Ion-exchange chromatography (IEX)
Ion-exchange chromatography (IEX) is a widely used, high-throughput analytical technique that allows the separation of analytes based on differences in net surface charge.
The technique does not require organic solvents and is therefore frequently applied to characterize proteins in their native / active form. We offer, IEX on high-performance liquid chromatography (HPLC) instruments coupled with UV-, fluorescence-, refractive index- and/or multi-angle laser light scattering (MALLS) detection. We are experienced in performing IEX on a large selection of columns from various vendors, offering different bead-sizes, matrix materials and functional groups. Mobile phase compositions, particularly salt concentration and pH are optimized method specifically. With many years of experience in developing IEX methods, we are happy to apply our know-how during the development of a tailor-made IEX method for you.
Quality & biosafety level of this method
We provide all our analytical services with the highest quality standards. Each project is carried out by experienced scientists and every report or data presentation is comprehensively checked by a scientific reviewer. We offer this technology with the following quality and biosafety level:
Standardized methods or dedicated method development
For common sample types, we can often apply standardized methods with little setup effort. On top of this, our experienced analytical scientists perform in-depth method development or method optimization tailored to your drug substance, product type and development phase. Under GMP, we also offer full method validation or compendial method verification.
During method development, we tailor sample preparation, method settings, and data analysis to the needs of your project and sample.
For this purpose, we include a representative sample and, where available, suitable reference standards and stressed/degraded materials. This way, our analytical scientists can design a method that is highly suitable for your needs, stability indicating, as well as robust and repeatable. Upon request, we compile a detailed method description for your records.This can be applied under R&D and GMP. Read more
A method qualification is the initial assessment of the performance of an analytical procedure to show that it is suitable for the intended purpose.
During method qualification, our analytical scientists perform a documented testing that demonstrates that the analytical procedure meets certain acceptance criteria in several categories. These may include repeatability, linearity, intermediate precision, robustness and more. We compile a qualification plan and a qualification report including all relevant data.This can be applied under R&D and GMP. Read more
A method validation is the confirmation under highly controlled conditions that the performance of an analytical procedure is suitable for the intended purpose.
During method validation, our analytical scientists perform a documented testing, which demonstrates that the analytical procedure consistently produces a result that meets the pre-determined acceptance criteria. We compile a validation plan and a validation report including all relevant data.This can be applied under GMP. Read more