid automated analysis of large data sets, oftentimes multivariate in nature. We are making headway on chipping away at this challenge.
In this work, we’ll explore these concepts through the JMP DOE design, execution, and analysis of high throughput formulation screening studies to investigate both biochemical and biophysical stability risks in product development. Execution considerations include minimizing material needs, streamlining sample preparation, method selection, and analytical data acquisition. Analysis considerations include organizing, parsing and pre-processing data, rank order risks, and data exploration and visualization tools to provide an interactive environment to gain insights and surface deeper questions from the data.

Speaker: Hanlin Ouyang - Merck