方案摘要
方案下载| 应用领域 | 制药/生物制药 |
| 检测样本 | 化药新药研发 |
| 检测项目 | |
| 参考标准 | / |
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.
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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Thermo Fisher Scientific iCAP TQe ICP-MS/MS测定土壤和沉积物多种元素
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