Spike, Fate & Purge Studies
Eurofins CDMO has a strong experience in impurity control strategy from IND through to commercial stages. We have demonstrated track-record in the design and execution of impurity fate and purge studies. Our analyses consider the origin, clearance and ultimate fate of process-related organic or inorganic impurities, by-products and degradants, and are designed to meet program and Client requirements. We are able to assist and lead projects either as standalone for Clients seeking data to support external programs, or as part of wider efforts prior to PPQ and commercialization, often in tandem with process mapping studies.
Our experts use cutting-edge technologies to mimic manufacturing conditions such as PolyblockTM and MultimaxTM systems. We are able to offer rapid method development and alternative analyses such as LC/MS and NMR which are required for impurity identification and quantitation, and to scientifically support study conclusions.
Impurity synthesis
Eurofins CDMO offers services during the whole development process including managing impurities synthesis and control. We can identify, isolate, and synthesize process related impurities to support process development, analytical controls and regulatory requirements.
We are able to provide to our Clients a complete CMC Gap Analysis, Risk Assessment and impurities markers synthesis. Our main analysis tools are chromatography for the isolation of process impurities, LC/MS-MS/MS and multi-nuclear NMR for characterization. Our expert team masters “Spike. Fate, and Purge” studies to understand the origin and fate of process-related impurities.
To learn more