Fate & Purge services
Eurofins CDMO (Contract Development & Manufacturing Organization) experienced quality team works through the whole project with our clients to meet their phase appropriate quality and regulatory needs.
In that context, 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 lead them either as standalone projects 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.