An Overview of Drug Substance Manufacturing Processes.

To develop a comprehensive understanding of pharmaceutical drug substance manufacturing (DSM) processes, we conducted a data mining study to examine 50 new drug applications (NDAs) approved in 2010-2016. We analyzed the prevalence of several frequently deployed in-process control (IPC) techniques and postreaction workup procedures, as well as the operational conditions specified for reactions and workups. Our findings show that crystallization and high-performance liquid chromatography (HPLC) were the most commonly used workup steps and in-process controls, respectively, in drug substance manufacturing.

Quantifying stability in gene list ranking across microarray derived clinical biomarkers.

Background: Identifying stable gene lists for diagnosis, prognosis prediction, and treatment guidance of tumors remains a major challenge in cancer research. Microarrays measuring differential gene expression are widely used and should be versatile predictors of disease and other phenotypic data. However, gene expression profile studies and predictive biomarkers are often of low power, requiring numerous samples for a sound statistic, or vary between studies.