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In order to upstream the application of this approach from early stages of the development, this method was optimised and validated using smaller amounts of sample demonstrating the same levels of precision and accuracy.
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Critical Quality Attributes (CQAs) are typically defined early in development based on the quality target profile of the product. The complexity of the CQAs calls for the development of many different analytical methods.
Two-dimensional LC/MS is a powerful tool to speed up mAbs and
Mass spectrometry is a valuable tool for the development of biotherapeutics. This technique can be used in a GxP environment at every step of process development and for product optimisation.
Quality Assistance is a leading European Contract Research Organisation providing the pharmaceutical industry with all the analytical services required by EMA and FDA regulations for the development and marketing of innovative human medic