RYAN R. SASAKI
Advanced Chemistry Development Inc., 8 King Street East, Suite 107, M5C1B5 Toronto, ON, Canada

Abstract

The rapid identification, elucidation, and characterization of impurities is an intense and comprehensive undertaking. Presented is a perspective on a new laboratory informatics approach to improve productivity in this environment. Impurity Resolution Management (IRM) is a specific application of Unified Laboratory Intelligence (ULI) to identify and characterize impurities for control, resolution, and reporting during the development and acceptance of a new drug substance.

INTRODUCTION

The laboratory informatics industry has evolved with the delivery and deployment of ELN, LIMS, and Archiving systems that clearly support the business of science (1). Yet, despite the emergence of these technologies a 2011 survey of R&D professionals reveals that 88 percent of R&D organizations lack adequate systems to automatically collect data for reporting, analysis, and decision-making (2). The International Data Corporation (IDC) estimates an enterprise with 1,000 knowledge workers loses a minimum of $6 million a year in the time workers spend searching for - and not finding - needed information (3). As a result, many laboratory experiments represent expensive, time-consuming repeats of previous experiments, simply because the data cannot be found, or if found, cannot be reused. This issue clearly illustrates a need to continue to explore informatics technologies that support scientific activities that can demonstrate clear business value towards the ultimate goals of improving overall R&D productivity and time to market.

The major source of these problems that impede scientific workflows is a traditional one-and-don ...