Regulatory agencies like FDA or EMA expect a protein-based biologic to be characterized regarding its physicochemical and immunochemical properties, its biological activity, as well as regarding its purity and present impurities. Especially the evaluation of the biological activity including attributes responsible for target and receptor binding is, besides the safety, the most important critical quality attribute (CQA) of a biopharmaceutical drug or therapeutic.
Correct binding properties are not only essential to ensure the pharmaceutical activity but also to guarantee activation, deactivation, and transport within the human target tissue. An assessment of the binding properties is therefore fundamental for comparability studies of biosimilar products. With our Biacore 1K system we will be able to provide you a state-of-the-art surface plasmon resonance (SPR) platform that delivers fast and label-free data, for an in-depth characterization and comparison of your biopharmaceutical drug product. With its exceptional reliability, accuracy, and sensitivity, the Biacore platform represents the gold standard for SPR systems since many years, making it the preferred system to analyze and compare drug candidates.
Due to the large number of available sensor chips and the powerful software, the system is highly customizable, allowing us to set up tailored experimental pipelines for your specific needs. Our experienced scientists at Biofidus guide you in accordance with ICH guidelines and will provide you a suitable bioanalytical package for an appropriate SPR analysis.
In accordance with your needs, we adapt and, if required, qualify our platform methods tailored to your pharmaceutical product, its individual formulation matrix, and your distinct analytical question.
Get in contact with us to find the optimal strategy for your project and to speak directly from scientist to scientist.
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