Overcoming the challenges of liquid chromatography method transfer: A CDMO perspective

Regulations for Analytical development USFDA/ICH/USP perspectives Manu Grover M.S (Pharma) Business Development ManagerPharma Markets Santa Clara (US) [email protected] DE94720144 Outline ICH Guidelines and USP chapters Method development guidelines from ICH Journey of Method development related regulations. • ICH Q2(R2) •…

Case study | 000566 Liquid chromatography Method transfer onto the Thermo Scientific Vanquish HPLC/UHPLC platform: A CDMO perspective Authors Introduction Nolan Dean1, Larry Duncan1, Blake Bailey1, Themo Fisher Scientific Pharma Services Group (PSG, also known as Patheon) provides Sébastien Morin…

Analytical Method Transfer to Modern UHPLC Instruments Nolan Dean1, Sébastien Morin2, Larry Duncan1, Blake Bailey1, Carsten Paul3, 1Thermo Fisher Scientific, Greenville, NC, USA; 2Thermo Fisher Scientific, Mississauga, ON, Canada; 3Thermo Fisher Scientific GmbH, Germering, Germany Purpose: To develop a systematic…

HPLC and UHPLC Method Modernization and Method Development e-Book Introduction The demand for labs to develop faster, more sensitive, and robust liquid chromatography methods capable of meeting stringent regulatory criteria is a growing challenge faced by many industries. This guide…