الفهرس 
Analytical study on the stability of modified recombinant proteins
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Abstract
Biopharmaceuticals are medical drugs produced using biotechnology. The use of proteins has greatly expanded the field of molecular biology when compared to traditional small molecule drugs. The majority of biopharmaceuticals are recombinant or engineered versions of native eukaryotic proteins. Basically, most of the research in this field is directed towards assessment and/or improving the stability of these drugs. Polymer conjugation using polyethylene glycol (PEG); is known as pegylation, has become a leading technology for producing therapeutic proteins. Common reasons for the pegylation of a drug are to reduce its excretion by the kidneys, its degradation by proteolytic enzymes, its immunogenicity and to enhance its stability and water solubility. Owing to the complexity of biopharmaceuticals, regulatory bodies around the world require comprehensive drug substance characterization. Batch-to-batch comparisons, stability studies and profiling of product and process-related impurities should be conducted not only by the manufacturer but also by local regulatory authorities. This approach ensures efficacy and safety of marketed products especially in price-sensitive markets. To the best of our knowledge, the effect of various physicochemical factors on the stability of pegylated Interferon (PegIFN) and pegylated erythropoietin PegEPO have not been thoroughly explored