Harmonized Strategy of New UHPLC Implementation in Pharmaceutical R & D and CRO/CMO QC Laboratories (#353)

Harmonized Strategy of Ultra-High Pressure Liquid Chromatography Implementation in Pharmaceutical R & D and Contract Research/Manufacturing Organization Laboratories

Naijun Wu, Ph.D.
Analytical Research and Development
Celgene Corporation
86 Morris Avenue, Summit, NJ 07901, USA

Wayne M. Mullett, Ph.D.
Roy Errington Building, 447 March Road
Ottawa, Ontario, Canada, K2K 1X8

Eugene Gong, Ph.D.
Analytical R&D, Wuxi Apptec Co. Ltd.
288 Fute Zhong Road, Shanghai, China 200131

High performance liquid chromatography (HPLC) is one of the most widely used analytical technologies. Commercial ultra-high pressure liquid chromatography (UHPLC), a breakthrough in HPLC development, was introduced nearly a decade ago and its benefits have been widely recognized by both academia and industry. However, reluctance to using UHPLC still exists in the pharmaceutical industry, especially in quality control (QC) and contract research/manufacturing organization (CRO/CMO) laboratories. This hesitation in UHPLC utilization significantly slows implementation of UHPLC and the realization of its benefits. Furthermore, the additional method transfer activities required due to use of UHPLC in R&D and HPLC in QC and CRO/CMO laboratories reduces the efficiency of method implementation and slows down the work flow of pharmaceutical R & D and manufacturing practice. In this section, the latest development in UHPLC is introduced. UHPLC benefits and applications in pharmaceutical laboratories are demonstrated. The key barriers of UHPLC implementation are identified and discussed. Lastly, a harmonized strategy of UHPLC implementation in pharmaceutical R&D, QC, and CRO/CMO laboratories is described.
Last update: Dec 28, 2015