Biopharmaceuticals Test and Analysis Laboratory


Hülya Ayar-Kayalı, PhD

An extensive array for physicochemical characterization to GLP will be available, adhering to ICH Topic Q6B. According to the regulatory guidelines, iBG-izmir will offer a wide range of quality control testing services, including method development & validation, analytical chemistry, impurities analysis, purification and characterization of degradants to support biosimilar manufacturers throughout all stages of development. We will identify the primary and higher-order structure of glycoproteins and proteins, including monoclonal antibody products, at critical stages of development by using state-of-the-art instrumentation and standard operating protocols (SOPs). Full GLP-certified immunoassay capabilities, using ELISA, SPR, Western blot, and other technologies, will also be provided.