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

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检测项目方法转移

方案详情文

Analytical method transfer and method modernization can be a barrier to upgrading to the latest technologies. Revalidating an existing method while continuing to meet regulatory guidance can be a challenging and time-consuming endeavor. However, method modernization is often less difficult than the common perception, and good practices can be put in place to streamline and facilitate the process. This case study will address some of the concerns related to method transfer and provide guidance from a leading contract development and manufacturing organization (CDMO) authority. A method transfer guide onto the Thermo Scientific™ Vanquish™ UHPLC platform (CS000566)1 based on these guiding principles complements this document.

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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.

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产品配置单

检测仪器
赛默飞 Vanquish Flex UHPLC系统赛默飞液相色谱(LC)
￥100万 - 200万留言咨询
外设/附件
Chromeleon® 变色龙7色谱数据系统赛默飞工作站及软件
￥10万 - 30万留言咨询

赛默飞色谱与质谱为您提供《Overcoming the challenges of liquid chromatography method transfer: A CDMO perspective》，该方案主要用于化药新药研发中方法转移检测，参考标准《暂无》，《Overcoming the challenges of liquid chromatography method transfer: A CDMO perspective》用到的仪器有赛默飞 Vanquish Flex UHPLC系统、Chromeleon® 变色龙7色谱数据系统。

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