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

蛋白质生物制药，如单抗和干扰素，正越来越多地被用于各种医疗应用，如癌症治疗、心脏疾病、多发性硬化症和病毒感染的治疗。蛋白质类药物在稳定性、疗效和免疫原性等方面都存在一些问题，其中一些问题可以通过聚乙二醇化来解决，聚乙二醇化是指聚乙二醇化到蛋白质上。几种聚乙二醇化的生物制药蛋白已经获得了FDA等监管机构的批准，并已进入市场。蛋白质聚乙二醇化的改善包括生物半衰期的增加(从而减少了注射的频率)，以及蛋白质降解、免疫原性、疏水性和聚集倾向的降低。因此，拟议项目的总体目标是为聚乙二醇化生物制药开发具有成本效益的基于膜的制造方法。对于仿制药，这将导致较低的产品成本，从而扩大获得救命药物的机会。

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.