Redwan El-Rashdy M
Antibody Laboratory, Protein Research Department, GEBRI, Mubarak City for Scientific Research and Technology Applications, New Borg EL Arab, 21394, Alexandria, Egypt.
Hum Antibodies. 2007;16(3-4):137-58.
By definition, biopharmaceuticals includes the recombinant therapeutics proteins, monoclonal antibody and nucleic acid based-products used for medical purposes, which produce through the biotechnology. It has grown enormously during last 25 years, even that each four pharmaceuticals product contains one biopharmaceutical product. This class of therapeutical generates in excess of $50 billion in sales annually. About 150 biopharmaceuticals have now received the medical approval. Actually, this white dimension is supported with strong R&D. The cost-estimated of total R&D per single biopharmaceutical approved molecule will reach $1318 million. The majority of these materials are development and producing in mammalian cell line (70%), prokaryotic systems (15%), and yeast (5%), respectively. Few products are animal-derived, however the rest are completely from human-genes or humanized.
根据定义，生物制药包括用于医疗目的的重组治疗性蛋白质、单克隆抗体和基于核酸的产品，这些产品是通过生物技术生产的。在过去25年中，它有了巨大的发展，甚至每四种药品中就有一种是生物制药产品。这类治疗药物每年的销售额超过500亿美元。目前约有150种生物制药已获得医疗批准。实际上，这个领域得到了强大研发的支持。每一个获批的生物制药分子的总研发成本估计将达到13.18亿美元。这些产品大部分分别在哺乳动物细胞系（70%）、原核系统（15%）和酵母（5%）中进行开发和生产。很少有产品是动物源性的，其余的则完全来自人类基因或人源化。
