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

Thermo Fisher Scientific Pharma Services Group (PSG, also known as Patheon) provides industry-leading pharma service solutions in drug development, clinical trials logistics, and commercial manufacturing. With more than 55 locations worldwide, expertise in chemical and biotherapeutic molecule drug substances, and drug products  across the product lifecycle, the Pharma Services Group is well regarded as a leader in pharma services. Addressing such a wide range of drug substances and products, as well as demanding timelines and operating in a cGMP environment, PSG needs to be flexible and have streamlined processes while continuing to be compliant with regulatory agency requirements. Analytical method transfer is an integral part of PSG drug development support, and by combining current regulatory guidance, industry best practices, and an understanding of the liquid chromatography platforms, successful method transfers are accomplished.