Thesis (Ph.D.) - Cairo University - Faculty of Pharmacy - Department of Analytical Chemistry

The evaluation of quality attributes of biopharmaceuticals finished products is a defying issue.The conventional analytical techniques are of a limited value for determination of various quality aspects of biomolecules, especially if not used in collaborative protocols.The goal of multi-method strategies is to demonstrate the similarity between production batches by precisely characterizing their quality. Other vital aspects of monitoring the quality of biological products are the low stability and bio-similarity assessment.Moreover, finding an easy and new way to detect the target biomolecules in complex matrices is an increasing demand, especially in clinical applications. In some cases, there is a necessity to switch to bioassays including affinity-based assays and detection strategies to solve the problem of matrix complexity and test the binding, affinity and activity properties.Many of these assays require the use of biorecognition species, which greatly elevate the cost of analysis and add a burden on the analyst for handling and preservation

Issued also as CD