Synthesis, purification and analysis of PEGylated proteins using membrane based techniques

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Protein biopharmaceuticals such as monoclonal antibodies and interferons are increasingly being used for arange of medical applications such as cancer therapy, and the treatment of cardiac diseases, multiple sclerosis and viral infections. Protein drugs have major stability, therapeutic effectiveness and immunogenicity problems, some of which can be addressed through PEGylation, which refers to the attachment of polyethylene glycol (PEG) to proteins. Several PEGylated biopharmaceutical proteins have been approved by regulatory agencies like the FDA and these have entered the market. The improvements resulting from protein PEGylation include an increase in biological half-life (and thereby decrease in the frequency of injections), and decrease in proteolytic degradation, immunogenicity, hydrophobicity and tendency to aggregate. The overall objective of the proposed project is therefore the development of cost-effective membrane-based manufacturing methods for PEGylated biopharmaceuticals. For generic products, this would lead to lower product cost and therefore wider access to life saving drugs.